A study to see if adding magnesium sulphate to local anaesthetic in abdominal block decreases pain after gall bladder surgery

Phase 2

Recruiting

• Conditions: Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/12/038916
• Lead Sponsor: Govt SKIMS Medical College Hospital

Brief Summary

The study is a prospective randomised controlled trial to assess the effect  of adding magnesium sulphate  as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block in laproscopic cholecystectomy.The study is planned for 80 patients.The primary outcome measure is post-operative pain during the first 24 hours after surgery using visual analogue scale.Secondary outcome measures are time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours, post-operative nausea and vomiting,sedation,patient satisfaction.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-25
• Study Start: 2022-01-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adult patients aged 18-65 years undergoing laparoscopic cholecystectomy.

Exclusion Criteria

• 1.Patient refusal 2.Patients with a history of cardiac, or respiratory diseases (>ASA III).
• 3.Patients with allergy to amide local anesthetics or medication included in the study.
• 4.Infection at the needle insertion site.
• 5.Pregnancy 6.BMI >35 7.Drug abusers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The post-operative pain during first 24 hours after surgery using Visual analogue scale.	24 hours

Secondary Outcome Measures

Name	Time	Method
1.Time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours	2.Post-operative nausea and vomiting

Trial Locations

Locations (1)

Skims Medical College Hospital Bemina; 🇮🇳 JAMMU, & KASHMIR, India

Skims Medical College Hospital Bemina

🇮🇳JAMMU, & KASHMIR, India

Dr Wasim Mohammad Bhat

Principal investigator

7006868235

wmb914@gmail.com