Trial Outcomes & Findings for Dexamethasone for Post Cesarean Delivery Analgesia (NCT NCT01868633)
NCT ID: NCT01868633
Last Updated: 2017-09-19
Results Overview
Comparison of postoperative opioid analgesia use between the 2 groups
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
24 hours
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
Dexamethasone & Spinal Morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone for Post Cesarean Delivery Analgesia
Baseline characteristics by cohort
| Measure |
Dexamethasone & Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.69 Years
STANDARD_DEVIATION 4.02 • n=5 Participants
|
31.65 Years
STANDARD_DEVIATION 5.83 • n=7 Participants
|
31.67 Years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursComparison of postoperative opioid analgesia use between the 2 groups
Outcome measures
| Measure |
Dexamethasone & Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Postoperative Analgesia
|
11.8 milligrams of morphine
Interval 5.0 to 20.0
|
15 milligrams of morphine
Interval 5.0 to 22.5
|
SECONDARY outcome
Timeframe: 24 hoursPain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with "no pain" = 0 and "the worst possible pain = 10). Pain was assessed at rest and with movement
Outcome measures
| Measure |
Dexamethasone & Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain at rest @ 0-6hr
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 1.0 to 3.0
|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain at rest @ 6-12hr
|
1 units on a scale
Interval 0.0 to 1.0
|
2 units on a scale
Interval 1.0 to 3.0
|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain at rest @ 12-24hr
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 1.0 to 3.0
|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain with movement @ 12-24hr
|
4 units on a scale
Interval 3.0 to 5.0
|
4 units on a scale
Interval 3.0 to 5.0
|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain with movement @ 0-6hr
|
4 units on a scale
Interval 1.0 to 5.0
|
4.5 units on a scale
Interval 3.0 to 5.0
|
|
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain with movement @ 6-12hr
|
3 units on a scale
Interval 2.0 to 4.0
|
4 units on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.
Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group
Outcome measures
| Measure |
Dexamethasone & Spinal Morphine
n=24 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=18 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Quality of Recovery
|
180 units on a scale
Standard Deviation 10
|
177 units on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 24 hoursPatients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)
Outcome measures
| Measure |
Dexamethasone & Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=26 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Incidence and Severity of Nausea and Pruritus
Nausea @ 0-6hr
|
6 units on a scale
Interval 2.0 to 10.0
|
2.5 units on a scale
Interval 0.0 to 7.0
|
|
Incidence and Severity of Nausea and Pruritus
Pruritus@ 0-6hr
|
5 units on a scale
Interval 2.0 to 8.0
|
3 units on a scale
Interval 1.0 to 6.0
|
|
Incidence and Severity of Nausea and Pruritus
Nausea @ 6-12hr
|
0 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 2.0
|
|
Incidence and Severity of Nausea and Pruritus
Pruritus @ 6-12hr
|
3 units on a scale
Interval 2.0 to 7.0
|
0 units on a scale
Interval 0.0 to 2.0
|
|
Incidence and Severity of Nausea and Pruritus
Nausea @12-24hr
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Incidence and Severity of Nausea and Pruritus
Pruritus @ 12-24hr
|
2 units on a scale
Interval 1.0 to 4.0
|
1 units on a scale
Interval 0.0 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted
Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups
Outcome measures
| Measure |
Dexamethasone & Spinal Morphine
n=19 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone
|
Placebo Injection and Spinal Morphine
n=18 Participants
intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively
Placebo
|
|---|---|---|
|
Number of Participants With Chronic Pain After Cesarean Delivery
|
0 Participants
|
0 Participants
|
Adverse Events
Dexamethasone & Spinal Morphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Injection and Spinal Morphine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place