Trial Outcomes & Findings for Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia (NCT NCT03021096)
NCT ID: NCT03021096
Last Updated: 2025-03-04
Results Overview
Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Recruitment status
COMPLETED
Target enrollment
108 participants
Primary outcome timeframe
14 days after surgery for each patient
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
Total Shoulder Surgery Patients
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Overall Study
STARTED
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108
|
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Overall Study
COMPLETED
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102
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Total Shoulder Surgery Patients
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Overall Study
Lost to Follow-up
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4
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Overall Study
Protocol Violation
|
2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Age, Continuous
|
66 years
STANDARD_DEVIATION 9 • n=102 Participants
|
|
Sex: Female, Male
Female
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48 Participants
n=102 Participants
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Sex: Female, Male
Male
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54 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: 14 days after surgery for each patientQuantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Numeric Rating Scale Pain Scores at Post-operative Day 14
NRS with movement
|
3.1 score on a scale
Standard Deviation 2.3
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Numeric Rating Scale Pain Scores at Post-operative Day 14
NRS at rest
|
1.6 score on a scale
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgeryPopulation: some patients did not fill out questionnaire or were lost to follow up.
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". A lower score is a better outcome.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD1 at rest
|
1.6 score on a scale
Standard Deviation 2.1
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD90 at rest
|
0.8 score on a scale
Standard Deviation 1.7
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD90 with movement
|
1.7 score on a scale
Standard Deviation 2.2
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD1 with movement
|
2.7 score on a scale
Standard Deviation 3
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|
Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD3 at rest
|
2.8 score on a scale
Standard Deviation 3.3
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD3 with movement
|
4.7 score on a scale
Standard Deviation 2.4
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD7 at rest
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2.3 score on a scale
Standard Deviation 2.4
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Numeric Rating Scale (NRS) Pain With Movement and at Rest.
NRS POD7 with movement
|
3.9 score on a scale
Standard Deviation 2.3
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SECONDARY outcome
Timeframe: Days 1 day, 3 days, 7 days after surgeryPopulation: some patients were lost to follow up.
Measured in milligrams taken. A lower consumption is a better outcome.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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Opioid Consumption (in Past 24 Hours)
POD1
|
17.5 oral morphine equivalents (mg)
Interval 3.9 to 50.1
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Opioid Consumption (in Past 24 Hours)
POD3
|
30 oral morphine equivalents (mg)
Interval 7.4 to 63.2
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Opioid Consumption (in Past 24 Hours)
POD7
|
10 oral morphine equivalents (mg)
Interval 0.0 to 37.5
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SECONDARY outcome
Timeframe: Day 1 after surgeryThe Opioid-Related Symptom Distress Scale (ORSDS) is calculated by taking the average of the three symptom distress dimensions. Frequency will be assessed using a 4 point scale: 1, rarely 2, occasionally 3, frequently 4, almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1, slight 2, moderate 3, severe 4, very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1, not at all 2, a little bit 3, somewhat 4, quite a bit 5, very much with 1 being the lowest and 5 being the highest. A higher score indicates worse outcomes. The total score for each participant is calculated and the median score for all participants is reported.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Opioid Related Symptom Distress Scale
|
0.3 score on a scale
Interval 0.1 to 0.5
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SECONDARY outcome
Timeframe: Day 14 after surgery and 3 months after surgeryPopulation: some patients were lost to follow up or did not answer questionnaire.
Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Range of Motion
14 days after surgery extension
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15.8 degrees
Standard Deviation 5.8
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Range of Motion
3 months after surgery extension
|
35 degrees
Standard Deviation 21.2
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SECONDARY outcome
Timeframe: Day 14 after surgeryPopulation: some patients were lost to follow up or did not complete questionnaire. 32 people were reported to have bruising and size (in centimeters) of their bruises were measured.
Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=32 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Severity of Bruising
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1.5 cm
Standard Deviation 1.9
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SECONDARY outcome
Timeframe: Day 1 after surgeryThe Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression in a general medical population of patients. a lower score is a better outcome. Each item on the questionnaire is scored from 0-3 and a person's total score can ranged from 0 = normal and 21 = abnormal for either anxiety or depression. Scale range: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) A total score for each participant was calculated and then all participants' scores were averaged.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Hospital Anxiety and Depression Scale
Anxiety
|
4.1 score on a scale
Standard Deviation 3.3
|
|
Hospital Anxiety and Depression Scale
Depression
|
3.9 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day 1 and 14 after surgeryPopulation: some patients were lost to follow up.
The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following: 1. Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity. 2. Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction. 3. Interference with sleep: Rated on a 0-10 scale, where 0 means "does not interfere" and 10 means "completely interfere" A higher rating means more interference. 4. Nausea \& Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe. 5. Drowsiness: Rated on a 0-10 scale, where 0 means "not at all" and 10 means "extremely". A higher rating means more severe. Each question score for each participant was added up and divided by the total number of participants to obtain an average score of 0-10 at each timepoint.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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PainOUT Questionnaire
POD14 - Worst pain
|
4 score on a scale
Interval 2.0 to 6.0
|
|
PainOUT Questionnaire
POD1 - Interference with sleep
|
0 score on a scale
Interval 0.0 to 2.0
|
|
PainOUT Questionnaire
POD1 - Itching
|
0 score on a scale
Interval 0.0 to 0.0
|
|
PainOUT Questionnaire
POD1 - Worst pain
|
2 score on a scale
Interval 0.0 to 5.0
|
|
PainOUT Questionnaire
POD1 - Pain severity
|
0 score on a scale
Interval 0.0 to 0.0
|
|
PainOUT Questionnaire
POD14 - Pain severity
|
0 score on a scale
Interval 0.0 to 10.0
|
|
PainOUT Questionnaire
POD14 - Interference with sleep
|
0 score on a scale
Interval 0.0 to 5.0
|
|
PainOUT Questionnaire
POD1 - Nausea
|
0 score on a scale
Interval 0.0 to 0.0
|
|
PainOUT Questionnaire
POD14 - Nausea
|
0 score on a scale
Interval 0.0 to 0.0
|
|
PainOUT Questionnaire
POD14 - Itching
|
0 score on a scale
Interval 0.0 to 1.0
|
|
PainOUT Questionnaire
POD1 - Drowsiness
|
0 score on a scale
Interval 0.0 to 5.0
|
|
PainOUT Questionnaire
POD14 - Drowsiness
|
0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Day of SurgeryThe pain catastrophizing scale (PCS) evaluates a person's pain experience by asking them how they feel and what they think about when they are in pain. The questionnaire uses a 5-point Likert scale, with answers ranging from 0 (never) to 4. (always). The total score is the sum of the individual item scores and ranges from 0 to 52. A lower score indicates a more positive outcome.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
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Pain Catastrophizing Scale (PCS)
|
12 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Day of SurgeryThe symptom severity (SS) scale assesses four symptoms that are thought to be defining in a fibromyalgia diagnosis. The four symptoms assessed by the criteria are as follows: 1. Fatigue 2. Waking from sleep feeling unrefreshed 3. Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension) 4. Somatic symptoms (physical sensations such as pain, dizziness, nausea, fainting, or bowel disorders) Each of the 4 symptoms is graded on a scale of 0 to 3, with 0 indicating no symptoms, 1 indicating mild symptoms, 2 indicating moderate symptoms, and 3 indicating severe symptoms. The sum of the scores for each of the 4 symptoms is summed to produce the SS total score. The SS total score has a minimum score of 0 and a maximum score of 12. The higher score means worst outcome. The sum score for each participant is calculated and then the average score for all participants is reported.
Outcome measures
| Measure |
Total Shoulder Surgery Patients
n=102 Participants
In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.
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|---|---|
|
Fibromyalgia Scale. a Lower Score is a Better Outcome.
|
5.5 score on a scale
Standard Deviation 3.4
|
Adverse Events
Total Shoulder Surgery Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Jacques Yadeau
Hospital for Special Surgery, Anesthesiology
Phone: 2126061036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place