| CTRI Number |
CTRI/2024/03/064491 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two nerve blocks, pericapsular nerve group block with lateral femoral cutaneous nerve block as an adjunct to spinal anaesthesia and comparing it with effect of Combined spinal epidural anaesthesia in patients undergoing total hip replacement. |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION BETWEEN A COMBINATION OF PERICAPSULAR NERVE GROUP (PENG) BLOCK AND LATERAL FEMORAL CUTANEOUS NERVE (LFCN) BLOCK AS AN ADJUNCT TO SPINAL ANAESTHESIA VERSUS COMBINED SPINAL EPIDURAL ANAESTHESIA FOR POSTOPERATIVE ANALGESIA AND FUNCTIONAL RECOVERY FOLLOWING TOTAL HIP ARTHROPLASTY: 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 |
Sudarshan Kumar Garg |
| Designation |
Junior Resident |
| Affiliation |
Army Hospital Research and Referrall, New Delhi |
| Address |
Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt
New Delhi DELHI 110010 India |
| Phone |
9915421282 |
| Fax |
|
| Email |
sudarshan.garg@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajeev Nair |
| Designation |
Professor |
| Affiliation |
Army Hospital Research and Referral, New Delhi |
| Address |
Head of Department, Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt
New Delhi DELHI 110010 India |
| Phone |
7757024594 |
| Fax |
|
| Email |
rjv.nr1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sudarshan Kumar Garg |
| Designation |
Junior Resident |
| Affiliation |
Army Hospital Research and Referral, New Delhi |
| Address |
Department of Anaesthesiology, Army Hospital Research and Referral, New Delhi, Delhi Cantt
New Delhi DELHI 110010 India |
| Phone |
9915421282 |
| Fax |
|
| Email |
sudarshan.garg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral, Delhi Cantt |
|
|
Primary Sponsor
|
| Name |
Dr Rajeev Nair |
| Address |
Army Hospital Research and Referral, New Delhi 110010 |
| Type of Sponsor |
Other [self] |
|
|
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 Sudarshan Garg |
Army Hospital Research and Referral |
Department of Anaesthesiology New Delhi DELHI |
9915421282
sudarshan.garg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Army Hospital R&R, Delhi Cantt |
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 |
Combined Spinal Epidural Anaesthesia |
Patient will receive two injections in the spine which will be given after locally anaesthetising the area. A catheter will be placed through one of the injection which will be connected to a continuous drug infusion pump to control postoperative pain. Injection will be given reparative just before surgery and monitoring will be done for 48 hours. |
| Intervention |
Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve along with Spinal Anaesthesia |
Patient will receive Spinal Anaesthesia in which an injection will be given in the spine of the patient and lower part of the body will be anaesthetised. After achieving complete anaesthesia of the lower limbs, two injections will be given in the thigh through which drugs will be given to control the postoperative pain.
Injections will be given preoperatively just before surgery and monitoring will be done for 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Physical status I- III
2. Patient consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to participate in the study.
2. Patients having coagulopathy.
3. Patients allergic to local anesthetic (LA)
4. Patients having sepsis.
5. Patients with hepatic or renal failure,
6. Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative Pain Scores
Postoperative Motor strength |
0,6,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Use of Rescue Analgesia
Time to 1st walk |
12, 24 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="8" 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
|
Eligible patients will be randomly allocated into two groups to receive either Pericapsular Nerve Group (PENG) block with Lateral Femoral Cutaneous Nerve (LFCN) block as an adjunct to Spinal Anaesthesia (Group - A) or Combined Spinal Epidural Anaesthesia (Group B). Randomization will be achieved using computer-generated lists and treatment allocation concealed using consecutively numbered, sealed, opaque envelopes. Every patient will be informed of the sequence of procedures during anaesthesia and surgery, and signed informed consent in their vernacular language will be obtained before enrolment. Group A will receive Spinal Anaesthesia under all aseptic precautions using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space. Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be administered in the subarchnoid space. After receiving spinal anaesthesia patients will be givenultrasound guided Pericapsular Nerve Group (PENG) block and Lateral Femoral Cutaneous nerve block preoperatively using stimuplex needleand Inj Bupivacaine 0.25% plain 20ml will be given for PENG block and 5ml for Lateral Cuteness Femoral Nerve Block. Group B will receive Combined Spinal Epidural Anaesthesia under all aseptic conditions. Spinal Anaesthesia using Quincke spinal needle 25G/26G in L2-L3 / L3-L4 space and Inj Bupivacaine H 0.5% 2.5ml with Inj Fentanyl 25mcg 0.5ml will be given. Epidural Anaesthesia will be given using 18G Touhy’s needle and catheter will be left in situ. Postoperative controlled drug administration of InjBupivacaine 0.125% through epidural catheter will be done and infusion will be started at 5ml/hr initially which will be titrated in the next 1-2 days according to the pain. In both the groups, rescue analgesia of Inj Tramadol 100mg iv will be administered as requirement basis. At all postoperative time points (0, 6, 12, 24 hr) patients will be asked to indicate perceived pain using a 0-10 VAS score (0- No pain, 10- Worst pain). Motor recovery of the hip joint will be assessed at 24 h using range of motion, where active hip flexion (between 0° and 90°) will be measured using a goniometer. In addition, ‘time to first walk’, defined as the time between the end of surgery and the ability to take at least three steps with the help of the walker, will be recorded after the first 12 postoperative hours, and re-evaluated on the first postoperative day. Outcome assessment will be performed by a different clinician who will be blinded to the group allocation. |