Transverse Abdominal Block for Analgesia in Casarean Section

Not Applicable

Completed

• Conditions: Analgesia Disorder
• Interventions: Drug: Bupivacine group; Drug: Dexmedetomidine

• Registration Number: NCT02122510
• Lead Sponsor: Tanta University

Brief Summary

In this study, the investigators will compare the analgesic effect of bupivacaine and bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP block, on the patients for whom the operation will be performed under general anesthesia.

Detailed Description

The investigators will study 60 ASA \[American Society of Anesthesiologist\] physical status I and ІІ patients undergoing elective cesarean delivery at tanta University Hospital, in a prospective, randomized, comparative, clinical trial.

Patients will be randomly allocated to two equal groups (n = 30) using closed envelopes labeled 1,and 2 reflecting group 1and 2 respectively.

The drugs are prepared by the anesthesiologist who is not involved in the study or data collection.

Group I: (n=30) will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.

Group II: (n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G2.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-14
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. We will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery
2. Age between 21-40 years old.

Exclusion Criteria

1. Refusal of participation in the study
2. Patients who have infection or tumor at the site of puncture for local anesthetic injection.
3. Patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs.
4. Patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine
5. Severe hepatic and/or renal insufficiency
6. Morbid obesity (body mass index (BMI) >35)
7. Psychological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine group	Bupivacine group	Bupivacaine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G 2.
dexmetomedine group	Dexmedetomidine	dexmetomedine group will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2.

Primary Outcome Measures

Name	Time	Method
hemodynamic changes	2 hours	blood pressure and heart rate measured every 15 minutes during the intraopertive peroid

Secondary Outcome Measures

Name	Time	Method
Analgesic requirements	24 hours	VAS will be measured during 24 hours after surgery every 4 hours

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Algharbiya, Egypt