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

Pain Clinical Trial

— TAP  

Official title:

the Effect of Adding Sufentanyl to Bupivacaine in Transversus Abdominis Plane (TAP) Block Under the Guide of Ultrasound to Reduce the Narcotic Dosage, Side Effects and Pain in the First 24 Hours After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516268
• Other study ID #: 886
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2012
• Last updated: February 19, 2013
• Start date: January 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Health ministry of Iran:Iran
• Study type: Interventional

Clinical Trial Summary

Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• female 18 to 40 Years

• class ASA 1 and 2

• candidates for elective cesarean section

Exclusion Criteria:

• renal failure

• liver failure

• cardiac disorder

• coagulopathy

• hepatomegaly

• splenomegaly

• drug sensitivity and abuse

• morbid obesity

• smoking

• history of post operative nausea and vomiting

• motion sickness

• local hypoesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Sufentanyl
As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block. As comparator 1cc normal saline is added to bupivacain in control group for Tap block.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati hospital, TUMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Dosage		24 h	Yes
Primary	Narcotic Dosage	The total dosage of morphin consumed by the patients in sufentanil or control group.	over 24 hours after surgery	Yes
Secondary	Pain		24h	No