| CTRI Number |
CTRI/2024/06/069194 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the analgesic efficiency among paracetamol, ibuprofen and paracetamol-ibuprofen given preoperatively by monitoring vitals intraoperatively and VAS score postoperatively in orthopedic surgeries. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of pre-emptive paracetamol, ibuprofen and paracetamol-ibuprofen in orthopedic 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 |
Abhinav Rawat |
| Designation |
Post graduate student |
| Affiliation |
Govt Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9888980472 |
| Fax |
|
| Email |
rawatabhinav1769@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Block D, Level 5,Government Medical College
and Hospital, sector 32-B, Chandigarh, India, Pincode- 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5,
GMCH, Sector 32B, Chandigarh, India, Pincode- 160030 |
| 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 |
| Abhinav Rawat |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh Chandigarh CHANDIGARH |
09888980472
rawatabhinav1769@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ibuprofen |
Injection 400 mg intravenously given preoperatively 15 mins before induction |
| Intervention |
Paracetamol |
Injection 1 gm intravenous given preoperatively 15 mins before induction. |
| Comparator Agent |
Paracetamol and Ibuprofen |
Injection paracetamol 1 gm and injection 400 mg intravenously given preoperatively 15 mins before induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1 ASA class I or II
2 Age from 18 to 70 years either sex
3 Measuring 150 to 180 cm height, with body mass index BMI of 18 to 35 kg per m2
4 Patients undergoing elective and emergency orthopaedic surgeries requiring spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1 All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre existing neurological deficits in lower extremities, unwillingness to give consent.
2 Surgical duration more than 2 hours
3 Sensory blockade inadequate for surgery.
4 Patients having cardiac rhythm abnormalities.
5 History of alcoholism, drug abuse, and psychiatric disorders.
6 History of allergy to any of the study drugs.
7 Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders.
8 Chronic pain patients undergoing treatment with opioid analgesic.
9 Pregnant patients.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
Pain will be assessed with Visual Analogue Scale between 0 and 10
|
1 Pain will be assessed with Visual Analogue Scale between o and 10 at every 15 minutes till 2 hours and then after every 2 hours till 6 hours and then after 12th hour and at 24th hour in ward.
2 Time of onset of T10 sensory block and time to peak sensory block will be noted
3 Time of onset of Bromage 3 motor block will be noted.
4 Time of supplemental analgesia administered
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1 To assess the haemodynamics intraoperatively & postoperatively.
2 To assess the adverse effects.
|
1 Haemodynamics like heart rate mean arterial pressure oxygen saturation spo2 will be recorded every 5 minutes during the intraoperative period. Thereafter the parameters will be observed after every 15 minutes till 2 hours postoperatively & thereafter every 2 hours till 6 hours & then at 12th hour & 24th hour postoperatively in ward.
 
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|
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Target Sample Size
|
Total Sample Size="109" Sample Size from India="109"
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)
|
30/06/2024 |
| 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
|
The
109 patients will be randomly divided into three groups:
1. Group
B (n=36) will receive 400 mg of Ibuprofen intra-venously 15 minutes before
induction
2. Group
D (n=36) will receive 1 gm of Paracetamol intra-venously 15 minutes before
induction.
3. Group
P (n=36) will receive 400 mg of Ibuprofen intra-venously and 1 gm of
Paracetamol intra-venously 15 minutes before induction.
Procedure on the day of surgery: 15 minutes before induction , the patients in group B will receive 400 mg of inj ibuprofen intravenously, the patients in group D will receive 1 gm of inj paracetamol intravenously, the patients in group P will receive 400 mg of inj ibuprofen and 1 gm of inj paracetamol intravenously. The
operating room will be prepared and anaesthesia machine will be checked. All
emergency drugs and equipment will be placed and checked in the operation
theatre preoperatively. Standard monitoring with the continuous
electrocardiogram , heart rate , non-invasive blood pressure ,
oxygen saturation will be done and will be
started before induction of anaesthesia. An 18 gauge intravenous cannula will
be inserted in large vein of dorsum of non-dominant hand and intravenous line
and normal saline at 10 ml/kg will be started for preloading. The study drugs
will be administered as a single dose, i.e. 15 minutes before spinal
anaesthesia. Under strict asepsis, lumbar puncture will be performed at L3-L 4
or L4-L5 spinal interspace, in sitting position, through a standard midline
approach using a 26-G Quincke spinal needle. Hyperbaric, bupivacaine 0.5% 15
mg will be injected intrathecally.
The haemodynamics
like heart rate , mean arterial
pressure , oxygen saturation , will be recorded every 5 minutes
during the intraoperative period. Thereafter, the parameters will be observed
after every 15 minutes till 2 hours postoperatively and thereafter every 2
hours till 6 hours and then at 12th hour and 24th hour
postoperatively in ward.
Pain will be
assessed using Visual Analogue Scale. It is linear scale, consisting of 10 cm
line anchored at one end by a label such as No pain and other end by Worst
pain imaginable. Patient simply marks the line to indicate the pain intensity.
Pain intensity will be checked when patient is planned to be shifted to
postoperative area. It will be baseline pain intensity and patients will be
followed up every 15 minutes for next 2 hours in post operative area. Then
after every 2 hours till 6 hours and then at 12th hour and finally
at 24th hour in wards. Patients with a VAS score of 3 or more will
receive injection Diclofenac sodium 75-mg intramuscularly as rescue analgesia
whenever it happens. The study will be over when rescue analgesic is administered
or after postoperative 24 hours in the ward. The
time from administration of spinal anaesthesia to time of rescue analgesia will
be total analgesia duration. The
surgery will be conducted as per procedure and no analgesic will be
administered intra-operatively. The patient will be shifted to postoperative
room and will be monitored there for next 2 hours and then at 6th
hour, 12th hour and 24th hour in the ward for post
operative pain.
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