| CTRI Number |
CTRI/2024/10/074934 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In 18-70 years old patients undergoing hip surgery,to compare the analgesic efficacy of programmed intermittent bolus vs continuous infusion in pericapsular nerve group block for 24 hours post operative period. |
|
Scientific Title of Study
|
A comparative study to evaluate the analgesic efficacy of programmed intermittent bolus vs continuous infusion in pericapsular nerve group block
for post operative analgesia in patients undergoing hip surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Maurya |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Lady Hardinge Medical College Delhi |
| Address |
Department of Anaesthesia,Lady hardinge medical college connaught place delhi 110001
Central
DELHI
110001
India |
| Phone |
8285726255 |
| Fax |
|
| Email |
ravimorya7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
Lady hardinge medical college and associated hospitals Delhi 110001 |
| Address |
Department of Anaesthesia, Lady hardinge medical college shaheed bhagat singh marg ,DIZ area,Connaught place, delhi 110001
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Hayaran |
| Designation |
Professor |
| Affiliation |
Lady hardinge medical college and associated hospitals Delhi 110001 |
| Address |
Department of Anaesthesia,Lady hardinge medical college shaheed bhagat singh marg ,DIZ area,Connaught place, delhi 110001
Central
DELHI
110001
India |
| Phone |
9873903603 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical college Shaheed bhagat singh marg ,DIZ area ,connaught place delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady hardinge medical college |
| Address |
Department of anaesthesia lady hardinge medical college shahid bhagat singh marg,Delhi 110001 |
| 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 Ravi Maurya |
Lady hardinge medical college |
Department of Anaesthesia,Lady hardinge medical college, DIZ area,shaheed bhagat singh marg,Connaught place,delhi 110001
Central
DELHI |
8285726255
ravimorya7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitte for human research LHMC and associated hospitals |
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 |
0.125% Bupivacaine in continuous infusion. |
10ml of 0.125% bupivacaine bolus every hourly via cadd-solis 2110 ambulatory infusion set and 2 ml of 0.125% bupivacaine bolus on having pain with lock out interval of 15 min in continuous infusion for 24 hours in pericapsular nerve group block for postoperative analgesia in patients undergoing hip surgery. |
| Intervention |
0.125% Bupivacaine in programmed intermittent bolus. |
10ml of 0.125% bupivacaine bolus every hourly via cadd-solis 2110 ambulatory infusion set and 2 ml of 0.125% bupivacaine bolus on having pain with lock out interval of 15 min in programmed intermittent bolus for 24 hours in pericapsular nerve group block for postoperative analgesia in patients undergoing hip surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults patients ASA1 and ASA2 18-70 years posted for hip fixation surgery. |
|
| ExclusionCriteria |
| Details |
Any known drug allergies.
Contraindications to nerve block like bleeding diathesis and local infection.
Patients requires general anaesthesia during surgey. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean drug consumption in ml at the end of 24 hrs postopertively in both programmed intermittent bolus and continuous infusion n pericapsular nerve group block for analgesia. |
24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Median NRS on rest pain at 0,4,8,12 and 24hours postoperatively
Rescue Analgesia (morphine equivalent) in mg/kg 24hrs postoperatively .
Median patient satisfaction.
Proportion of patients devloping complications. |
24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/10/2024 |
| 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="1"
Days="18" |
|
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
|
Hip fixation surgery is definitive management for hip fracture. However pain after hip surgery can significantly increase both, the postoperative complications and morbidity which delay recovery. Various methods have been described for providing postoperative analgesia after hip surgery. Intravenous patient controlled analgesia or epidural analgesia is most common method, but it is associated with inadequate analgesia and opioid associated complications. In 2018,Giron-Arango et al described ultrasound guided pericapsular nerve group block(PENG) following hip fixation surgery. Many studies indicated that PANG block could provide sufficient analgesia with no to minimal opioid requirements in post operative period .It blocks the articular branches of femoral, obturator and accessory obturator nerve that provide sensory innervation to anterior hip capsule. Many studies have been done in continuous infusion but there is limited literature on the programmed intermittent bolus method for postoperative analgesia via pericapsular nerve group block. |