A clinical trail effects of the drug magnesium sulfate over pain after surgery in patients undergoing surgery around anus when it is added to local anaesthetic solution in wound infiltration after the surgery

Not yet recruiting

• Conditions: Anal fistula, (2) ICD-10 Condition: K601||Chronic anal fissure, (3) ICD-10 Condition: K601||Chronic anal fissure, (4) ICD-10 Condition: K641||Second degree hemorrhoids, (5) ICD-10 Condition: K642||Third degree hemorrhoids,

• Registration Number: CTRI/2021/05/033570
• Lead Sponsor: NAGALINGAM N

Brief Summary

50 patients undergoing perianal surgeries are selected  and will be dividied into 2 groupsof 25 each. Informed consent will be obtained. Surgery will bedone under spinal anaesthesia using 2 ml 0.5%hyperbaric Bupivacaine. At the end of surgery, wound infiltration will be done inall patients.

Group A will receive15ml 0.5% bupivacaine and 1 ml saline

Group B will receive15ml 0.5% bupivacaine and 100 µg of mgso4

Surgeries ended up in complications will be removed fromthe study. Data will be collected and processed for analysis

Studyvariables and their measurement: General parameters i.e. Age,Gender, BMI, Duration of surgery and duration ofspinal blockade, vitals will be observed every 30 min till first 2 hrs, at 6,12, 18 and 24 hr. Pain score at rest and on movement using Visual Analoguescale (VAS) 0-10 assessed every 2 hrs from the end of surgery till 24 hrs, incidence of postoperative nausea and vomiting, time of mobilisation, pain score at the time of defacation, parenteral analgesic requirements in 24 hrs period. Inj. Tramadol 50 mg IV was used as rescue analgesic when VAS score reaches 4 and duration of postoperative analgesia is measured as time whenVAS first reaches 4.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-15
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

ASA I & II patients of Age 18-50 years of both gender with normal range of BMI undergoing Perianal surgeries like fissure in ano, fistula in ano and haemorrhoidectomy.

Exclusion Criteria

ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Addition of magnesium sulfate to local anaesthetic solution prolongs the postoperative analgesia.	24 hours

Secondary Outcome Measures

Name	Time	Method
Addition of magnesium sulfate to local anaesthetic solution reduces defecation pain and helps in early mobilisation	24 hours

Trial Locations

Locations (1)

Sri Lakshmi Narayan Institute of Medical Sciences; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri Lakshmi Narayan Institute of Medical Sciences

🇮🇳Pondicherry, PONDICHERRY, India

NAGALINGAM N

Principal investigator

9655239900

drnaga2k@gmail.com