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.

Comparison of efficacy and safety of magnesium sulphate and dexmedetomidine in ultrasound guided transversus abdominus plane (TAP) block for postoperative analgesia after Caesarean section:A randomised ,double blind ,non inferiority study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051983

Enrollment

Registered

2023-04-26

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: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Group MB: 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 completion of surgery. Control

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

Measure	Time frame
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 deliveryTimepoint: 0-24 hours post operative period	—

Secondary

Measure	Time 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: 0-24 hour post operative period	—

Measure

Time 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: 0-24 hour post operative period

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Countries

India

Contacts

Public ContactDr Vijeta 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