| CTRI Number |
CTRI/2021/05/033800 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
24/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Morphine (an opioid) versus Butorphanol ( an opioid) in surgeries below umbilicus performed under anesthesia |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMIZED DOUBLE BLINDED STUDY TO COMPARE THE EFFECT OF INTRATHECAL MORPHINE VERSUS INTRATHECAL BUTORPHANOL IN INFRAUMBILICAL SURGERIES PERFORMED UNDER SUBARACHNOID BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PALLAVI BANERJEE |
| Designation |
POST GRADUATE TRAINEE MD ANESTHESIOLOGY |
| Affiliation |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL, VIDYASAGAR ROAD, MIDNAPORE,PASCHIM MEDINIPORE-721101,WEST BENGAL,INDIA
Medinipur
WEST BENGAL
721101
India |
| Phone |
9051387694 |
| Fax |
|
| Email |
banerjee.pallavi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMAN CHATTOPADHYAY |
| Designation |
PROFESSOR HEAD OF DEPARTMENT, DEPARTMENT OF ANESTHESIOLOGY,MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Affiliation |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL, VIDYASAGAR ROAD, MIDNAPORE,PASCHIM MEDINIPORE-721101,WEST BENGAL,INDIA
Medinipur
WEST BENGAL
721102
India |
| Phone |
9830234881 |
| Fax |
|
| Email |
sumanc24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEBALEENA JANA |
| Designation |
ASSISTANT PROFESSOR,DEPARTMENT OF ANESTHESIOLOGY,MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Affiliation |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL, VIDYASAGAR ROAD, MIDNAPORE,PASCHIM MEDINIPORE-721101,WEST BENGAL,INDIA
Medinipur
WEST BENGAL
721101
India |
| Phone |
9477038017 |
| Fax |
|
| Email |
licimed@gmail.com |
|
|
Source of Monetary or Material Support
|
| OFFICE OF PRINCIPAL MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
|
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Primary Sponsor
|
| Name |
Office of Principal Midnapore Medical College and Hospital |
| Address |
Midnapore Medical college and Hospital, Vidyasagar road, Midnapore,Paschim Medinipur-721101,West Bengal ,India |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PALLAVI BANERJEE |
MIDNAPORE MEDICAL COLLEGE AND HOSPITAL |
Surgery and Gynaecological operating theatre complexes, Post anesthesia care unit, and surgical and gynaecological wards
Medinipur
WEST BENGAL |
9051387694
banerjee.pallavi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF MMCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTRATHECAL BUTORPHANOL FOR PERIOPERATIVE ANALGESIA,EFFECT ON HEMODYNAMIC PARAMETERS,SENSORY AND MOTOR BLOCKADE, DEGREE OF SURGICAL RELAXATION,AND OTHER SIDE EFFECTS |
0.25 mg BUTORPHANOL ADMINISTERED WITH 3.5 ML OF LEVOBUPIVACAINE INTRATHECALLY DURING SUBARACHNOID BLOCK
|
| Comparator Agent |
INTRATHECAL MORPHINE FOR PERIOPERATIVE ANALGESIA,EFFECT ON HEMODYNAMIC PARAMETERS,SENSORY AND MOTOR BLOCKADE, DEGREE OF SURGICAL RELAXATION,AND OTHER SIDE EFFECTS |
0.15 mg MORPHINE ADMINISTERED WITH 3.5 ML OF LEVOBUPIVACAINE INTRATHECALLY DURING SUBARACHNOID BLOCK |
| Intervention |
TO COMPARE THE EFFECT OF INTRATHECAL MORPHINE VERSUS INTRATHECAL BUTORPHANOL IN INFRA-UMBILICAL SURGERIES PERFORMED UNDER SUBARACHNOID BLOCK. |
0.15 mg MORPHINE ADMINISTERED WITH 3.5 ML OF LEVOBUPIVACAINE INTRATHECALLY DURING SUBARACHNOID BLOCK IN ONE GROUP OF PATIENTS
0.25 mg BUTORPHANOL ADMINISTERED WITH 3.5 ML OF LEVOBUPIVACAINE INTRATHECALLY DURING SUBARACHNOID BLOCK IN SECOND GROUP OF PATIENTS
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
| 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 |
| SURGICAL RELAXATION |
ASKED FROM MAIN SURGEON AT END OF SURGICAL CLOSURE |
| 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 |
|
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Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO PUBLICATION YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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.
|