Trial Outcomes & Findings for Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section (NCT NCT03098420)

Last Updated: 2021-06-18

Results Overview

Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

29 participants

Primary outcome timeframe

48 hours postoperatively

Results posted on

2021-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	2mg Dexamethasone 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	4mg Dexamethasone 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride
Overall Study STARTED	7	9	13
Overall Study COMPLETED	7	9	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=7 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	2mg Dexamethasone n=9 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	4mg Dexamethasone n=13 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride	Total n=29 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours postoperatively

Outcome measures

Outcome measures
Measure	Control Group n=7 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	2mg Dexamethasone n=9 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	4mg Dexamethasone n=13 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride
Average Pain Score	1.49 units on a scale Standard Deviation 0.25	1.40 units on a scale Standard Deviation 0.40	1.62 units on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: baseline to 48 hrs postoperatively

Time until first dose post-operative opioid administration between the study group and the control

Outcome measures

Outcome measures
Measure	Control Group n=7 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	2mg Dexamethasone n=9 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	4mg Dexamethasone n=13 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride
First Post-Operative Opioid Administration	22.43 Hours Standard Deviation 4.87	12.56 Hours Standard Deviation 3.58	18.25 Hours Standard Deviation 4.23

SECONDARY outcome

Timeframe: from the time of delivery to 48hrs postoperatively

Average opioid consumption 48 hrs postoperatively between the study group and the control

Outcome measures

Outcome measures
Measure	Control Group n=7 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 1ml: 1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	2mg Dexamethasone n=9 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. 2mg Dexamethasone: 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride Normal saline 0.5ml: 0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine	4mg Dexamethasone n=13 Participants 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. 4mg Dexamethasone: 1 mL (4mg) of dexamethasone Ropivacaine (TAP blocks): 20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine Morphine Bupivacaine Hydrochloride
Average Opioid Consumption	37.93 mg of morphine equivalents Standard Deviation 13.50	47.11 mg of morphine equivalents Standard Deviation 12.44	42.38 mg of morphine equivalents Standard Deviation 9.17

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2mg Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4mg Dexamethasone

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. Joel Feinstein

University of Alabama at Birmingham

Phone: 205-934-4696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place