Study to compare effect of Bupivacaine with Tramadol and Levobupivacaine with Tramadol for pain in below umblical surgeries after operation by epidural catheter.

Not yet recruiting

• Registration Number: CTRI/2023/04/051462
• Lead Sponsor: Peoples University,bhopal,madhya pradesh

Brief Summary

POST OPERATIVE PAIN AFTER MAJOR INFRAUMBLICAL SURGERIES IS THE MAINSTAY OF CONCERN ,AS IT CAN INCREASE RISK OF RESPIRATORY & CARDIOVASCULAR COMPLICATIONS AND GASTROINTESTINAL MOTILITY ,AMBULATION & HOSPITAL STAY.EPIDURAL ANALGESIA CAN PROVIDE EXCELLENT POST OPERATIVE ANALGESIA.

VARIOUS STUDIES HAVE FOUND THAT DIFFERENT LOCAL ANAESTHETIC CAN PROVIDE ANALGESIA.WE ARE COMPARING EFFECT OF BUPIVACAINE WITH TRAMADOL & LEVOBUPIVACAINE WITH TRAMADOL AS THEY ARE HAVING LOW SIDE EFFECT PROFILE &CAN PROVIDE EXCELLENT POST OPERATIVE ANALGESIC EEFECT FOR FIRST 24 HOURS POST OPERATIVELY IN INFRAUMBLICAL SURGERIES.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-15
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ASA GRADE 1& 2 SCHEDULE FOR ELECTIVE IN BELOW UMBILICAL SURGERIES THAT REQUIRE POST OPERATIVE EPIDURAL ANALGESIA.
• DOSE OF INJ.BUPIVACAINE 3.5ML WITHOUT ADJUVANT.
• DURATION OF SURGERY 90-120 MINS.

Exclusion Criteria

• LACK OF PATIENTS CONSENT.
• AGE <18YRS & >60YRS.
• ASA GRADE 3 AND MORE.
• HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION,CORONARY ARTERY OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE.
• PATIENTS WITH LOCAL SKIN INFECTIONS.
• PATIENTS WITH HYPERSENSITIVITY TO ANY OF THE DRUGS USED.
• PREGNANT AND LACTATING MOTHERS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO COMPARE NUMBER OF EPIDURAL ANALGESIA (top up) required in first 24 hours in both groups.	FIRST 24 HOURS AFTER THE SURGERY

Secondary Outcome Measures

Name	Time	Method
TO COMPARE HEMODYNAMIC CHNAGES IN THE POST OPRETIVE PERIOD.	FIRST 24 HOURS AFTER THE SURGERY

Trial Locations

Locations (1)

PEOPLES COLLEGE OF MEDICAL SCIENCES BHOPAL; 🇮🇳 Bhopal, MADHYA PRADESH, India

PEOPLES COLLEGE OF MEDICAL SCIENCES BHOPAL

🇮🇳Bhopal, MADHYA PRADESH, India

DR ANKIT GUPTA

Principal investigator

9993007222

ankit.gupta37@gmail.com