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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [iamprajjal94@gmail.com].

  6. 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.

  7. 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.


 
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