A clinical trial to study the effect and safety of magnesium sulphate and dexmedetomidine in ultrasound guided transversus abdominus plane (TAP) block for postoperative analgesia after Caesarean section.

Phase 4

Not yet recruiting

• Conditions: Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2023/04/051983
• Lead Sponsor: DrVijeta Bajpai

Brief Summary

This study is a randomized, double blind, parallel group, comparing

the efficacy and safety of adding Magnesium sulphate or Dexmedetomidine with Bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Cesarean delivery  in 90  patients admitted at AIIMS Gorakhpur for elective or  emergency Cesarean delivery . The primary outcome measures will be to assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery. Secondary

outcomes are to compare mean or median postoperative pain scores at rest and on coughing during first 24 hours ,total mean opioid consumption in first 24 hours, haemodynamic parameters and Satisfaction score in both study groups .Safety outcome will be Recording and reporting of adverse events.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-25
• Study Start: 2023-05-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

35 years females belonging to the American Society of Anesthesiologists (ASA) Class I/II 2 Elective or Emergency LSCS under Subarachnoid block. 3 Normal bleeding profile. 4 No history of relevant drug allergy. 5 Patients willing to participate in the study.

Exclusion Criteria

• 1 Age <18 and >35 years.
• 2 Patient refusal.
• 3 Significant cardiovascular disease, hepatic dysfunction or renal dysfunction 4 Coagulation abnormalities and Bleeding disorder 5 Infection in the intended intervention site 6 Patient on intravenous MgSO4 7 Eclamptic or preeclamptic patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess non-inferiority of the mean duration of analgesia in patients who received magnesium sulphate and Dexmedetomidine as an adjuvant with bupivacaine in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery	0-24 hours post operative period

Secondary Outcome Measures

Name	Time	Method
1 To compare mean or median postoperative pain scores at rest and on coughing during first 24 hours	(immediately after block, 30 min, 1 h, 2h, 4h, 8h, 12h and 24 h) following Caesarean delivery in both study groups

Trial Locations

Locations (1)

All India Institute of Medical Sciences,Gorakhpur; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

All India Institute of Medical Sciences,Gorakhpur

🇮🇳Gorakhpur, UTTAR PRADESH, India

Dr Vijeta Bajpai

Principal investigator

9918724600

drvijeta86gsvm@gmail.com