| CTRI Number |
CTRI/2025/02/080720 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing PENG Block and Anterior QL Block for Comfort and Pain Relief After surgeries around Hip.
|
|
Scientific Title of Study
|
To study and compare pericapsular nerve block versus anterior qudratus lumborum block for ease of position during spinal and post operative analgesia in patients undergoing orthopaedic hip surgeries under spinal anaesthesia-a prospective randomized controlled study |
| 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 Manisha Kumari |
| Designation |
Junior resident |
| Affiliation |
Dr. RPGMC TANDA |
| Address |
Department of Anaesthesia, Dr. RPGMC TANDA at Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816601763 |
| Fax |
|
| Email |
manishak524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhanu gupta |
| Designation |
Assistant professor |
| Affiliation |
Dr. RPGMC TANDA kangra |
| Address |
Department of Anaesthesia,Dr RPGMC TANDA kangra
ROOM NUMBER 101 Operation theatre complex 3rd floor department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh
176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhanu gupta |
| Designation |
Assistant professor |
| Affiliation |
Dr. RPGMC TANDA kangra |
| Address |
Department of Anaesthesia,Dr RPGMC TANDA kangra
ROOM NUMBER 101 Operation theatre complex 3rd floor department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh
176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418016807 |
| Fax |
|
| Email |
bhanurpgmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Superintendent Office Room No. 203 First Floor(Block A)Dr Rajendra Prasad Government Medical College Tanda Kangra Himachal PRADESH |
|
|
Primary Sponsor
|
| Name |
DR Manisha kumari |
| Address |
Department of Anaesthesiology Dr RPGMC Kangra at Tanda District Kangra State Himachal Pradesh,India,Pin code 176001 |
| 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 Manisha |
DR RPGMC Kangra Hospital at Tanda Himachal Pradesh |
Operation Theatre Complex 3rd floor Department of Anaesthesiology Dr RPGMC Kangra at Tanda Himachal Pradesh 176001
Kangra
HIMACHAL PRADESH |
9816601763
manishak524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Dr RPGMC Kangra at Tanda |
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 |
Ultrasound guided Anterior Quadratus Lumborum block |
Patient undergoing orthopedic surgeries around hip will receive ultrasound guided Anterior Quadratus lumborum block with 20 ml of 0.25% Bupivacaine .Patients followed up for duration of analgesia post operatively for 48 hrs and compared with duration of analgesia provided by PENG block |
| Intervention |
Ultrasound guided Pericapsular Nerve Group block |
Patient undergoing orthopedic surgeries around hip will receive ultrasound guided Pericapsular Nerve Group block with 20 ml of 0.25% Bupivacaine .Patients followed up for duration of analgesia post operatively for 48 hrs and compared with duration of analgesia provided by Anterior Quadratus Lumborum block. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II ,III
BMI -18.5- 24.9kg/m2
Orthopaedic surgery around hip |
|
| ExclusionCriteria |
| Details |
Fracture old than 2 weeks
Unwilling patients
Pregnancy
Patient having no pain while sitting
Any bleeding disorder and patient on anticoagulant.
Neurological and musculoskeletal disease.
Local infection at the site of injection.
History of allergy to local anaesthetic agent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To analyse & compare pain using visual analogue scale (VAS) at rest and 15 degrees passive leg elevation at 0, 10 minutes and 20, 30 minutes after giving US guided PENG block & QL Block.
2) To evaluate & compare ease of giving a sitting position for spinal anaesthesia using 4-point EOSP score in both the groups.
3) To evaluate & compare time to first rescue analgesia in both groups.
4) To evaluate & compare total pain free period in both the groups.
5) To evaluate & compare the consumption of total doses of inj diclofenac as post operative analgesic requirement in both the group.
6) Patient satisfaction score.
|
0min 10min 20min 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor and compare hemodynamic parameter at rest and 15 degree passive leg elevation |
0min 10 min 20 min 30 min |
|
|
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)
|
27/02/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included manishak524@gmail.com).
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Peripheral nerve group block provide good pain relief after surgery .Pericapsular nerve group block mainly target smaller branches of femoral nerve and nerve around the hip joint those sense pain around hip .This makes pericapsular nerve group block great for pain relief in surgeries aound hip. Anterior quadratus lumborum block is also effective in providing pain relief during positioning for spinal anesthesia as well as also provide pain relief post surgery.so we will study and compare their role in ease of positioning for giving spinal anesthesia and quality of analgesia as well as duration of post operative analgesia . |