| CTRI Number |
CTRI/2023/06/053501 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| 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 which group gives better pain relief in patients undergoing hip surgeries |
|
Scientific Title of Study
|
To evaluate the Postoperative analgesic effect of Perineural versus Intravenous dexamethasone in Ultrasound guided Pericapsular Nerve Group block (PENG block) in patients undergoing hip fracture surgery under spinal Anaesthesia- A Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MALAINESAN E |
| Designation |
postgraduate |
| Affiliation |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUE |
| Address |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE , KATHIRKAMAM , PUDUCHERRY.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
8531042984 |
| Fax |
|
| Email |
malainesan231097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRATHEEBA NATRAJAN |
| Designation |
PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUE, KATHIRKAMAM, PUDUCHERRY.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9894919554 |
| Fax |
|
| Email |
pratheeba.rk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATHEEBA NATRAJAN |
| Designation |
PROFESSOR DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUE |
| Address |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, KATHIRKAMAM, PUDUCHERRY.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9894919554 |
| Fax |
|
| Email |
pratheeba.rk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi medical college |
|
|
Primary Sponsor
|
| Name |
indira ghandhi medical college and research institute |
| Address |
kathirkamam , pudhucherry |
| Type of Sponsor |
Government medical college |
|
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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 |
| MALAINESAN E |
INDIRA GHANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
ORTHOPEDIC OPERATION THEATRE
DEPARTMENT OF ANESTHESIOLOGY
Pondicherry
PONDICHERRY |
8531042984
malainesan231097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular nerve group block with injectate dexamethasone. |
the PENG block will be performed with patient in supine position.A curvilinear low frequency ultrasound probe (2-5MHZ) will be initially placed in transverse plane over the anterior inferior iliac spine and then align with pubic ramus by rotating the probe counterclockwise approximately 45 degree. In this view the iliopubic eminence, iliopsoas muscle and tendon,femoral artery and pectineus muscle visualized.A 23 gauge quinke needle is inserted and the tip is placed in the musculofascial plane between the psoas tendon anteriorly and pubic ramus posteriorly. Injectate containing 20 ml of 0.25% bupivacaine with dexamethasone 8mg will be injected at the target site and spread in plane is observed.
|
| Comparator Agent |
Pericapsular nerve group block with intravenous dexamethasone. |
In PENG+IVD group ,the PENG block will be performed with patient in supine position.A curvilinear low frequency ultrasound probe (2-5MHZ) will be initially placed in transverse plane over the anterior inferior iliac spine and then align with pubic ramus by rotating the probe counterclockwise approximately 45 degree. In this view the iliopubic eminence, iliopsoas muscle and tendon,femoral artery and pectineus muscle visualized.A 23 gauge quinke needle is inserted and the tip is placed in the musculofascial plane between the psoas tendon anteriorly and pubic ramus posteriorly. Injectate containing 20 ml of 0.25% bupivacaine only will be injected ,simultaneous followed by intravenous injection of dexamethasone 8 mg.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to take part in the study.
2. Age greater than 18 years including both the sex.
3. ASA 1 and ASA 2 patients.
4. Weight more than 50 kg |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection at the site of block
3. Contraindication to regional anaesthesia such as bleeding diathesis ,patients on anticoagulants
4. Known allergy to local anaesthetic​​​​​​
5. Inability to provide the consent
6. Psychiatric patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Request for first postoperative analgesia |
Time from which the block has performed to the time when the Numeric Rating Scale score is above 6 in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease positioning for spinal anaesthesia |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The approval of the Institutional Research &Ethics Committee will be obtained and the patients will be randomly allocated (computer-generated random numbers) to 2groups Group I (PENG +PND) and Group 2 (PENG +IVD) . Written informed consent will be obtained from all patient participating in study.Inclusion criteria includes all American Society of Anesthesiologists physical status I and II , age greater than 18 years, weight greater than 50 kg, scheduled for hip fracture surgeries (Intertrochanteric fracture ,Subcapital fracture,Hip hemiarthroplasty ,Total hip arthroplasty )will be involved in the study. Postoperatively patients will be shifted to PACU ,where the Numeric rating score (NRS) will be recorded at 30 minutes at first , followed by 1st , 4th , 6th , 8th , 12th ,18th and 24 hr.If the Patient complains of pain and if the NRS >6 at any hour rescue analgesic of 1 gm of intravenous paracetamol will be given.Injection fentanyl 1 mcg/kg iv will be given to patients who do not respond to in paracetamol 1 gm iv .Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation. |