| CTRI Number |
CTRI/2022/08/044592 [Registered on: 03/08/2022] Trial Registered Prospectively |
| Last Modified On: |
02/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare post op pain relief in fracture femur surgeries with 3 in 1 block using levobupivacaine alone and tramadol and butorphanol as adjuvants |
|
Scientific Title of Study
|
Comparative Study Of Tramadol And Butorphanol As Adjuvants To Levobupivacaine In 3 In 1 Block For Post Operative Analgesia In Fracture Femur Surgeries |
| Trial Acronym |
|
|
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 |
| Address |
Department of Anaesthesia
SGRDIMSAR
Amritsar PUNJAB 143001 India |
| Phone |
9878339933 |
| Fax |
|
| Email |
chiteshwarwalia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor and Head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia
Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar PUNJAB 143001 India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Junior Resident |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia
SGRDIMSAR
Amritsar PUNJAB 143001 India |
| Phone |
8837831283 |
| Fax |
|
| Email |
drzeus44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Dar Institute of Medical Sciences 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 Dar Institute of Medical Sciences & Research, Amritsar |
Department of Anaesthesia,
Sri Guru Ram Dar Institute of Medical Sciences & Research, Amritsar Amritsar PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD ethical committe |
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 |
Comparision of adjuvants given to 0.25% levobupivacaine |
comparison of duration of post operative analgesia, ease of positioning for spinal anaesthesia, post operative requirement of diclofenac 75 mg intra-venous and paracetamol 15 mg/kg intravenous will be noted. Complications occuring in each case will be noted and compared. |
| Intervention |
Group I: 0.25% Levobupivacaine 20ml and Normal Saline(2mL)as adjuvant in femoral nerve block |
Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted. |
| Intervention |
Group II: 0.25% Levobupivacaine 20 ml & tramadol 1mg/kg as adjuvant in femoral nerve block |
Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted. |
| Intervention |
Group III: 0.25% levobupivacaine 20 mL and butorphanol 0. 06mg/kg as adjuvant in femoral nerve block |
Pre spinal anaesthesia, Femoral Nerve Block with above stated drug will be given. duration of post operative analgesia and ease of positioning for spinal anaesthesia will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I-II undergoing femur fracture surgeries. |
|
| ExclusionCriteria |
| Details |
1.A known history of allergy, sensitivity or any kind of reaction to the drugs
used in the study.
2.Contraindication to neuraxial blockade (less platelet count, significant neurological disease, diagnosed increased intracranial pressure, epidural lipomatosis, tumors fracture spine, caudaequina syndrome)
3.Bleeding disorders.
4.Large inguinal lymph nodes or tumor
5.Psychiatric patients/ Unco-operative patients.
|
|
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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 compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using
• 0. 25% levobupivacaine and normal saline
• 0. 25% levobupivacaineand tramadol
• 0. 25% levobupivacaine and butorphanol
|
From the start of the Femoral nerve block to the 24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post operative analgesia using preemptive ultrasound guided three in one block using in terms of ease of positioning, duration of postop analgesia, requirement of rescue analgesia and adverse effects. |
From the start of the Femoral nerve block to the 24 hrs after surgery |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
08/08/2022 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative
pain is often undertreated. Safe and effective pain management should be the
primary goal to improve patient rehabilitation and satisfaction. Post operative
pain relief can be achieved by a variety of techniques including parental
NSAIDS (non-steroidal anti-inflammatory drugs), opioids, epidural analgesia,
patient controlled analgesia and peripheral nerve blocks. Three in one femoral
nerve block is relatively simple to perform, effective, low risk technique with
a high success rate. The 90 patients ASA grade I-II in age group 18-80
years undergoing fracture femur surgery at SGRD Amritsar will be studied with
the aim of evaluating the effectiveness of addition of tramadol or butorphanol
as adjuvants to levobupivacaine vs levobupivacaine and saline through 3 in 1
femoral nerve block randomly divided into 3 groups with 30 patients each
receiving preemptive three in one nerve block either using 0.25%
Levobupivacaine alone (Group I) or tramadol 1mg/kg (Group II) or butorphanol 0.
06mg/kg as adjuvant to 0.25% levobupivacaine (Group III). To every patient
spinal anaesthesia using 0.5% heavy bupivacaine will be given. Ease of
positioning, pain relief, and duration of post operative analgesia in all the
three groups will be compared. In addition, post operative requirement of
intravenous diclofenac 75 mg will be evaluated. |