| CTRI Number |
CTRI/2026/03/106479 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| 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
|
Comparision between Dexamethasone and Clonidine as an Adjuvant to 0.5% Ropivacaine in Ultrasound Guided Pericapsular Nerve Group Block on Peri-operative Analgesia Among Patients Undergoing Total Hip Replacement Surgery at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Comparision between Dexamethasone and Clonidine as an Adjuvant to zero point 5 percent Ropivacaine in Ultrasound Guided Pericapsular Nerve Group Block on Peri-operative Analgesia Among Patients Undergoing Total Hip Replacement Surgery at a Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATEEKSHA S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES-VIJAYPUR,JAMMU |
| Address |
Aiims, Jammu
Department of Anaesthesiology, Aiims, Jammu and Kashmir, 184120
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9483742625 |
| Fax |
|
| Email |
prateeksha.srinivas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHRUTI SHARMA |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medicals Sciences, Jammu |
| Address |
Department of Anaesthesiology, Aiims,Jammu and Kashmir, 184120
Department of Anaesthesiology, Aiims,Jammu and Kashmir, 184120
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9419163183 |
| Fax |
|
| Email |
shruti.sharma@aiimsjammu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
PRATEEKSHA S |
| Designation |
Post Graduate Student |
| Affiliation |
All India Institute of Medical Sciences, Jammu |
| Address |
Department of Anaesthesiology, Aiims,Jammu and Kashmir, 184120
Department of Anaesthesiology, Aiims,Jammu and Kashmir, 184120
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9483742625 |
| Fax |
|
| Email |
prateeksha.srinivas@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences,Vijaypur,Jammu and Kashmir, India , 184120 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jammu |
| Address |
Department of Anaesthesiology, Aiims,Jammu and Kashmir, 184120 |
| 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 |
| Dr Prateeksha S |
All India Institute of Medical Sciences |
Department of Anesthesiology, AIIMS, Jammu and Kashmir, 184120
Jammu
JAMMU & KASHMIR |
9483742625
prateeksha.srinivas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIIMS Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
USG-guided PENG block with 20 ml of 0.5% Ropivacaine + Clonidine |
USG-guided PENG block with 20 ml of 0.5% Ropivacaine + Clonidine.Block is performed supine using a 2–5 MHz curvilinear probe. The drug is injected into the plane between the psoas tendon and pubic ramus in 5-ml increments.We will assess pain levels using the Numeric
Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at
4, 8, 12, 18 and 24 hours after the surgery |
| Intervention |
USG-guided PENG block with 20 ml of 0.5% Ropivacaine + Dexamethasone. |
USG-guided PENG block with 20 ml of 0.5% Ropivacaine + Dexamethasone.Block is performed supine using a 2–5 MHz curvilinear probe. The drug is injected into the plane between the psoas tendon and pubic ramus in 5-ml increments.We will assess pain levels using the Numeric
Rating Scale (NRS) at rest and with 15° leg elevation in the PACU, as well as at
4, 8, 12, 18 and 24 hours after the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of any gender
Subjects aged between 18 to 70 years
Subjects with American Society of Anaesthesiologists status one and two who are
planned for hip surgeries. |
|
| ExclusionCriteria |
| Details |
patient refusal
pregnant women and pediatric population
use of chronic opioids
a history of preexisting neuropathies, seizures, previous neurological deficits
those with severe chronic obstructive pulmonary disease
coagulopathy
body mass index more than or equal to 35kg msquare
history of allergy
contradiction to any drugs involved in this study
a history of other chronic pain diseases
skin rupture and infection at the puncture site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time required for first rescue analgesia between Dexamethasone and Clonidine as adjuvants to 0.5% Ropivacaine in ultrasound-guided Pericapsular Nerve Group (PENG) block among patients undergoing total hip replacement surgery. |
4hours, 8hours, 12 hours, 18 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the Ease Of Spinal Positioning (EOSP) between both adjuvants after PENG block, for spinal anaesthesia.
2)To determine Numerical Rating Scale pain Scores at rest & at 15° leg elevation in both the groups undergoing the respective blocks at first 4,8,12,18,24 hours in the post operative period.
3) To determine the total dose of rescue analgesic requirement in the first 24 hours after surgery in both patient groups. |
4 hours, 8 hours,12 hours,18 hours,24 hours in the post operative period.
|
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
29/03/2026 |
| 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="2"
Months="0"
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
|
This study is a prospective randomized controlled trial designed to compare the efficacy of dexamethasone versus clonidine as adjuvants to point five per cent ropivacaine in ultrasound guided Pericapsular Nerve Group block for perioperative analgesia in patients undergoing total hip replacement surgery. A total of 52 patients belonging to ASA class 1 and 2 and aged between 18 and 70 years will be included. Participants will be randomly allocated into two groups using computer generated block randomisation. Group A will receive ropivacaine with dexamethasone
Group B will receive ropivacaine with clonidine The primary outcome measure is the time to first rescue analgesia. Secondary outcome measures include ease of spinal positioning postoperative pain scores using a numeric rating scale at rest and at 15 degree leg elevation at multiple time intervals up to 24 hours and total analgesic consumption in the first 24 hours. All patients will receive standardized spinal anesthesia and postoperative analgesia with paracetamol and fentanyl as rescue analgesic when required. The study will be conducted over a period of 18 months at AIIMS Jammu. Statistical analysis will be performed using appropriate tests as per objective The aim of the study is to identify the better adjuvant that prolongs duration of analgesia reduces opioid requirement and improves perioperative pain management in patients undergoing hip surgery. |