Trial Outcomes & Findings for Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose (NCT NCT02009722)
NCT ID: NCT02009722
Last Updated: 2016-07-25
Results Overview
Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score \<4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
12 hours after administration of spinal anesthesia
Results posted on
2016-07-25
Participant Flow
Participant milestones
| Measure |
Intrathecal Hydromorphone
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
43
|
|
Overall Study
Received Intervention
|
41
|
42
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Intrathecal Hydromorphone
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Did not receive intervention
|
0
|
1
|
Baseline Characteristics
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Baseline characteristics by cohort
| Measure |
Intrathecal Hydromorphone
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
30.6 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
30.5 years
STANDARD_DEVIATION 4.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 hours after administration of spinal anesthesiaPopulation: The primary outcome was determining the optimal dose of IT morphine and IT hydromorphone for patients undergoing cesarean delivery. Study was designed to determine the ED90 (effective dose in 90% patients; effective dose meaning a VAS score for pain of 3 or less at 12 hours after spinal placement).
Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score \<4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients
|
75 micrograms
|
150 micrograms
|
SECONDARY outcome
Timeframe: 6 hours after spinal administrationPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Side Effects: Pruritus
|
23 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 6 hours after spinalPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Side Effects: Nausea
|
11 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 6, 12, and 24 hours after spinal administrationPatients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=40 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Side Effects: Sedation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 hours after spinalPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Pruritus
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 24 hours after spinalPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Pruritus
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 12 hours after spinalPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Nausea
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 24 hours after spinalPopulation: The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis
Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Nausea
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: First 24 hoursPopulation: patients receiving most commonly used doses of IT medication (50,75,100 mcg for hydromorphone; 100, 150 mcg for morphine)
number of patients needing medication treatment for nausea in first 24 hours
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Treatment for Nausea
|
13 participants
|
17 participants
|
SECONDARY outcome
Timeframe: First 24 hours after spinalPopulation: only patients receiving most commonly used doses of IT hydromorphone (50,75,100 mcg) and morphine (100,150 mcg)
The number of patients needing medical treatment for pruritus in first 24 hours after surgery
Outcome measures
| Measure |
Intrathecal Hydromorphone
n=33 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=39 Participants
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Treatment for Pruritus
|
8 participants
|
4 participants
|
Adverse Events
Intrathecal Hydromorphone
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Intrathecal Morphine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intrathecal Hydromorphone
n=41 participants at risk
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
|
Intrathecal Morphine
n=42 participants at risk
Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.
Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Moderate to Severe Pruritus
|
65.9%
27/41 • Number of events 27
Hydromorphone arm: 41 patients received the intervention, 40 were analyzed Morphine arm: 43 patients were randomized to this arm, 42 received the intervention (thus the denominator for adverse events) and 40 were analyzed
|
52.4%
22/42 • Number of events 22
Hydromorphone arm: 41 patients received the intervention, 40 were analyzed Morphine arm: 43 patients were randomized to this arm, 42 received the intervention (thus the denominator for adverse events) and 40 were analyzed
|
|
Gastrointestinal disorders
Moderate to Severe Nausea
|
31.7%
13/41 • Number of events 13
Hydromorphone arm: 41 patients received the intervention, 40 were analyzed Morphine arm: 43 patients were randomized to this arm, 42 received the intervention (thus the denominator for adverse events) and 40 were analyzed
|
40.5%
17/42 • Number of events 17
Hydromorphone arm: 41 patients received the intervention, 40 were analyzed Morphine arm: 43 patients were randomized to this arm, 42 received the intervention (thus the denominator for adverse events) and 40 were analyzed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place