PENG Block for Total Hip Arthroplasty

NCT ID: NCT05944380

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2023-01-30

Brief Summary

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the pericapsular nerve group block on postoperative rehabilitation.

Detailed Description

The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. However, the effect of this block on postoperative rehabilitation is uncertain. This study compares a preoperative PENG block to a placebo before total hip arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

Conditions

Hip Osteoarthritis; Hip Arthropathy; Hip Disease; Hip Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PENG with 20mL 0,5% Ropivacaine

Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.5% ropivacaine. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.5% ropivacaine is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.

Group Type: EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type: DRUG

20 mL 0.5% ropivacaine will be injected for the PENG block

PENG block with 20mL 0,9% normal saline

Patients will receive a preoperative ultrasound-guided pericapsular nerve group block with 20 mL of 0.9% normal saline. Using appropriate sterile precautions and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz) or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the anterior inferior iliac spine, iliopubic eminence, and psoas muscle. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in the plane with the ultrasound beam, beneath the psoas tendon to the iliopubic eminence. 20 mL 0.9% normal saline is injected beneath the psoas tendon and above the iliopubic eminence in 5 mL increments with a periodic aspiration to prevent intravascular injection. The needle is withdrawn, and the needle entry site is wiped clean.

Group Type: EXPERIMENTAL

0,9% normal saline

Intervention Type: DRUG

20 mL 0.9% normal saline will be injected for the PENG block

Interventions

Ropivacaine 0.5% Injectable Solution

20 mL 0.5% ropivacaine will be injected for the PENG block

Intervention Type: DRUG

0,9% normal saline

20 mL 0.9% normal saline will be injected for the PENG block

Intervention Type: DRUG

Other Intervention Names

Ropimol; placebo

Eligibility Criteria

Inclusion Criteria

• Patients > 18 years old undergoing unilateral total hip arthroplasty

Exclusion Criteria

• refusal to participate
• < 18 yo
• Chronic opioid use
• localized infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Małgorzata Domagalska, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

Zbigniew Żaba, PhD

Role: STUDY_CHAIR

Department of Emergency Medicine Clinic

Locations

Poznan Univesity of Medical Sciences

Poznan, Wielkopolska, Poland

Countries

Poland

Other Identifiers

496/20

Identifier Type: -

Identifier Source: org_study_id