NCT07180979

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
7mo left

Started Mar 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

February 2, 2026

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 12, 2025

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

    morphine milligram equivalents (MME)

    first 48 hours postoperatively

Secondary Outcomes (11)

  • Pain scores

    4 hours after surgery

  • Pain scores

    8 hours after surgery

  • Pain scores

    12 hours after surgery

  • Pain scores

    24 hours after surgery

  • Pain scores

    48 hours after surgery

  • +6 more secondary outcomes

Study Arms (3)

Control group

PLACEBO COMPARATOR

All participants will receive standard spinal anesthesia for total hip arthroplasty and multimodal postoperative analgesia according to institutional protocol.

Drug: Ropivacaine 0.5% Injectable Solution

PENG + LFCN

ACTIVE COMPARATOR

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.

Drug: Ropivacaine 0.2% Injectable Solution

L-ESPB + S-ESPB

ACTIVE COMPARATOR

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.

Drug: Ropivacaine 0.2% Injectable Solution

Interventions

All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.

Also known as: Spinal Anesthesia
Control group

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.

PENG + LFCN

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

RopivacaineAnesthesia, Spinal

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Malgorzata Reysner

    Poznan University of Medical Sciences

    STUDY CHAIR
  • Tomasz Reysenr, M.D.

    Poznan Univesity of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Malgorzata Reysner, M.D. Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

February 2, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share