A study to compare the effect of Morphine (an opioid) versus Butorphanol ( an opioid) in surgeries below umbilicus performed under anesthesia

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/05/033800
• Lead Sponsor: Office of Principal Midnapore Medical College and Hospital

Brief Summary

A PROSPECTIVE RANDOMIZED DOUBLE BLINDED STUDY TO COMPARE THE EFFECT OF INTRATHECAL MORPHINE VERSUS INTRATHECAL BUTORPHANOL IN INFRAUMBILICAL SURGERIES PERFORMED UNDER SUBARACHNOID BLOCK.

The objectives are to compare intrathecal preservative-free Morphine and Butorphanol for- perioperative analgesia, sensory and motor blockade, surgical relaxation, respiratory depression and other side effects.

This study is a hospital based prospective randomised double blind clinical study to be performed on cohort of patients posted for elective infra-umbilical surgeries under subarachnoid block in General Surgery operation theatre complexes of Midnapore Medical College and Hospital including PACU as well as wards.

Both Morphine and Butorphanol are expected to provide adequate intraoperative and postoperative analgesia, maintain intraoperative hemodynamics, and provide adequate surgical relaxation while having minimal side effects. At the onset of this trial, it is not possible to predict any better outcome amongst the two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-06
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

CASES WITH ASA GRADE I AND II CASES WITH HEIGHT BETWEEN 150 TO 180 CMS AND BODY WEIGHT BETWEEN 50 TO 80 KG, BMI BETWEEN 18.5 AND 24.9 CASES UNDERGOING INFRAUMBILICAL SURGERY THAT ARE PERFORMED UNDER SUBARACHNOID BLOCK.

Exclusion Criteria

CASES WHICH HAVE CONTRAINDICATION FOR SPINAL ANESTHESIA CASES WITH ASA GRADE III AND ABOVE PREGNANT AND LACTATING PATIENTS PATIENTS WITH PSYCHIATRIC ILLNESS CASES WITH HISTORY OF HYPERSENSITIVITY OR ALLERGY TO STUDY DRUGS CASES WITH NEUROPATHY OR NEUROLOGICAL DISORDER PATIENTS WITH ANY ONGOING THERAPIES WITH SUSTAINED RELEASE OPIOIDS ANY PATIENT WITH CARDIORESPIRATORY OR HEPATORENAL DISORDERS IMMUNOCOMPROMISED AND DIABETIC PATIENTS ANY PATIENT REQUIRING ANALGESIC OR ANESTHETIC SUPPLEMENTATION INTRAOPERATIVELY ANY PATIENT CONVERTED TO GENERAL ANESTHESIA ANYTIME AFTER GIVING SPINAL ANESTHESIA , TILL COMPLETION OF SURGERY ANY UNFORESEEN LIFE THREATENING COMPLICATIONS DUE TO SURGERY OCCURING ANYTIME PERIOPERATIVELY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO ASSESS THE DURATION OF ANALGESIA OF MORPHINE AND BUTORPHANOL INTRAOPERATIVELY AND POSTOPERATIVELY UPTO 12 HOURS	TO ASSESS THE DURATION OF ANALGESIA OF MORPHINE AND BUTORPHANOL INTRAOPERATIVELY AND POSTOPERATIVELY UPTO 12 HOURS

Secondary Outcome Measures

Name	Time	Method
1. HEMODYNAMIC PARAMETERS LIKE HEART RATE, SYSTOLIC BLOOD PRESSURE, DIASTOLIC BLOOD PRESSURE, MEAN BLOOD PRESSURE,	PARAMETERS WILL BE NOTED JUST BEFORE ENTERING OT, FOLLOWED BYEVERY 5 MINUTES FOR 30 MINUTES AND 15 MINUTES THEREAFTER TILL COMPLETION OF SURGERY AND FIRST 2 HOURS POSTOPERATIVELY
SURGICAL RELAXATION	ASKED FROM MAIN SURGEON AT END OF SURGICAL CLOSURE
SENSORY AND MOTOR BLOCKADE	BLOCK CHARACTERISTICS WILL BE NOTED TILL SUCCESSFUL INITIATION OF SENSORY AND MOTOR BLOCK AND EVERY 15 MINUTES AFTER SURGERY FOR FIRST 2 HOURS AND 30 MINUTES THEREAFTER TILL 12 HOURS POSTOPERATIVELY
SEDATION AND OTHER SIDE EFFECTS	ASSESSED EVERY 15 MINUTES INTRAOPERATIVELY AND AFTER SURGERY FOR FIRST 2 HOURS AND 30 MINUTES THEREAFTER TILL 12 HOURS POSTOPERATIVELY

Trial Locations

Locations (1)

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

MIDNAPORE MEDICAL COLLEGE AND HOSPITAL

🇮🇳Medinipur, WEST BENGAL, India

PALLAVI BANERJEE

Principal investigator

9051387694

banerjee.pallavi25@gmail.com