CTRI Number |
CTRI/2023/12/060752 [Registered on: 26/12/2023] Trial Registered Prospectively |
Last Modified On: |
22/12/2023 |
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
|
In patients undergoing gynaecological surgeries, a comparison will be done between levobupivacaine with nalbuphine and fentanyl for post-operative analgesia administered during spinal anesthesia. |
Scientific Title of Study
|
Comparision of Post Operative Analgesia Between Nalbuphine and Fentanyl as adjuvant with intrathecal Levobupivacaine for lower abdominal Gynaecological Surgeries |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saely Shekhar Paunikar |
Designation |
Junior Resident, |
Affiliation |
Datta Meghe Institute of Higher Education and Research |
Address |
Department of anaesthesia Jawaharlal Nehru Medical College Sawangi(Meghe) Wardha MAHARASHTRA 442001 India |
Phone |
9892132765 |
Fax |
|
Email |
saely21@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sanjot Ninave |
Designation |
Professor |
Affiliation |
Datta Meghe Institute of Higher Education and Research |
Address |
Department of anaesthesia Jawaharlal Nehru Medical College Sawangi(Meghe) Wardha MAHARASHTRA 442001 India |
Phone |
|
Fax |
|
Email |
drsusann02@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Saely Shekhar Paunikar |
Designation |
Junior Resident, |
Affiliation |
Datta Meghe Institute of Higher Education and Research |
Address |
Department of anaesthesia Jawaharlal Nehru Medical College Sawangi(Meghe)
MAHARASHTRA 442001 India |
Phone |
9892132765 |
Fax |
|
Email |
saely21@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Jwaharlal Nehru Medical College |
Address |
Department of Anaesthesia
Datta Meghe Institute of Higher Education and Research |
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 Saely Paunikar |
Acharya Vinoba Bhave Rural Hospital |
Department of Anaethesia, AVBRH, Jawaharlal Nehru Medical College Wardha MAHARASHTRA |
9892132765
saely21@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Datta Meghe Institute of Higher Education and Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: N888||Other specified noninflammatory disorders of cervix uteri, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Fentanyl 12.5 mcg intrathecal |
post operative analgesia will be assessed between fentanyl and nalbuphine with levobupivacaine till 180 mins |
Intervention |
Nalbuphine 1mg intrathecal |
post operative analgesia will be assessed between fentanyl and nalbuphine with levobupivacaine till 180 mins |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
1 Age between 35-75 years
2 Lower Abdominal surgeries under Subarachnoid Block
3 Duration of Surgery 2 hours
4 ASA I & II
5 MPC I & II
6 Patients willing to participate in the study
|
|
ExclusionCriteria |
Details |
1 Lack of valid informed written consent
2 ASA grade III and IV
3 Infection at the subarachnoid block injection site
4 Patients with neurological and musculoskeletal disease
5 Patients with bleeding disorders
6 Patients on anticoagulants
7 History of allergy to local anesthetic, Fentanyl and Nalbuphine
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
We are trying to prove the hypothesis that addition of adjuvant 1 mg Inj.Nalbuphine intrathecally to Hyperbaric Levobupivacaine prolongs the duration of post-operative analgesia more as compared 25mcg Inj.Fentanyl intrathecally with hyperbaric levobupivacaine |
post operative analgesia will be assessed as the primary outcome and it will be monitored for 2 hrs post spinal anaesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
nil |
nil |
|
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
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
01/01/2024 |
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="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spinal anaesthesia
has a rapid onset and complete motor blockade and also simple to perform.
It has lower incidence of failed block and the local anaesthetic requirement is
less. Hence spinal anesthesia is a preferred anaesthetic technique for lower
abdominal surgeries. Adjuvants to local anaesthetics for intrathecal
administration has some advantages. They have synergistic action & intensify sensory block without increasing sympathetic block, reduced
local anaesthetic drug dose, better hemodynamic stability with lesser side
effects.
Fentanyl is a pure mu receptor agonist. The common mu agonist side
effects are nausea, vomiting, sedation, urinary retention and
respiratory depression. It is lipophilic in nature, with rapid onset of action following intrathecal
administration. The intrathecal drug administration does not produce
respiratory depression. It improves anaesthetic quality without much
complications. Nalbuphine is a mixed
kappa agonist and mu antagonist opioid drug, which produces analgesia without
much side effects of mu receptor agonist action.
Levobupivacaine is a
local anaesthetic amide which can produce better sensory and motor block with
good hemodynamic profile than bupivacaine. Levobupivacaine is less cardiotoxic than bupivacaine. (1) Many investigators have studied the characteristics of intrathecal
nalbuphine & fentanyl with levobupivacaine.
The purpose of this study is to compare the efficacy of fentanyl & nalbuphine as adjuvants to intrathecal levobupivacaine for post-operative
analgesia following lower abdominal gynaecological surgeries. |