A comparative study of nalbuphine and fentanyl as additives to bupivacaine in spinal anaesthesia in patients undergoing TURP surgery

Phase 1/2

Completed

• Conditions: Benign prostatic hyperplasia withlower urinary tract symptoms,

• Registration Number: CTRI/2019/09/021013
• Lead Sponsor: department of anaesthesia dayanand medical college and hospital

Brief Summary

THIS STUDY WAS CONDUCTED IN RANDOMIZED, DOUBLE CONTROLLED MANNER ON A TOTAL OF 60 ASA GRADE I & II PATIENTS POSTED FOR TURP SURGERY UNDER SUBARACHANOID BLOCK USING BUPIVACAINE AS THE LOCAL ANAESTHETIC DRUG. THE DRUGS FENTANYL AND NALBUPHINE WERE USED AS ADJUVANTS TO BUPIVACAINE FOR COMPARATIVE EVALUATION OF EACH IN TERMS OF ONSET AND DURATION OF MOTOR AND SENSORY BLOCK AND CHANGES IN HAEMODYNAMIC PARAMETERS INTRAOPERATIVELY AS WELL AS POSTOPERATIVELY. ALSO, THE POSTOPERATIVE ANALGESIA AND SIDE EFFECT PROFILE IN BOTH THE GROUPS WERE RECORDED. ALL THE OBSERVATIONS WERE TABULATED AND SENT FOR STATISTICAL EVALUATION.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Study Completion: 2017-03-20
• Last Update Posted: 2019-08-27

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

ASA grade I and II.

Exclusion Criteria

• ASA grade III or more 2.
• Patients refusal for subarachnoid block.
• Patients on anticoagulant medication.
• History of anaphylaxis to local anaesthetics.
• Infection at site of injection.
• patient with spinal deformities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. onset and duration of sensory block level.	onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
2. onset and duration of motor block level.	onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.
3. evaluating haemodynamic parameters.	onset of sensory and motor block level and haemodynamic parameters to be evaluated every 5 minutes for first 15 minutes and then every 15 minutes for 90 minutes intraoperatively. Duration of sensory and motor block assessed for the next 6hours and hemodynamic paramerters for the next 24 hours in the postoperative period.

Secondary Outcome Measures

Name	Time	Method
1. Duration of post operative analgesia.	2. Side effect profile with each drug.

Trial Locations

Locations (1)

DAYANAND MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Ludhiana, PUNJAB, India

DAYANAND MEDICAL COLLEGE AND HOSPITAL

🇮🇳Ludhiana, PUNJAB, India

palavi garg

Principal investigator

9888530401

garg_palavi88@yahoo.co.in