Trial Outcomes & Findings for Recovery and Analgesia After Surgery for Gynecological Cancer (NCT NCT02026687)
NCT ID: NCT02026687
Last Updated: 2019-09-24
Results Overview
From day of surgery (Day 0) until discharge after surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay, an expected average of 4 days
Results posted on
2019-09-24
Participant Flow
Participant milestones
| Measure |
Epidural Analgesia
The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.
Epidural
|
Intrathecal Analgesia
The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.
Intrathecal
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Epidural Analgesia
n=40 Participants
The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour.
Epidural
|
Intrathecal Analgesia
n=40 Participants
The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia.
Intrathecal
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 14.5 • n=40 Participants
|
58.5 years
STANDARD_DEVIATION 8.5 • n=40 Participants
|
58.7 years
STANDARD_DEVIATION 8.9 • n=80 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 4 daysFrom day of surgery (Day 0) until discharge after surgery
Outcome measures
| Measure |
Epidural
n=40 Participants
The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
|
Spinal
n=40 Participants
The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
|
|---|---|---|
|
Length of Stay
|
4.3 days
Interval 3.5 to 5.2
|
3.3 days
Interval 3.1 to 4.8
|
SECONDARY outcome
Timeframe: Preoperatively and until 6 weeks after surgeryThe questionnaire Short Form with 36 questions "SF-36" will be used preoperatively and at 6 weeks after surgery. The SF-36 consists of eight scaled subscores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental Health) and two Component summary scores (physical Component summary scoer, mental component summary score). A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Epidural
n=40 Participants
The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
|
Spinal
n=40 Participants
The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
|
|---|---|---|
|
Change in Quality of Life
SF-36 Physical component summary score baseline
|
44 units on a scale
Interval 34.0 to 53.0
|
45 units on a scale
Interval 34.0 to 53.0
|
|
Change in Quality of Life
SF-36 Physical component summary score day 42
|
39 units on a scale
Interval 34.0 to 44.0
|
38 units on a scale
Interval 35.0 to 42.0
|
|
Change in Quality of Life
SF-36 mental component summary score baseline
|
46 units on a scale
Interval 35.0 to 52.0
|
46 units on a scale
Interval 35.0 to 51.0
|
|
Change in Quality of Life
SF-36 mental component summary score day 42
|
49 units on a scale
Interval 34.0 to 53.0
|
51 units on a scale
Interval 39.0 to 55.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of surgery (day 0) until 6 weeks after surgeryPain at rest will be assessed using a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Pain is documented on the day of surgery (day 0), 3 times daily postoperative day 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35 and 42. Scale: NRS Minimum value:0 Maximum value: 10. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Epidural
n=40 Participants
The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
|
Spinal
n=40 Participants
The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
|
|---|---|---|
|
Change in Pain
Pain at rest Day 35
|
0.3 units on a scale
Interval 0.1 to 0.5
|
0.3 units on a scale
Interval 0.0 to 0.6
|
|
Change in Pain
Pain at rest Day 0
|
1.5 units on a scale
Interval 0.8 to 2.1
|
2.7 units on a scale
Interval 2.0 to 3.4
|
|
Change in Pain
Pain at rest Day 1
|
1.6 units on a scale
Interval 1.0 to 2.3
|
3.2 units on a scale
Interval 2.6 to 3.8
|
|
Change in Pain
Pain at rest Day 2
|
1.5 units on a scale
Interval 0.9 to 2.1
|
2.1 units on a scale
Interval 1.5 to 2.7
|
|
Change in Pain
Pain at rest Day 3
|
2.9 units on a scale
Interval 2.2 to 3.6
|
1.4 units on a scale
Interval 0.8 to 2.1
|
|
Change in Pain
Pain at rest Day 4
|
1.4 units on a scale
Interval 0.8 to 1.9
|
1.6 units on a scale
Interval 1.1 to 2.2
|
|
Change in Pain
Pain at rest Day 5
|
1.1 units on a scale
Interval 0.7 to 1.6
|
1.2 units on a scale
Interval 0.7 to 1.7
|
|
Change in Pain
Pain at rest Day 6
|
1.0 units on a scale
Interval 0.5 to 1.4
|
1.1 units on a scale
Interval 0.7 to 1.5
|
|
Change in Pain
Pain at rest Day 7
|
1.1 units on a scale
Interval 0.5 to 1.6
|
1.0 units on a scale
Interval 0.6 to 1.3
|
|
Change in Pain
Pain at rest Day 14
|
0.8 units on a scale
Interval 0.4 to 1.2
|
0.7 units on a scale
Interval 0.2 to 1.2
|
|
Change in Pain
Pain at rest Day 21
|
0.5 units on a scale
Interval 0.1 to 0.8
|
0.3 units on a scale
Interval 0.0 to 0.6
|
|
Change in Pain
Pain at rest Day 28
|
0.2 units on a scale
Interval 0.0 to 0.3
|
0.2 units on a scale
Interval 0.0 to 0.4
|
|
Change in Pain
Pain at rest Day 42
|
0.5 units on a scale
Interval 0.0 to 0.9
|
0.1 units on a scale
Interval 0.0 to 0.2
|
Adverse Events
Epidural
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Spinal
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epidural
n=40 participants at risk
The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
|
Spinal
n=40 participants at risk
The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
|
|---|---|---|
|
Surgical and medical procedures
Intensive care treatment
|
2.5%
1/40 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Surgical and medical procedures
Surgical intervention
|
2.5%
1/40 • Number of events 1
|
15.0%
6/40 • Number of events 6
|
Other adverse events
| Measure |
Epidural
n=40 participants at risk
The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the
|
Spinal
n=40 participants at risk
The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day.
|
|---|---|---|
|
Surgical and medical procedures
Deviation from normal postoperative cause
|
32.5%
13/40 • Number of events 13
|
20.0%
8/40 • Number of events 8
|
|
Surgical and medical procedures
Pharmacological treatment
|
15.0%
6/40 • Number of events 6
|
15.0%
6/40 • Number of events 6
|
Additional Information
Dr Lena Nilsson
Dept of anaesthesia, Linköping University Hospital, Sweden
Phone: 0046101030000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place