| CTRI Number |
CTRI/2026/02/102984 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two types of PENG nerve blocks for better pain relief after hip surgery |
|
Scientific Title of Study
|
A Randomized Clinical Trial Evaluating Ultrasound-Guided Pericapsular Nerve Block (PENG) with Dexmedetomidine-Adjuvanted Ropivacaine Versus Plain Ropivacaine for Prolonged Pain Relief in Hip Surgery Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajjal Das |
| Designation |
Senior Resident |
| Affiliation |
Uttar pradesh University of medical sciences |
| Address |
Department of Anaesthesiology , Uttarpradesh University of medical
Sciences , Saifai , Etawah
Etawah UTTAR PRADESH 206130 India |
| Phone |
9369167560 |
| Fax |
|
| Email |
iamprajjal94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Usha Shukla |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Anaesthesia , Uttarpradesh University of Medical sciences , Saifai
Etawah UTTAR PRADESH 206130 India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Usha Shukla |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Anaesthesia , Uttarpradesh University of Medical sciences , Saifai
UTTAR PRADESH 206130 India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar pradesh University of Medical sciences , saifai , Etawah , Uttar pradesh , India- 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh university of Medical Sciences |
| Address |
Uttar Pradesh university of medical sciences , Saifai , Etawah , India -206130 |
| 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 |
| Prajjal Das |
Uttar pradesh university of medical sciences |
Department of Anesthesiology, Saifai , Etawah Etawah UTTAR PRADESH |
9369167560
iamprajjal94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S799||Unspecified injury of hip and thigh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine- Adjuvanted Ropivacaine |
Inj.Ropivacaine 0.25% 20ml + Inj.Dexmeditomedine 0.5mcg/kg |
| Comparator Agent |
Plain Ropivacaine |
Inj. Ropivacaine 0.25% 20ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients of age 18 tp 75 years of both gender scheduled for hip surgery lasting upto 3 hours under regional or general anesthesia.
2. American Society of Anesthesiologists physical status 1 to 3
3. Ability to report pain scores using the Numeric Rating Scale |
|
| ExclusionCriteria |
| Details |
1. Allergy to ropivacaine or dexmedetomidine.
2. Contraindications to regional anesthesia
3. Pre-existing chronic pain conditions.
4. Severe hepatic or renal impairment
5. Cognitive impairment or inability to comply with pain assessments.
6. Refusal to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine whether dexmedetomidine-adjuvanted ropivacaine in ultrasound-guided PENG block significantly prolongs the duration of analgesia compared to plain ropivacaine in hip surgery patients.
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the total analgesic consumption between the two groups in the first 24 hours post-block and need for first rescue analgesia
2. To assess differences in pain scores (using the Numeric Rating Scale, NRS) at 0, 2 , 4, 6, 12, 24 hours post-block
3. To investigate the impact of the PENG block on patient satisfaction using Likert scale.
4. To compare hemodynamic parameters
5.To evaluate the incidence of adverse events |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
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)
|
20/02/2026 |
| 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="1" Months="6" 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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 - Proposals should be directed to [iamprajjal94@gmail.com].
- For how long will this data be available start date provided 02-12-2026 and end date provided 02-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective randomized controlled study includes 60 patients aged 18–75 years, belonging to ASA physical status I–III, scheduled for elective hip surgery. After institutional ethical committee approval and obtaining written informed consent, patients will be randomized using a computer-generated random table with concealed envelope technique into two groups: Group DR (n=30) receiving ultrasound-guided PENG block with 20 ml of 0.25% ropivacaine plus dexmedetomidine 0.5 µg/kg, and Group R (n=30) receiving 20 ml of 0.25% ropivacaine alone. All patients will be educated preoperatively regarding pain assessment using the Numeric Rating Scale and satisfaction using the Likert scale, and will undergo pre-anaesthetic evaluation a day prior to surgery. After standard fasting, patients will be monitored intraoperatively with ASA standard monitors, intravenous access will be secured, and Ringer lactate will be started at 10 ml/kg. Under aseptic precautions and ultrasound guidance, the PENG block will be performed preoperatively by injecting the assigned drug into the musculofascial plane between the psoas tendon and pubic ramus. Subsequently, all patients will receive subarachnoid block at L2–L5 interspace using a 25G Quincke needle with 0.5% hyperbaric bupivacaine at a dose of 0.3 mg/kg. Hemodynamic parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded at baseline and perioperatively, and patients will be monitored and managed for complications such as hypotension, bradycardia, or local anesthetic systemic toxicity.
|