| CTRI Number |
CTRI/2024/12/078110 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of 2 drugs(nalbuphine and magnesium sulphate) with levobupivacaine in infra umbilical surgeries |
|
Scientific Title of Study
|
Comparative Study Between Nalbuphine V/S Magnesium Sulphate As An Adjuvant To Intrathecal Hyperbaric Levobupivacaine In Infraumbilical Abdominal
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 |
Dr Samundra Saini |
| Designation |
Junior Resident |
| Affiliation |
Hind Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, U.P, 261303
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
8077102951 |
| Fax |
|
| Email |
samundra.saini1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSudhir Kumar Rai |
| Designation |
Professor |
| Affiliation |
Hind Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, U.P, 261303
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
9455106967 |
| Fax |
|
| Email |
sudhir.rai17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSudhir Kumar Rai |
| Designation |
Professor |
| Affiliation |
Hind Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, U.P, 261303
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
9455106967 |
| Fax |
|
| Email |
sudhir.rai17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur,U.P, 261303 |
|
|
Primary Sponsor
|
| Name |
Hind Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur,U.P, 261303 |
| Type of Sponsor |
Other [None] |
|
|
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 Samundra Saini |
Hind Institute of Medical Sciences |
Room Number 57, OT Complex, Department of Anaesthesia and Critical Care, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, U.P, 261303
Sitapur
UTTAR PRADESH |
8077102951
samundra.saini1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine with Magnesium Sulphate or Nalbuphine |
Comparison of block characteristics in terms of Time Taken for Onset of Sensory and Motor Block.
Duration of Motor Block.
Time for First Rescue Analgesia.
Intraoperative Vitals- PR, MAP, BP, SpO2, Adverse Effects if Any.
Post-operative VAS Monitoring, Vitals and Adverse Effects if Any. |
| Comparator Agent |
Levobupivacaine with Magnesium Sulphate or Nalbuphine |
Time Taken for Onset of Sensory and Motor Block. Duration of Motor Block. Time for First Rescue Analgesia. Intraoperative Vitals- PR, MAP, BP, SpO2, Adverse Effects if Any. Post-operative VAS Monitoring, Vitals and Adverse Effects if Any. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-1 and ASA-2
Age 18yrs to 60 yrs |
|
| ExclusionCriteria |
| Details |
Patient Refusal
Pregnancy
Obesity
Contra Indication to Spinal Anaesthesia
Allergy to Study Drug
Patients with Cardiac, Liver and Renal Disease
Previous Surgery of Lumbar Spine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of block characteristics in terms of Time taken for onset of sensory and motor blocks. Duration of sensory and motor blocks |
Assess the heart rate, blood pressure, oxygen saturation and MAP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesic effect, Peak VAS pain scores during recovery period, Total amount of rescue analgesia used. Post-operative hemodynamic changes. |
Assess the VAS Score , Vitals in Post-operative period every 30 mins till 2 hours and every 1 hour till 12 hours, time taken for first rescue Analgesia. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/12/2024 |
| 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="0"
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
|
TITLE- COMPARATIVE STUDY BETWEEN NALBUPHINE V/S MAGNESIUM SULPHATE AS AN ADJUVANT TO INTRATHECAL HYPERBARIC LEVOBUPIVACAINE IN INFRAUMBILICAL ABDOMINAL SURGERIES
Introduction - Regional anaesthesia (RA) significantly reduces pre- and postoperative side effects and is preferred over general anaesthesia due to fewer complications, early onset, and specific action. Spinal anaesthesia, widely used for infraumbilical surgeries, offers reversible sensory, motor, and sympathetic blockade with minimal systemic effects, utilizing hyperbaric, isobaric, or hypobaric solutions. Levobupivacaine, a safer S(-) enantiomer of bupivacaine, has lower cardiotoxicity and neurotoxicity, acting through sodium channel blockade. Nalbuphine, a semisynthetic opioid with μ antagonist and Κ agonist effects, enhances analgesia with minimal side effects when used intrathecally. Magnesium, via NMDA receptor antagonism, supports pain modulation but has limited CSF penetration.
Hypothesis - Null Hypothesis: Adjuvant use of Nalbuphine is equal in every aspect to MgSO4 for comparison when given with levobupivacaine.
Alternate Hypothesis: Adjuvant use of Nalbuphine provides better block characteristics as compared to MgSO4.
|