Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

NCT04426045 | Completed DMC

• 1 other identifier: 4-2020-0417
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.

Conditions

Total Hip Arthroplasty; Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• Numeric rating scale pain score

  Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

  1 hour after the surgery

• Numeric rating scale pain score

  Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

  6 hours after the surgery

• Numeric rating scale pain score

  Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

  24 hours after the surgery

• Numeric rating scale pain score

  Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

  36 hours after the surgery

• Numeric rating scale pain score

  Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)

  48 hours after the surgery

Secondary Outcomes (4)

• Quadriceps muscle strength

  baseline

• Quadriceps muscle strength

  at 6 hours postoperatively

• Quadriceps muscle strength

  at 24 hours postoperatively

• Quadriceps muscle strength

  at 36 hours postoperatively

Study Arms (2)

Pericapsular nerve group block

EXPERIMENTAL

Participants receiving pericapsular nerve group block

Procedure: Pericapsular nerve group block

Supra-inguinal fascia iliaca compartment block

ACTIVE COMPARATOR

Participants receiving supra-inguinal fascia iliaca compartment block

Procedure: Supra-inguinal fascia iliaca compartment block

Interventions

Pericapsular nerve group block PROCEDURE

A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.2% will be injected.

Also known as: PENG block

Pericapsular nerve group block

Supra-inguinal fascia iliaca compartment block PROCEDURE

A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the "bow-tie sign" formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected.

Also known as: Supra-inguinal FICB

Supra-inguinal fascia iliaca compartment block

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3
• scheduled for elective unilateral total hip arthroplasty

You may not qualify if:

• Allergy or intolerance to any of the drugs used in the study
• Hepatic or renal insufficiency
• Opioid dependency
• Coagulopathy
• Pre-existing neurologic or anatomic deficits in the lower extremities
• Severe psychiatric illness

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 21, 2020
• Primary Completion: June 6, 2021
• Study Completion: June 10, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)