Trial Outcomes & Findings for The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery (NCT NCT01516268)

NCT ID: NCT01516268

Last Updated: 2013-03-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 24 h
• Results posted on: 2013-03-27

Participant Flow

recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center

Exclusions were based on exclusion criteria previously mentioned.

Participant milestones

Measure	Sufentanyl Group IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block	Control Group In control group we add 1cc salin to 20cc bupivacain in TAP block
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane Block to Reduce the Narcotic Dosage and Pain After Cesarean Delivery

Baseline characteristics by cohort

Measure	Sufentanyl Group n=25 Participants IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block	Control Group n=25 Participants In control group we add 1cc salin to 20cc bupivacain in TAP block	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	28.9 years STANDARD_DEVIATION 3.4 • n=5 Participants	29.9 years STANDARD_DEVIATION 5.6 • n=7 Participants	29.1 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 h

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: over 24 hours after surgery

The total dosage of morphin consumed by the patients in sufentanil or control group.

Outcome measures

Measure	Sufentanyl Group n=25 Participants IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block	Control Group n=25 Participants In control group we add 1cc salin to 20cc bupivacain in TAP block
Narcotic Dosage	37.2 mgm,. Standard Deviation 16.15	52.8 mgm,. Standard Deviation 16.7

SECONDARY outcome

Timeframe: 24h

Outcome measures

Outcome data not reported

Adverse Events

Sufentanyl Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sufentanyl Group n=25 participants at risk IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block	Control Group n=25 participants at risk In control group we add 1cc salin to 20cc bupivacain in TAP block
Gastrointestinal disorders Nausea and vomiting	4.0% 1/25 • Number of events 1 • 24h	12.0% 3/25 • Number of events 3 • 24h
Skin and subcutaneous tissue disorders itching	0.00% 0/25 • 24h	4.0% 1/25 • Number of events 1 • 24h

Other adverse events

Measure	Sufentanyl Group n=25 participants at risk IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block	Control Group n=25 participants at risk In control group we add 1cc salin to 20cc bupivacain in TAP block
Skin and subcutaneous tissue disorders itching	0.00% 0/25 • 24h	4.0% 1/25 • Number of events 1 • 24h

Additional Information

Dr. Laleh Eslamian

Tehran University of Medical Sciences

Phone: 0098218490

Email: leslamian@tums.ac.ir

Results disclosure agreements

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