A research to study the efficacy of a procedure, ultrasound guided infiltration of a local anaesthetic in abdominal muscles for providing postoperative pain relief in patient who are undergoing delivery by Caesarean Section

Completed

• Conditions: Patients who are undergoing Caesarean Section under Spinal Anaesthesia

• Registration Number: CTRI/2010/091/001488
• Lead Sponsor: NOT APPLICABLE

Brief Summary

This is a randomized, double blinded, parellel group placebo controlled study to see the efficacy of Ultrasound guided Transversus abdominis Block in patients undergoing caesarean section under spinal anaesthesia to be conducted at Max Superspeciality hospital, Saket over a period of eight months. The Primary outcome measure will be the amount of Fentanyl required in 24 hrs postoperatively. The secondary outcome measures will be mean Visual Analogue scale at the end of 12hrs and 24hrs postoperatively, mean Ramsay Sedation Score at the end of 24hrs and any complications or side effects arising due to Transversus abdominis Plane Block or due to Patient Controlled Analgesia Fentanyl infusion postoperative period in the initial 24 hrs.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-14
• Last Update Posted: 2013-08-03

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Adult females of all Racial and Ethnic Group of child bearing age group undergoing Caesarean section under Spinal Anaesthesia with American Society of Anaesthesiology (ASA) Criteria I, IE(Emergency), II and IIE.

Exclusion Criteria

Patient with history of Chronic Obstructive Pulmonary Disease, Asthma, allergic reaction to Local Aanesthetic, opioid dependence.Patients with coagulopathy,Pre-eclampsia/eclampsia.Patients in whom adjuvent analgesia like Paracetamol and Diclofenac is contraindicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement of Fentanyl	24Hrs

Secondary Outcome Measures

Name	Time	Method
Mean Ramsay Sedation Score	over 24 Hrs postoperatively
Mean Visual Analogue Score	at the end of 12 Hrs, and 24Hrs postoperatively
Any other complication related to Transversus Abdominis Plane Block or Intravenous PCA Fentanyl	Over 24 hrs after the procedure

Trial Locations

Locations (1)

Max Superspeciality Hospital; 1,Press Enclave Road; Saket; New Delhi - 110017; 🇮🇳 Delhi, DELHI, India

Max Superspeciality Hospital; 1,Press Enclave Road; Saket; New Delhi - 110017

🇮🇳Delhi, DELHI, India

Dr. Om Prakash

Principal investigator

9910300237

dromprakas@gmail.com