A COMPARISON BETWEEN TWO GROUPS WITH 0.5% BUPIVACAINE(LOCAL ANESTHETIC AGENT) AND 0.5% BUPIVACAINE WITH PENTAZOCINE,AN OPIOID ANALGESIC, AS AN ADDITIVE FOR POST OPERATIVE PAIN RELIEF IN UPPER LIMB SURGERY BY SUPRACLAVICULAR BRACHIAL PLEXUS NERVE BLOCK WHICH BLOCKS NERVE SUPPLY OF UPPER LIMB

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/07/026494
• Lead Sponsor: MIDNAPORE MEDICAL COLLEGE AND HOSPITAL

Brief Summary

Aprospective,randomised,double blinded comparative study between 0.5%bupivacaine and 0.5% bupivacaine with pentazocine as an adjuvant insupraclavicular brachial plexus block for post operative analgesia in upperlimb surgery

Our objective is tocompare the intraoperative effect , hemodynamic stability and post operativeanalgesia duration  and side effects between 0.5% bupivacaine and0.5% bupivacaine with pentazocine as an adjuvent in supraclavicular brachialplexus block .

This is a hospital based,prospective, randomized, placebo-controlled, double blind,analytical  study on cohort of patients posted for elective upperlimb surgery under supra clavicular brachial plexus block in general surgeryand orthopedics operation theatre and PACU of Midnapore Medical College overthe period of 18 months

We are expecting that 0.5%bupivacaine with pentazocine as an adjuvant will increase duration of sensoryand motor blockade and will provide better analgesia than 0.5% bupivacaine alone on 70 patient posted for upper limb surgery .

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age between 18-60 years 2.
• ASA grade 1 & 2 3.
• Elective upper limb Surgery under supraclavicular brachial plexus block.

Exclusion Criteria

• Patients with history of Uncontrolled Diabetes-Mellitus Uncontrolled Hypertension Coagulopathy Liver disease Cardio pulmonary disease Renal insufficiency or failure Musculoskeletal disorder Drug and alcohol abuse 2.
• Pregnant patients 3.
• BMI more than 30 4.
• Allergy to bupivacaine or pentazocine 5.
• Conversion to general anesthesia 7.
• Brachial plexus block failure 8.
• Difficult airway 9.
• Surgeries with intraoperative time more than 2 hours.
• Patient who received analgesic in the pre operative phase (within effective time range of that particular drug) 11.
• Unwilling to participate 12.
• Serology positive (HIV1&2,Hbs ag,Anti HCV), & immunocompromised patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We are expecting that 0.5% bupivacaine with pentazocine as an adjuvant will increase duration of sensory and motor blockade and will provide better analgesia than 0.5% bupivacaine alone	Patient’s hemodynamic profile (like BP, heart rate, oxygen saturation etc), pain , and adverse effects will be monitored at base line, just after giving block then every 15 minutes intra operatively and every hour postoperatively for 8 hours.

Secondary Outcome Measures

Name	Time	Method
1.To compare the hemodynamic changes like Heart rate(HR), Systolic Blood Pressure(SBP),	Diastolic Blood Pressure(DBP),Mean Arterial Pressure(MAP) intra and post operatively

Trial Locations

Locations (1)

MIDNAPORE MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Medinipur, WEST BENGAL, India

MIDNAPORE MEDICAL COLLEGE AND HOSPITAL

🇮🇳Medinipur, WEST BENGAL, India

DEBMALYA MUKHERJEE

Principal investigator

9434474471

debmalyamukherjee1@gmail.com