CTRI Number |
CTRI/2021/10/037339 [Registered on: 14/10/2021] Trial Registered Prospectively |
Last Modified On: |
13/10/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison between morphine and nalbuphine as intrathecal adjuvants to 0.5% hyperbaric bupivacaine for subarachnoid block in lower abdominal surgeries. |
Scientific Title of Study
|
Comparative evaluation of morphine versus nalbuphine as intrathecal adjuvants to 0.5% hyperbaric bupivacaine for subarachnoid block in lower abdominal surgeries: a prospective randomized double blind study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SARAVJOT KAUR SANDHU |
Designation |
JUNIOR RESIDENT |
Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL , JAIPUR |
Address |
DEPARTMENT OF ANAESTHESIOLOGY , GENERAL OT ,
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL
RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN
Jaipur RAJASTHAN 302022 India |
Phone |
8847662441 |
Fax |
|
Email |
sandhusabinaz@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR VIGYA GOYAL |
Designation |
ASSISTANT PROFESSOR |
Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL , JAIPUR |
Address |
DEPARTMENT OF ANAESTHESIOLOGY , GENERAL OT ,
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL
RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN
Jaipur RAJASTHAN 302022 India |
Phone |
8349249511 |
Fax |
|
Email |
goyalvigya@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR DURGA JETHAVA |
Designation |
HEAD OF DEPARTMENT DEPARTMENT OF ANAESTHESIOLOGY |
Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL JAIPUR |
Address |
DEPARTMENT OF ANAESTHESIOLOGY , GENERAL OT ,
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL
RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN
Jaipur RAJASTHAN 302022 India |
Phone |
9680064336 |
Fax |
|
Email |
djethava@gmail.com |
|
Source of Monetary or Material Support
|
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL SITAPURA JAIPUR
|
|
Primary Sponsor
|
Name |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL JAIPUR |
Address |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL RICCO
INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN
Jaipur
RAJASTHAN
302022
India |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR SARAVJOT KAUR SANDHU |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL JAIPUR |
Department of
anaethesia OT
complex Mahatma
Gandhi Medical College
& Hospital RIICO
Institutional Area, Tonk
Rd Sitapura Jaipur
Rajasthan 302022
Jaipur
RAJASTHAN
Jaipur RAJASTHAN |
08847662441
sandhusabinaz@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
OfficeoftheInstitutionalEthicsCommittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N800||Endometriosis of uterus, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (4) ICD-10 Condition: K37||Unspecified appendicitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intrathecal injection of 3ml 0.5 percent hyperbaric bupivacaine with 100 mcg morphine vs 400 mcg nalbuphine for sub arachnoid block lower abdominal abdominal surgeries |
Subarachnoid Block will be performed under strict aseptic conditions in the sitting position at the level of L 3- L4 / L4-L5 intervertebral space using 25G Quincke’s spinal needle. After ensuring free flow of CSF , 3.2 ml of study drug solution will be administered according to group allocation. Patients will be placed in the supine position |
Comparator Agent |
Morphine plus 0.5 % hyperbaric bupivacaine |
3 ml of 0.5 % hyperbaric bupivacaine plus 100 mcg morphine given intrathecally
Total volume of 3.2 ml given |
Comparator Agent |
Nalbuphine plus 0.5 % hyperbaric bupivacaine |
3 ml of 0.5 % hyperbaric bupivacaine plus 400 mcg nalbuphine intrathecally
Total volume of 3.2 ml given |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
American Society of Anaesthesiologists (ASA) I and II patients
Age group of 18-60 years
Patient with written valid consent
Patient undergoing elective lower abdominal surgery.
|
|
ExclusionCriteria |
Details |
Patient refusal
History of allergy to study drug
Morbid obesity.
Failure of spinal blockade.
Bleeding disorders.
Infection at the site.
Anatomic abnormalities
Inability to comprehend or participate in pain scoring system.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To assess and compare the analgesic efficacy of morphine with nalbuphine
To assess and compare time of onset of sensory block
Onset of complete motor blockade
Duration of motor block
To note and compare requirement of supplemental analgesic during surgery To compare intraoperative hemodynamic parameters
|
24 hours
|
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess and compare postoperative visual analogue scale (VAS) score at rest and with movement .
Time to request for first rescue analgesia in both the groups.
Total dose of rescue analgesia required in first 24 hrs.
Incidence of side effects
|
24 hours |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
29/10/2021 |
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="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NONE |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spinal anesthesia is the most frequently used procedure for lower abdominal surgeries as this technique is both easy to administer and very economical. It has the benefit of being cost-effective, easy technique of administration, rapid onset of action, and relatively fewer adverse effects, and most importantly patient remaining aroused throughout the procedure. A postoperative period free from pain and stress definitely helps in early mobilization and recovery, thereby reducing morbidity and mortality. However, due to the short duration of action and early arising post-operative pain the role of various adjuvants has been proposed and evaluated. Post-operative pain and tissue injury associated with surgery initiate a systemic stress response that has neuroendocrine, immunological, and hematological responses. Intrathecal (IT) administration of adjuvants to local anesthetics improves quality and duration of the spinal blockade, prolongs post-operative analgesia and also reduce the dose and amount of local anesthetic drugs during the subarachnoid block (SAB). The most commonly utilized adjuvants which are used to improve the quality and duration of neuraxial anesthesia include intrathecal opioids (morphine, nalbuphine , fentanyl and sufentanil), alpha 2 adrenergic agonists (clonidine and dexmedetomidine). The technique of intrathecal administration of opioids along with local anesthetics has been extensively studied and found to provide superior quality of analgesia in a number of surgical procedures. The rationale for the combination of opioids and local anesthetics is that these drugs eliminate pain by acting at two different sites. Local anesthetics act at the nerve axon and the opioid at the receptor site in the spinal cord. Morphine is the basic reference opioid to which all analgesics of its kind are compared. It is a phenanthrene derivative, the prototypical agonist opiate at mu and kappa opioid receptors. Its poor lipid solubility favours its behaviour when injected into the intrathecal space-producing slow analgesic onset with long duration and rostral migration that facilitates some of its side effects such as pruritus, emesis, hypothermia, and respiratory depression. Nalbuphine is highly lipid soluble synthetic opioid analgesic with agonist-antagonist activity. It acts as antagonist at µ-receptors and agonist at κ-receptors. Its affinity to k-opioid receptors results in analgesia, sedation, and cardiovascular stability with minimal respiratory depression. Nalbuphine is widely studied as an adjuvant to local anesthetics in central neuraxial techniques to improve the quality of perioperative analgesia as it provides reasonably potent analgesia for visceral nociception.The present study is aimed to comparatively evaluate the clinical efficacy of morphine with nalbuphine when co-administered intrathecally with 0.5% hyperbaric bupivacaine for lower abdominal procedures. |