Trial Outcomes & Findings for Dexamethasone for Post-cesarean Delivery Pain (NCT NCT01812057)

NCT ID: NCT01812057

Last Updated: 2017-07-25

Results Overview

The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: 24 hours from admission to Postanesthesia care unit (PACU)
• Results posted on: 2017-07-25

Participant Flow

Of the 52 subjects that were enrolled, 3 subjects were not randomized due to later being deemed ineligible for the study; therefore, 49 subjects started on study.

Participant milestones

Measure	Dexamethasone Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Overall Study STARTED	25	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Dexamethasone Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

Dexamethasone for Post-cesarean Delivery Pain

Baseline characteristics by cohort

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml	Total n=47 Participants Total of all reporting groups
Age, Continuous	32.2 years STANDARD_DEVIATION 4.7 • n=5 Participants	30.63 years STANDARD_DEVIATION 5.71 • n=7 Participants	31.40 years STANDARD_DEVIATION 5.23 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Caucasian	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian/Indian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours from admission to Postanesthesia care unit (PACU)

The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Morphine Consumption at 24 Hours Post-op	15 milligram Interval 7.5 to 20.0	13.75 milligram Interval 2.5 to 31.25

SECONDARY outcome

Timeframe: 2 hours from admission to postanesthesia care unit (PACU)

Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Pain Scores Between the Groups at 2 Hours. Pain Score at rest	2 units on a scale Interval 0.0 to 4.0	3.5 units on a scale Interval 1.5 to 5.0
Pain Scores Between the Groups at 2 Hours. Pain Score with movement	5 units on a scale Interval 2.0 to 7.0	5 units on a scale Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: PACU admission to discharge from PACU an average of 2 hours

Population: Analysis was based on all 47 patients who completed the study.

Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Time to Administration of First Rescue Analgesic Request Between the Groups.	52.5 minutes Interval 22.5 to 88.5	70 minutes Interval 30.0 to 112.0

SECONDARY outcome

Timeframe: Admission to PACU through 48 hours

The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Cumulative Opioid Consumption at 48 Hours Between the Groups	20 milligrams Interval 10.0 to 40.0	22.5 milligrams Interval 3.75 to 48.75

SECONDARY outcome

Timeframe: 24 hours from PACU admission

Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Pain Scores Between the Groups at 24 Hours. Pain Score at rest	2 units on a scale Interval 0.0 to 3.0	2.5 units on a scale Interval 1.0 to 4.25
Pain Scores Between the Groups at 24 Hours. Pain Score with movement	5 units on a scale Interval 3.0 to 7.0	5 units on a scale Interval 4.0 to 6.75

SECONDARY outcome

Timeframe: 48 hours from PACU Admission

Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Pain Scores Between the Groups at 48 Hours. Pain Score at rest	2.0 units on a scale Interval 0.0 to 3.0	2.0 units on a scale Interval 0.0 to 4.0
Pain Scores Between the Groups at 48 Hours. Pain Score with movement	4.0 units on a scale Interval 3.0 to 6.0	5.0 units on a scale Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 24 hours from admission to Postanesthesia care unit (PACU)

Population: Analysis was based on all 47 patients who completed the study.

Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.

Outcome measures

Measure	Dexamethasone n=9 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=38 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Cumulative Opioid Consumption at 24 Hours Between MTS Groups	17.5 milligrams Interval 7.5 to 32.5	15 milligrams Interval 2.5 to 25.0

SECONDARY outcome

Timeframe: 8 weeks from the day of surgery

Population: Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.

Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery

Outcome measures

Measure	Dexamethasone n=10 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=16 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Chronic Persistent Pain at 8 Weeks	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months from the day of surgery

Population: Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.

Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery

Outcome measures

Measure	Dexamethasone n=12 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=13 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Chronic Persistent Pain at 6 Months	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours after PACU admission

Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.

Outcome measures

Measure	Dexamethasone n=9 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=38 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Pain Scores Between MTS Groups Pain scores at rest at 24 hours	2.0 units on a scale Interval 1.0 to 4.0	2.0 units on a scale Interval 2.0 to 4.0
Pain Scores Between MTS Groups Pains scores on movement at 24 hours	5.0 units on a scale Interval 3.0 to 7.0	4.0 units on a scale Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: From spinal anesthesia placement to end of surgery, approximately 70 minutes

Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. Incidence of intraoperative nausea	5 Participants	2 Participants
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. Intraoperative need for rescue antiemetic	10 Participants	9 Participants
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. Incidence of intraoperative vomiting	4 Participants	5 Participants

SECONDARY outcome

Timeframe: From spinal anesthesia placement to end of surgery, approximately 70 minutes

Population: No data was collected on intraoperative pruritus on any participants.

pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours from admission to PACU

Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.

If median score >0 then patient experienced postoperative pruritus.

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Postoperative Pruritus	16 Participants	17 Participants

SECONDARY outcome

Timeframe: From spinal anesthesia placement to end of surgery, approximately 70 minutes

Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Need for Intraoperative Analgesic Supplementation	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 2, 24 and 48 hours from PACU admission

Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.

Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics Incidence of PONV at 24 hours	9 Participants	13 Participants
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics Postoperative need for rescue antiemetics	10 Participants	18 Participants
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics Incidence of PONV at 48 hours	1 Participants	2 Participants
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics Incidence of PONV at 2 h	9 Participants	14 Participants

SECONDARY outcome

Timeframe: 24 hours from PACU admission

Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery

Outcome measures

Measure	Dexamethasone n=23 Participants Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Dexamethasone: Dexamethasone 8 mg IV (as a one time dose)	Placebo n=24 Participants Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Placebo: Sodium Chloride 0.9% -5 ml
Incidence of Wound Complications	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Intraoperatively

Population: No data was collected intraoperatively using CNAP on any participants.

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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 Terrence K Allen

Duke University Medical Center

Phone: 9196682024

Email: terrence.allen@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place