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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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