CTRI Number |
CTRI/2021/03/031729 [Registered on: 05/03/2021] Trial Registered Prospectively |
Last Modified On: |
24/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two drugs in spinal anesthesia for pain relief in post operative period |
Scientific Title of Study
|
Comparison of Post Operative Analgesia between Intrathecal Nalbuphine VS Fentanyl in Spinal Anaesthesia - A Double blinded Randomised Controlled Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jananimadi |
Designation |
Pg resident |
Affiliation |
Pondicherry institute of medical sciences |
Address |
Dept of anesthesia, Pondicherry institute of medical sciences, kalapet
Pondicherry PONDICHERRY 605014 India |
Phone |
9751110232 |
Fax |
|
Email |
jananimadi92.jm@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr hariharasudhan |
Designation |
Assistant professor |
Affiliation |
Pondicherry institute of medical sciences |
Address |
Department of anesthesia, Pondicherry institute of medical sciences, kalapet
Pondicherry PONDICHERRY 605014 India |
Phone |
8861085422 |
Fax |
|
Email |
hsknight071@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr hariharasudhan |
Designation |
Assistant professor |
Affiliation |
Pondicherry institute of medical sciences |
Address |
Department of anesthesia, Pondicherry institute of medical sciences, kalapet
Pondicherry PONDICHERRY 605014 India |
Phone |
8861085422 |
Fax |
|
Email |
hsknight071@gmail.com |
|
Source of Monetary or Material Support
|
Pondicherry institute of medical sciences |
|
Primary Sponsor
|
Name |
Pims |
Address |
Pondicherry institute of medical sciences, kalapet |
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 jananimadi |
Pondicherry institute of medical sciences |
Anesthesia department Pondicherry PONDICHERRY |
9751110232
jananimadi92.jm@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Fentanyl |
0.5% bupivacaine 2.5ml and 25mcg fentanyl intrathecally |
Comparator Agent |
Nalbuphine |
0.5% bupivacaine 2.5ml and Nalbuphine 1mg intrathecally |
Intervention |
Postoperative pain |
Injection diclofenac 75mg iv stat |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1Patients belonging to ASA I & II
2Aged between 18 & 65 years
3 Patient undergoing elective infra umbilical surgeries |
|
ExclusionCriteria |
Details |
1Patients with raised intracranial pressure or any intracranial pathology
2 Hypovolemia, Bradycardia
3 Patients on anticoagulants
4 Localised infection
5 Pregnant women
6 Allergy to local anaesthetics. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
to compare the duration of analgesia of nalbuphine and fentanyl in postoperative period in addition to bupivacaine in spinal anesthesia by using VAS score |
24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) to compare the onset and duration of sensory and motor blockade
2)to compare the hemodynamic parameters |
24hours |
|
Target Sample Size
|
Total Sample Size="166" Sample Size from India="166"
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
11/03/2021 |
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="5" Days="30" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Adding adjuvant drugs to intrathecal local anaesthetics improves quality and duration of sensory blockade and prolongs postoperative analgesia. Intrathecal opioids are synergistic with local anaesthetics, thereby intensifying the sensory block without increasing sympathetic block. (1) In 2016, wahi et al conducted with 30 patients in each group using bupivacaine with clonidine and studied the duration of sensory and motor block and concluded that addition of clonidine to bupivacaine intrathecally is a reliable method to prolong spinal anaesthesia but close monitoring for hypotension was to be noted.(4) In 2012, safari et al did a study on 90 opium abuser patients were selected and randomly assigned into 3 groups. The patients received bupivacaine-midazolam and bupivacaine-fentanyl group; both were longer than the plain bupivacaine group. Therefore midazolam is more effective than fentanyl in such cases.(5) Minagar et al conducted a study with one hundred patients between fifty patients were randomly allocated to receive dexmedetomidine and Bupivacaine and vital sign parameters were studied and concluded that intrathecal dexmedetomidine increases the duration of analgesia and reduces postoperative pain without changes in the hemodynamic parameters and adverse side effects. It can be considered as an appropriate adjuvant to intrathecal local anaesthetics for lower limb surgeries.(6) Fernandez et al did a study with forty patients undergoing knee or hip replacement were studied. They received fentanyl with Bupivacaine and Bupivacaine and the results showed that 25 micrograms of spinal fentanyl do not modify spinal anaesthesia in the elderly, but induces pruritus and O2 desaturation. The decrease in postoperative pain intensity and the preservation of cognitive function would justify the use of spinal fentanyl in the elderly.(7) A prospective, randomized, double-blind, and comparative study was conducted on 150 parturients in 2018 by bindra et al and were randomized into three groups with fifty patients in each group. They received bupivacaine with nalbuphine and bupivacaine with fentanyl and concluded intrathecal nalbuphine prolongs postoperative analgesia maximally and may be used as an alternative to intrathecal fentanyl in cesarean section(8) There are very few large studies that have compared intrathecal nalbuphine with intrathecal fentanyl added to hyperbaric bupivacaine infra umbilical surgeries. Therefore, we designed a randomized double-blind study to compare the effects of intrathecal nalbuphine and fentanyl as adjuvants to bupivacaine patients undergoing infra umbilical surgeries. The aim of this study was to compare fentanyl with nalbuphine as intrathecal adjuvant to 0.5% hyperbaric bupivacaine in terms of sensory and motor blockade characteristics and duration of postoperative analgesia and hemodynamic changes. |