Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients

NCT05721924 | Unknown Phase 4

• 1 other identifier: FF-2022-336
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures in and around the hip are common in the elderly and most of them required early surgical fixation. Hip fractures are accompanied with a considerable amount of pain. Based on National Orthopaedic Registry Malaysia (NORM), spinal/neuraxial anaesthesia makes up 66.3%, is the preferred mode of anaesthesia. Severe pain associated with fractured hip often results in difficulty during positioning for neuraxial anaesthesia and hence it is extremely challenging to position the patients in sitting or lateral position for neuraxial anaesthesia procedures. A supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve. It is famous technique among anaesthesiologist to treat immediate and postoperative pain in hip fractures patients. The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. in 2018 for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is an alternative regional anaesthesia technique for the management of acute pain after hip fracture. The goal of this clinical trial is to compare the effectiveness of (PENG) block vs (S-FICB) block in reducing positional pain during neuraxial block in patients going for elective internal fixation of neck of femur fractures. And investigators's hypothesis is PENG block is as effective as S-FICB in reducing positional pain during neuraxial block in patients going for elective internal fixation of neck of femur fractures.

Conditions

Hip Fractures

Keywords

Hip Fractures Patients Going For Internal Fixation

Outcome Measures

Primary Outcomes (1)

• Pain score

  Baseline pain scores (PS0) at rest and on movement (15° passive elevation) as PS0m will be recorded in the data collection sheet before PENG block or S-FICB administration and recorded on numeric pain rating scale (NRS).Pain score will be assessed via numerical pain rating scale (NRS) which the scale is composed of 0 (no pain at all; the best scoring) to 10 (worst imaginable pain; the worst scoring). The pain score will be categorised into mild pain (score of 1-4); moderate pain (score of 5-7) and severe pain (score of 8-10). Pain score will be assessed at 30 minute post bock during rest (PSPB) and on movement at 15° passive elevation (PSPBm). Pain score during positioning during neuraxial anaesthesia also will be recorded.

  30 minutes after intervention

Secondary Outcomes (2)

• Ease of positioning during neuraxial anaesthesia

  30 minutes after intervention

• Patient satisfaction toward the block being given

  30 minutes after neuraxial anaesthesia being given

Study Arms (2)

Pericapsular nerve group (PENG) block

ACTIVE COMPARATOR

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule.

Procedure: Pericapsular nerve group (PENG) block

Supra-inguinal fascia iliaca compartment (S-FICB) block

ACTIVE COMPARATOR

A supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve.

Procedure: Supra-inguinal fascia iliaca compartment (S-FICB) block

Interventions

Pericapsular nerve group (PENG) block PROCEDURE

In PENG group, the patient will be given PENG block 30mls of 0.2% ropivacaine

Pericapsular nerve group (PENG) block

Supra-inguinal fascia iliaca compartment (S-FICB) block PROCEDURE

Patients in group B (S-FICB group) will be supra-inguinal fascia iliaca compartment block 30mls of 0.2% ropivacaine

Supra-inguinal fascia iliaca compartment (S-FICB) block

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II and III
• Hip fractures such as neck of femur (not older than 2 weeks and have persistent pain)

You may not qualify if:

• Patients contraindicated to peripheral nerve blocks
• Patients with history of chronic pain
• Patients with significant cognitive impairment
• Patients with known allergic to study medications

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Siti Nidzwani Mohamad Mahdi Associate Profressor Datin Dr, MBBS

CONTACT

+6012-4210670; nidzwani@yahoo.com

Chong Kok Peng Dr, MD

CONTACT

+60163930729; kokpeng5178@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The recruited patients and the attending anaesthetist will be blinded to the type of block provided for the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The recruited patients will be randomly divided into two groups via stratified randomization based on patient's hips fractures classification. Intra-articular fractures involving fractures within the hip joint. While extra-articular fractures are those fractures outside the capsule of the hip joint which are intertrochanteric and subtrochanteric. Two envelopes will be prepared which is intra-articular and extra-articular fractures envelope. In each envelope, there will be 10 "A" blocks and 10 "B" blocks.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 10, 2023
• Study Start: December 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

MY (1)