| CTRI Number |
CTRI/2024/08/072387 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to study the comparison of ultrasound guided pericapsular nerve group block with or without clonidine. |
|
Scientific Title of Study
|
Comparison of USG-guided pericapsular nerve group block with or without adjuvant-clonidine as perioperative analgesia in patients undergoing hip surgeries under spinal anaesthesia: randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal krishan Jalwal |
| Designation |
Assistant professor |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room no-143, OT complex, first floor, IPD building, Department of anaesthesia, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gopal krishan Jalwal |
| Designation |
Assistant professor |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room no-143, OT complex, first floor, IPD building, Department of Anaesthesia, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gopal krishan Jalwal |
| Designation |
Assistant professor |
| Affiliation |
AIIMS BATHINDA |
| Address |
Room no-143, OT complex, first floor, IPD building, Department of Anaesthesia, AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
7838939833 |
| Fax |
|
| Email |
gopaljalwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia office, IPD first floor, near OT complex, Department of Anaesthesia, AIIMS Bathinda, Punjab-151001, INDIA |
|
|
Primary Sponsor
|
| Name |
Gopal krishan jalwal |
| Address |
Room no-143, OT complex, first floor, IPD building, AIIMS Bathinda |
| 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 |
| gopal krishan jalwal |
AIIMS BATHINDA |
Room no. 143, near OT complex, IPD first floor, Department of Anaesthesia
Bathinda
PUNJAB
Bathinda
PUNJAB |
7838939833
gopaljalwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,AIIMS Bathinda,Punjab-151001 |
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 |
PENG block ropivacaine with clonidine |
the patient will be given Pericapsular nerve group block ( PENG) with a single injection of ropivacaine 0.2% (20ml) with clonidine (1mcg/kg) 20 minutes before surgical procedure. |
| Intervention |
PENG block with ropivacaine |
patient will be given Pericapsular nerve group block ( PENG) with single injection rovivacaine 0.2% 20 minutes before surgical surgical procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex in the age group of 18 to 70 years with physical status ASA1 or ASA II |
|
| ExclusionCriteria |
| Details |
Consent refusal, Allergic history to local anaesthetic, abnormal coagulation profile, emergency surgeries, contraindications to regional anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome TimePoints
To evaluate the time to first analgesic request postoperatively. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To calculate the Ease of spinal positioning score after performing the block for positioning of spinal anaesthesia
2) To determine numerical rating scale pain scores at rest and at 15 degree leg elevation in both the groups
3) To determine the total dose of analgesic requirement in the first 24 hours after surgery in both the patients group |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Hip surgery is very painful surgery and is done under spinal anaesthesia. to perform spinal anaesthesia, we have to make positioning either sitting or lateral that poses significant pain. Pericapsular nerve group block is performed in a supine position before spinal anaesthesia to provide analgesia for ease of positioning of spinal anaesthesia as well as for postoperative analgesia. it only blocks articular branches of the hip joint without involving the motor supply of quadriceps muscles. This study is to conduct the comparison of USG-guided pericapsular nerve group block with or without adjuvant-clonidine as perioperative analgesia in patients posted for hip surgeries under spinal anaesthesia |