| CTRI Number |
CTRI/2024/03/063579 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of two different drugs on hemodynamic stability in elective lower segment cesarean section |
|
Scientific Title of Study
|
Comparative study between intrathecal 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric bupivacaine with nalbuphine as adjuvant in elective lower segment cesarean section: A randomized clinical study
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiteshwar Walia |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9878339933 |
| Fax |
|
| Email |
chiteshwarwalia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
kumarianitadr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anmol Singh |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9915302013 |
| Fax |
|
| Email |
singhanmolvirk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and research |
| Address |
Mehta Road, Vallah, Amritsar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
Department of Anaesthesia, Mehta Road, Vallah
Amritsar
PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
Levobupivacaine & Bupivacain |
2 ml hyperbaric Inj. 0.5% levobupivacaine and 2 ml hyperbaric Inj. 0.5% bupivacaine with 400mcg nalbuphine intrathecally |
| Intervention |
Nalbuphine |
400mcg nalbuphine intrathecally as an adjuvant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing elective LSCS |
|
| ExclusionCriteria |
| Details |
1. Patients with cardiovascular diseases.
2. Contraindications to regional anesthesia such as local infections/sepsis at the site of lumbar puncture, anatomical disorders of spine, shock, any bleeding disorder and patient on anticoagulants.
3. Hypersensitivity to study drugs
4. History of opioid dependence
5. Fetal distress
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of bupivacaine and levobupivacaine with combination of nalbuphine in terms of onset, regression and duration of sensory and motor blockade, time to requirement of first rescue analgesia for LSCS. |
till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the hemodyanamic effects of bupivacaine and levobupivacaine
with nalbuphine as adjuvant in elective lower segment cesarean section.
2. To evaluate the of duration of postoperative analgesia bupivacaine and
levobupivacaine with nalbuphine as adjuvant in elective lower segment
cesarean section
|
from the initiation of anaesthesia till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/03/2024 |
| 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="6"
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
|
Rationale: To compare the effectiveness of intrathecal 0.5% hyperbaric
levobupivacaine and 0.5% hyperbaric bupivacaine with nalbuphine as an adjuvant in
providing postoperative pain relief and patient satisfaction following elective lower
segment cesarean section. The research intends to guide anesthesia choices, potentially
enhancing the cesarean section recovery experience. |