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Efficacy of Pericapsular Nerve Group Block

Primary Purpose

Acute Pain

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Pericapsular Nerve Group Block
Fascia iliaca compartment block
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II
  • Age 18 or above
  • Scheduled for hip fracture corrective surgery in Queen Mary Hospital
  • Chinese patients
  • Able to provide informed oral and written consent
  • Abbreviated Mental Test (AMT) 7 or above

Exclusion Criteria:

  • Patient refusal
  • ASA III or above
  • Allergy to local anaesthetics, opioids, paracetamol, NSAID including COX-2 inhibitors
  • Operation delayed for more than 2 days on admission
  • Pre-existing peripheral neuropathy or history of stroke
  • Preoperative non-walker
  • Pre-existing osteoarthritis of knee (KL grade 4)
  • Multiple fractures (additional to hip fracture)
  • Sepsis
  • Impaired renal function (Defined as preoperative creatinine level >120 μmol or eGFR <50% of normal reference for their age group
  • Patient with coagulopathy (Platelet < 100 or INR >1.5)
  • Prior surgery at the inguinal or supra-inguinal area

Sites / Locations

  • Timmy ChanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pericapsular Nerve Group Block

Fascia iliaca compartment block

Arm Description

30ml 0.3% Ropivacaine will be injected between psoas muscle and iliopubic eminence.

30ml 0.3% Ropivacaine will be injected into fascia iliaca compartment.

Outcomes

Primary Outcome Measures

Pain score at rest on postoperative day 1
Measure pain score at rest using numerical rating scale from 0 to 10, where 0 is no pain and 10 is the worst pain

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
October 31, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05154318
Brief Title
Efficacy of Pericapsular Nerve Group Block
Official Title
Study Comparing the Efficacy of Pericapsular Nerve Group (PENG) Block and Facia Iliaca Compartment Block (FICB) in Hip Fracture - A Prospective Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip fracture is a common orthpaedic problem especially in elderly population. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Reviews have shown peripheral nerve blocks including FICB, femoral nerve block and 3-in-1 block could reduce both pain and opioid consumption compared with systematic analgesia. However, there are also literature suggesting that some nerves that account for the major hip joint sensory innervation are not consistently covered. As a result, a new ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018. The primary aim of this study is to compare the analgesic effect of PENG block and FICB in terms of pain score during post-operative period. It also compares the range of movement, quadriceps power and other parameters related to physical functions of the operated hip as secondary outcomes.
Detailed Description
Hip fracture is a common orthopaedic problem especially in elderly population. The number of hip fractures each year is expected to double from 2.2 million in 2017 to 4.5 million in 2050. It is the commonest reason for elderly to require hospitalisation and emergency operation. Significant morbidities such as pulmonary embolism, pneumonia and bed sore can be resulted from immobility and pain. Hip fracture also contributes to post-operative mortality at a rate about 8% at 1 month and 30% at 1 year. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Cochrane review has shown peripheral nerve blocks including FICB, Femoral nerve block and 3-in-1 block could reduce both pain at 30 minute and opioid consumption compared with systemic analgesia. In particular, FICB is found to be superior to opioids for pain control on movement, preoperative analgesic consumption, time to first analgesic request, and time to perform spinal anaesthesia. However, literature suggests that the obturator nerve is not consistently covered. The anterior hip capsule which contributes the major hip joint sensory innervation is supplied by femoral nerve (FN), obturator nerve (ON) and accessory obturator nerve (AON). As a result, a novel ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018, targeting the above 3 nerves. This is very important as the obturator nerve is also blocked with this technique. Case reports showed reduction in pain scores compared with baseline 30 minutes after block placement and no clinically evident quadriceps weakness was detected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular Nerve Group Block
Arm Type
Experimental
Arm Description
30ml 0.3% Ropivacaine will be injected between psoas muscle and iliopubic eminence.
Arm Title
Fascia iliaca compartment block
Arm Type
Active Comparator
Arm Description
30ml 0.3% Ropivacaine will be injected into fascia iliaca compartment.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular Nerve Group Block
Intervention Description
Nerve block targeting major hip joint sensory nerves.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
Routine nerve block for hip fracture surgery.
Primary Outcome Measure Information:
Title
Pain score at rest on postoperative day 1
Description
Measure pain score at rest using numerical rating scale from 0 to 10, where 0 is no pain and 10 is the worst pain
Time Frame
on postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II Age 18 or above Scheduled for hip fracture corrective surgery in Queen Mary Hospital Chinese patients Able to provide informed oral and written consent Abbreviated Mental Test (AMT) 7 or above Exclusion Criteria: Patient refusal ASA III or above Allergy to local anaesthetics, opioids, paracetamol, NSAID including COX-2 inhibitors Operation delayed for more than 2 days on admission Pre-existing peripheral neuropathy or history of stroke Preoperative non-walker Pre-existing osteoarthritis of knee (KL grade 4) Multiple fractures (additional to hip fracture) Sepsis Impaired renal function (Defined as preoperative creatinine level >120 μmol or eGFR <50% of normal reference for their age group Patient with coagulopathy (Platelet < 100 or INR >1.5) Prior surgery at the inguinal or supra-inguinal area
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timmy CW Chan, MBBS
Phone
22555679
Email
timmychancw@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timmy CW Chan, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Timmy Chan
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timmy Chan, MBBS
Phone
22555791
Email
timmychancw@gmail.com

12. IPD Sharing Statement

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Efficacy of Pericapsular Nerve Group Block

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