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A clinical trial to compare two different doses of magnesium sulfate as an adjuvant to bupivacaine in transversus abdominis plane block for postoperative analgesia in caesarean section.

A comparative evaluation of two different doses of magnesium sulfate as an adjuvant to bupivacaine in transversus abdominis plane block for postoperative analgesia in caesarean section: A randomized, double-blind, superiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052058
Enrollment
112
Registered
2023-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 1- Obstetrics Health Condition 2: O268- Other specified pregnancy relatedconditions

Interventions

Intervention1: MgSO4-200 mg both side: Group A ? Patients will receive 20 ml 0.25% Bupivacaine + 200 mg (0.4 ml of MgSO4 50 %) Magnesium sulphate +1.6 ml NS on each side Immediately after completio

Sponsors

DrVijeta Bajpai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 18 - 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

Exclusion criteria: 1 Age 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

Design outcomes

Primary

MeasureTime frame
To assess superiority of the mean duration of analgesia in patients who received magnesium sulphate 500 mg as an adjuvant with bupivacaine as compared to magnesium sulphate 200 mg in ultrasound guided Transversus Abdominus Plane (TAP) block for postoperative analgesia following Caesarean delivery. Timepoint: post op -24 hours

Secondary

MeasureTime frame
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 2- Total mean opioid consumption in first 24 hours following Caesarean delivery in both study groups 3- Haemodynamic parameters in both study groups 4- Satisfaction score in both study groups. Safety outcome- Recording and reporting of adverse events(nausea, vomiting, prurutis, respiratory depression) will be collected. Timepoint: post op -24 hours

Countries

India

Contacts

Public ContactDrVijeta Bajpai

All India Institute of Medical Sciences Gorakhpur

drvijeta86gsvm@gmail.com9918724600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026