Postoperative Pain
Conditions
Keywords
Cesarean delivery, Analgesia, Pain, Dexamethasone, intrathecal morphine, spinal anesthesia
Brief summary
The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain. We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain
Detailed description
After the subjects consent to participate in the study they will be transferred to the operating room for their scheduled cesarean delivery. They will have their routine spinal anesthesia with the dosages of drugs used standardized, and a standardized regimen to manage hypotension. After delivery of the baby the subjects will be administered either the study drug or placebo depending on the randomization. The subjects will then be prescribed a standard post-operative analgesia regimen. The subjects will then be interviewed at 12,24 and 48 hours post cesarean delivery. During the interview the subjects will be asked to rate their pain, nausea and vomiting and pruritus. They will also be asked to rate their quality of recovery from the surgery using Quality of Recovery-40 questionnaire. The subjects will be contacted 6 months after the study to rate their pain using a Short-Form McGill Pain Questionnaire
Interventions
DRUGDexamethasone
DRUGPlacebo
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* English Speaking * Non-laboring women * Scheduled Elective Cesarean section under spinal anesthesia * American Society of Anesthesiologists I-II physical status
Exclusion criteria
* Contraindications to spinal anesthesia * allergy to study medication * patients with allergy to morphine * patients with uncontrolled hypertension * history of peptic ulcer disease * liver cirrhosis * diabetes mellitus * glaucoma * known IV drug abusers * patients with chronic pain or on long term opioids * patients administered steroids in the past week * women with fetuses having known congenital abnormalities * psychiatric illness such that they are unable to comprehend or participate in study questions * patients on antiviral medications or live virus vaccines would also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Analgesia | 24 hours | Comparison of postoperative opioid analgesia use between the 2 groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | 24 hours | Pain 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 |
| Quality of Recovery | 48 hours | 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 |
| Incidence and Severity of Nausea and Pruritus | 24 hours | Patients 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Chronic Pain After Cesarean Delivery | 6 months | Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone & Spinal Morphine intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively
Dexamethasone | 26 |
| 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 | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Dexamethasone & Spinal Morphine | Placebo Injection and Spinal Morphine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 26 Participants | 52 Participants |
| Age, Continuous | 31.69 Years STANDARD_DEVIATION 4.02 | 31.65 Years STANDARD_DEVIATION 5.83 | 31.67 Years STANDARD_DEVIATION 4.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 24 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Postoperative Analgesia
Comparison of postoperative opioid analgesia use between the 2 groups
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone & Spinal Morphine | Postoperative Analgesia | 11.8 milligrams of morphine |
| Placebo Injection and Spinal Morphine | Postoperative Analgesia | 15 milligrams of morphine |
p-value: 0.32Wilcoxon (Mann-Whitney)
Secondary
Incidence and Severity of Nausea and Pruritus
Patients 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)
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus@ 0-6hr | 5 units on a scale |
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus @ 6-12hr | 3 units on a scale |
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @ 0-6hr | 6 units on a scale |
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @12-24hr | 0 units on a scale |
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @ 6-12hr | 0 units on a scale |
| Dexamethasone & Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus @ 12-24hr | 2 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @ 6-12hr | 0 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @ 0-6hr | 2.5 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus@ 0-6hr | 3 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus @ 12-24hr | 1 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Pruritus @ 6-12hr | 0 units on a scale |
| Placebo Injection and Spinal Morphine | Incidence and Severity of Nausea and Pruritus | Nausea @12-24hr | 0 units on a scale |
Secondary
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery
Pain 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
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 0-6hr | 4 units on a scale |
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 0-6hr | 1 units on a scale |
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 12-24hr | 1 units on a scale |
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 6-12hr | 1 units on a scale |
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 12-24hr | 4 units on a scale |
| Dexamethasone & Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 6-12hr | 3 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 12-24hr | 4 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 0-6hr | 1 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 0-6hr | 4.5 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 6-12hr | 2 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain with movement @ 6-12hr | 4 units on a scale |
| Placebo Injection and Spinal Morphine | Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery | Pain at rest @ 12-24hr | 1 units on a scale |
Secondary
Quality of Recovery
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
Time frame: 48 hours
Population: Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone & Spinal Morphine | Quality of Recovery | 180 units on a scale | Standard Deviation 10 |
| Placebo Injection and Spinal Morphine | Quality of Recovery | 177 units on a scale | Standard Deviation 10 |
Other Pre-specified
Number of Participants With Chronic Pain After Cesarean Delivery
Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups
Time frame: 6 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone & Spinal Morphine | Number of Participants With Chronic Pain After Cesarean Delivery | 0 Participants |
| Placebo Injection and Spinal Morphine | Number of Participants With Chronic Pain After Cesarean Delivery | 0 Participants |