CTRI Number |
CTRI/2021/07/034895 [Registered on: 15/07/2021] Trial Registered Prospectively |
Last Modified On: |
14/07/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of pain relief between ultrasound guided continuous pericapsular nerve group block and lumbar plexus block after undergoing surgery for unilateral hip fracture. |
Scientific Title of Study
|
Continuous ultrasound Pericapsular nerve group block in comparison with ultrasound lumbar plexus block for postoperative pain Management in unilateral hip fracture: A Prospective, randomised, single blind controlled trial study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pelerieto Rurhia |
Designation |
Post Graduate Junior Resident |
Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH |
Address |
Department of Anaesthesia and Intensive Care GMCH Chandigarh Sector 32 Chandigarh Chandigarh CHANDIGARH 160030 India |
Phone |
07005859684 |
Fax |
|
Email |
pelerieto007@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Sukanya Mitra |
Designation |
Professor and Head |
Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH |
Address |
Department of Anaesthesia and Intensive Care GMCH Chandigarh Sector 32 Chandigarh Chandigarh CHANDIGARH 160030 India |
Phone |
9646121521 |
Fax |
|
Email |
drsmitra12@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Prof Sukanya Mitra |
Designation |
Professor and Head |
Affiliation |
GOVERNMENT MEDICAL COLLEGE HOSPITAL CHANDIGARH |
Address |
Department of Anaesthesia and Intensive Care GMCH Chandigarh Sector 32 Chandigarh
CHANDIGARH 160030 India |
Phone |
9646121521 |
Fax |
|
Email |
drsmitra12@yahoo.com |
|
Source of Monetary or Material Support
|
Government Medical College and Hospital Chandigarh |
|
Primary Sponsor
|
Name |
Government Medical College and Hospital Chandigarh |
Address |
Department of Anaesthesia and Intensive care Level 5 D block Government Medical College and Hospital |
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 Pelerieto Rurhia |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive Care GMCH Chandigarh Chandigarh CHANDIGARH |
07005859684
pelerieto007@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition:S798||Other specified injuries of hip and thigh. Ayurveda Condition: Not Applicable, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Analgesic efficacy of continuous ultrasound lumbar plexus block for unilateral hip fracture surgery. |
Patient will be given 0.5% of Ropivacaine (15 ml bolus) plus 2 microgram/ml fentanyl will be
injected and the infiltration visualised on the screen simultaneously. The nerve root also gets
delineated better after the injection of the local anaesthetic. Stimulus will be applied on
patient’s skin by applying cold touch and needle prick over contralateral thigh and then on
the thigh of the operative side to compare both the responses. Confirmation will be done by
eliciting the absence of response to pin prick and moist cotton wisp touch. In the
postoperative period all patients will receive continuous background infusion of 5 ml/h of
0.2% of ropivacaine with 2 μg/ml of fentanyl. |
Intervention |
Analgesic efficacy of continuous ultrasound pericapsular nerve group block for unilateral hip fracture surgery. |
Patient will be given 0.5% of Ropivacaine
(15 ml bolus) plus 2 microgram/ml fentanyl will be injected. A catheter will be inserted 3 cm
beyond the needle tip, and an injection/aspiration test with saline will be performed. The
success of the block will be assessed by pain scores at rest and on dynamic movement of hip
(straight leg raise to 150
, assessment of Quadriceps strength. Block onset time is around 30
minutes and sufficient time needs to elapse before block testing. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
America Society of Anaesthesiologists (ASA) status - I and II
Age between 20 - 80 years
BMI - 18 - 35 kg/m2
Patients undergoing surgery for unilateral hip fracture |
|
ExclusionCriteria |
Details |
Patient refusal
History of drug allergy to ropivacaine and fentanyl
Coagulation disorders
Cardiovascular, respiratory, and neurological illness
Uncontrolled Diabetes Mellitus
Local infection
Systemic infection
Aberrant anatomy of the landmarks
Patients having haemodynamic instability
Pregnancy and lactating mother
Patients who fail to understand pain assessment and usage of PCA pump |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the mean postoperative pain score over 48 hours using numeric rating scale in patients receiving PENG block vs lumbar plexus block |
5 mins, 10 mins, 15 mins, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the difference in motor power and patient satisfaction within the two groups and also note adverse effects, if any, in both groups |
5 mins, 10 mins, 20 mins, 4 hours, at 2 hour intervals till 24 hours, 36 hours, and 48 hours |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
03/08/2021 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The postoperative pain relief of the patients undergoing surgery for unilateral hip fracture can be done by various techniques. Multiple trials and a systematic review have described decrease in pain scores and opioid consumption while comparing postoperative regional analgesia to systemic analgesia. Regional anaesthesia is considered one of the safer modes in elderly patients to alleviate postoperative morbidity and mortality. Lumbar plexus block (psoas compartment block) under ultrasound guidance is a novel important modality for providing pain relief in hip fracture surgeries. One of the difficulties of effective regional analgesia of hip pain is the complex innervation of the joint. Sensory innervation of anterior capsule of hip includes articular branches of femoral, obturator and accessory obturator nerve, with a greater contribution by the high branches of femoral nerve. Pericapsular nerve group block (PENG) is a novel regional analgesia technique for postoperative pain management of hip fracture. It was first described (PENG) block in 2018 by using a low frequency curvilinear ultrasound probe to deposit local anaesthetic in the 2 musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. It was successfully demonstrated that PENG block reduced pain score by a median of 7 points on a 10 points numerical rating scale in patients with hip fracture. PENG block is primarily ultrasound guided which targets the articular branches of femoral nerve, accessory obturator nerve. PENG block is also used for surgical anaesthesia to reduce dislocated hip, striping of varicose vein. The major limiting factor for PENG block is the use of ultrasound as it is not yet available to everyone particularly in developing countries. The present study aims to evaluate the effectiveness, efficacy and safety of PENG block in comparison with lumbar plexus block for postoperative pain management of hip fracture. |