| CTRI Number |
CTRI/2025/07/092100 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing efficacy of two analgesics in controlling shivering after spinal anaesthesia
|
|
Scientific Title of Study
|
Efficacy of preoperative paracetamol IV infusion versus diclofenac IV infusion in preventing shivering in patients undergoing lower abdominal surgery under spinal anaesthesia: A randomised controlled trial |
| 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 Pavitra L |
| Designation |
Post graduate in Anaesthesiology |
| Affiliation |
Ballari Institute of medical sciences and research Center |
| Address |
Dept.of Anaesthesiology
Cantonment
Ballari
Dept.of Anaesthesiology
Cantonment
Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9164336430 |
| Fax |
|
| Email |
Pavitra.lm42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bala Subramanya H |
| Designation |
Professor |
| Affiliation |
Ballari Institute of medical sciences and research Center |
| Address |
Dept of Anaesthesiology
Ballari Medical College and Research Centre
Ballari
Dept of Anaesthesiology
Ballari Medical College and Research Centre
Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavitra L |
| Designation |
Post graduate in Anaesthesiology |
| Affiliation |
Ballari Institute of medical sciences and research Center |
| Address |
Dept.of Anaesthesiology
Ballari Medical College and Reasearch Centre
Ballari 583104
Dept.of Anaesthesiology
Ballari Medical College and Reasearch Centre
Ballari 583104
Bellary
KARNATAKA
583219
India |
| Phone |
9164336430 |
| Fax |
|
| Email |
Pavitra.lm42@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ballari Medical College and Research Center, Ballari, Karnataka state, India 583104
|
|
|
Primary Sponsor
|
| Name |
Ballari Medical College and Research Center, ballari |
| Address |
Cantonment
Ballari
Karnataka
Pin 583104 |
| Type of Sponsor |
Government 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 Pavitra L |
Ballari Medical College and Research Centre |
Department of Anaesthesiology
BMCRC
Ballari
Bellary
KARNATAKA |
9164336430
Pavitra.lm42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,BMCRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Post operative paracetamol iv infusion versus diclofenc ib infusion in preventing shivering in patients undergoing lower abdominal surgeries under spinal anaesthesia |
Paracetamol 1gm iv infusion in group P compared with pre operative diclofenc 75mg in group D in 120 each patients both administered over 10 minutes before administering spinal anaesthesia with primary objective of comparing incidence of post spinal shivering. |
| Comparator Agent |
Pre operative Paracetamol IV infusion versus diclofenac IV infusion in preventing shivering in patients undergoing lower abdominal surgeries under spinal anaesthesia |
Paracetamol 1 gm IV infusion in Group P compared with Pre operative Diclofenac 75 mg in Group D in 120 each patients both administered over 10 minutes before administering spinal anaesthesia with primary objective of comparing incidence of post spinal shivering |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing lower abdominal surgery under spinal anaesthesia
Patients belonging to ASA grade I - II
Patients with BMI 25 - 30
|
|
| ExclusionCriteria |
| Details |
Patient refusal for study
Any contra indication for spinal anaesthesia
Allergy to study drugs
Patients with severe systemic disorder
Major Surgery where fluid shifts are expected
Surgery prolonging more than 2 hours of duration |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of post spinal shivering in two groups |
5 mins,10 mins,15 mins,20 mins,30 mins,1 hour,2 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
In the intra operative and first 24 hours post operative period |
1)Time of Onset of shivering, 2)total number of intra operative and post operative episodes of shivering and duration of each episode
3)Severity of post spinal shivering
4.Time of first rescue anti shivering medication and number of rescue doses given
5.Body temperature
6,Total requirement of rescue dose of analgesics in first 24 hours
7.Haemodynamic parameters
8.Number of episodes of PONV |
In the intra operative and immediate post operative period |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 4 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2025 |
| 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 Applicable |
| 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 Efficacy of Paracetamol IV Infusion versus Diclofenac IV Infusion in Preventing Shivering in Patients Undergoing Lower Abdominal Surgery under Spinal Anesthesia
Objective To compare the efficacy of intravenous (IV) paracetamol and IV diclofenac in preventing shivering in patients undergoing lower abdominal surgery under spinal anesthesia.
Methodology This study will likely involve a randomized controlled trial design, where patients are allocated to receive either IV paracetamol or IV diclofenac. The incidence and severity of shivering will be assessed and compared between the two groups.
Expected Outcome The study aims to determine whether IV paracetamol or IV diclofenac is more effective in preventing shivering in patients undergoing lower abdominal surgery under spinal anesthesia, providing valuable insights for clinical practice.
Significance Shivering is a common complication of spinal anesthesia, and effective prevention can improve patient comfort and outcomes. This study will contribute to the existing literature on the use of IV paracetamol and diclofenac for shivering prevention. |