PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty

NCT ID: NCT07180979

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-11-30

Brief Summary

The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.

The main questions it aims to answer are:

Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery.

Participants will:

Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.

Detailed Description

Total hip arthroplasty (THA) is associated with moderate-to-severe postoperative pain, which can impair early mobilization and functional recovery. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block and the erector spinae plane (ESP) block, have been introduced as motor-sparing alternatives to femoral and lumbar plexus blocks. The PENG block targets articular branches of the femoral, obturator, and accessory obturator nerves, offering effective analgesia with minimal motor blockade. Meanwhile, the lumbar ESPB (L-ESPB) and sacral ESPB (S-ESPB) may provide a broader, yet still motor-sparing, analgesic field by targeting both lumbar and sacral nerve roots involved in hip innervation.

To date, no randomized trial has compared PENG with a dual-level ESP block approach (L-ESPB + S-ESPB) in THA patients.

Conditions

Hip Osteoarthritis; Hip Arthropathy; Hip Pain Chronic

Study Design

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

Study Groups

Control group

Participants in this group will undergo simulated (sham) regional anesthesia procedures at the anatomical sites corresponding to both intervention techniques (pericapsular + lateral femoral cutaneous nerve \[LFCN\] block locations, and lumbar/sacral erector spinae plane block locations). Under ultrasound guidance, a needle will be introduced to each site, but only 1-2 mL of normal saline will be injected to mimic the sensation of an active block without delivering local anesthetic. All participants will receive standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia according to institutional protocol.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium chloride

Intervention Type: DRUG

Sham ultrasound-guided pericapsular nerve group (PENG) block, lateral femoral cutaneous nerve (LFCN) block, lumbar erector spinae plane block (L-ESPB), and sacral erector spinae plane block (S-ESPB).

At each anatomical site, under ultrasound guidance, a block needle will be inserted to the correct position, and 1-2 mL of preservative-free normal saline (0.9% NaCl) will be injected to mimic the sensation of an active block. No local anesthetic will be administered. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

PENG + LFCN

Participants in this group will receive an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block using local anesthetic. To preserve blinding, sham procedures will be performed at the lumbar and sacral erector spinae plane block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be administered as per institutional protocol.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Ultrasound-guided pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, with sham lumbar and sacral ESPBs.

PENG block: 20 mL of 0.2% ropivacaine. LFCN block: 5 mL of 0.2% ropivacaine. Sham lumbar ESPB: 1-2 mL preservative-free normal saline at lumbar ESPB site. Sham sacral ESPB: 1-2 mL preservative-free normal saline at sacral ESPB site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

L-ESPB + S-ESPB

Participants in this group will receive ultrasound-guided lumbar erector spinae plane block (L-ESPB) combined with sacral erector spinae plane block (S-ESPB) using local anesthetic. To preserve blinding, sham procedures will be performed at the pericapsular and lateral femoral cutaneous nerve block sites (needle insertion and injection of 1-2 mL normal saline). Standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia will be provided according to institutional protocol.

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Ultrasound-guided lumbar erector spinae plane block (L-ESPB) and sacral erector spinae plane block (S-ESPB), with sham PENG and LFCN blocks.

Lumbar ESPB: 20 mL of 0.2% ropivacaine at L3 transverse process level. Sacral ESPB: 20 mL of 0.2% ropivacaine at sacral intermediate crest. Sham PENG block: 1-2 mL preservative-free normal saline at PENG site. Sham LFCN block: 1-2 mL preservative-free normal saline at LFCN site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

Interventions

0.9% Sodium chloride

Sham ultrasound-guided pericapsular nerve group (PENG) block, lateral femoral cutaneous nerve (LFCN) block, lumbar erector spinae plane block (L-ESPB), and sacral erector spinae plane block (S-ESPB).

At each anatomical site, under ultrasound guidance, a block needle will be inserted to the correct position, and 1-2 mL of preservative-free normal saline (0.9% NaCl) will be injected to mimic the sensation of an active block. No local anesthetic will be administered. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

Intervention Type: DRUG

Ropivacaine 0.2% Injectable Solution

Ultrasound-guided pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, with sham lumbar and sacral ESPBs.

PENG block: 20 mL of 0.2% ropivacaine. LFCN block: 5 mL of 0.2% ropivacaine. Sham lumbar ESPB: 1-2 mL preservative-free normal saline at lumbar ESPB site. Sham sacral ESPB: 1-2 mL preservative-free normal saline at sacral ESPB site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

Intervention Type: DRUG

Ropivacaine 0.2% Injectable Solution

Ultrasound-guided lumbar erector spinae plane block (L-ESPB) and sacral erector spinae plane block (S-ESPB), with sham PENG and LFCN blocks.

Lumbar ESPB: 20 mL of 0.2% ropivacaine at L3 transverse process level. Sacral ESPB: 20 mL of 0.2% ropivacaine at sacral intermediate crest. Sham PENG block: 1-2 mL preservative-free normal saline at PENG site. Sham LFCN block: 1-2 mL preservative-free normal saline at LFCN site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

Intervention Type: DRUG

Other Intervention Names

Sham block

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years
• ASA physical status I-III
• Elective unilateral THA via posterior or lateral approach
• Informed consent provided

Exclusion Criteria

• Allergy to study drugs (ropivacaine, dexamethasone)
• Chronic opioid use (>30 MME/day)
• Coagulopathy or infection at the injection site
• BMI > 40 kg/m²
• Pre-existing motor weakness or neuropathy in the affected limb
• Cognitive impairment precluding informed consent

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malgorzata Reysner

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Tomasz Reysenr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Poznan Univesity of Medical Sciences

Central Contacts

Malgorzata Reysner, M.D. Ph.D.

Role: CONTACT

mreysner@ump.edu.pl

+48 61 873 83 03

Other Identifiers

03/2025

Identifier Type: -

Identifier Source: org_study_id