NCT07255768

Brief Summary

In the clinic, total hip arthroplasty is a frequently performed surgical procedure that often results in moderate to severe postoperative pain. Multimodal analgesia approaches are commonly preferred for managing this pain, and in recent years, nerve blocks targeting pelvic innervation have become increasingly prominent. Among these, the Pericapsular Nerve Group (PENG) block has gained attention for providing effective analgesia by targeting the nerves responsible for the anterior innervation of the hip capsule. However, when used alone, the PENG block may be insufficient for controlling posterior hip pain and may not provide complete analgesia. In this context, adding blocks targeting the superior cluneal nerve and the superior gluteal nerve-both of which contribute to the sensory innervation of the posterior hip region-has been proposed to enhance the analgesic effect when combined with the PENG block. Superior cluneal and superior gluteal nerve blocks have recently been described in anatomical and clinical studies, and by affecting the structures contributing sensory input to the posterior hip capsule, they hold significant potential for improving pain management. In this study, the investigators aimed to evaluate the contribution of superior cluneal and superior gluteal nerve blocks, when added to the PENG block, to perioperative analgesia in patients undergoing total hip arthroplasty. The investigators sought to comparatively investigate whether this combination offers superior outcomes compared with the PENG block alone. It was hypothesized that combined nerve blocks may provide similar or improved recovery scores, lower pain scores, reduced opioid consumption, and enhanced analgesic efficacy without affecting the degree of motor blockade.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

November 16, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • QoR-15 (Quality of Recovery-15) questionnaire

    The primary outcome measure will be the QoR-15 (Quality of Recovery-15) questionnaire administered at the 24th postoperative hour. QoR-15 is a validated 15-item short survey assessing patients' postoperative physical comfort, emotional state, level of independence, pain control, and overall well-being. The total score obtained will be used to compare the overall quality of recovery between groups. The same questionnaire will be repeated at the 48th postoperative hour.

    24th and 48th postoperative hour

Secondary Outcomes (4)

  • Quadriceps Motor Block Assessment

    It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.

  • Motor Block Assessment at the Tibialis Anterior Muscle for the Sciatic Nerve

    It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.

  • Fentanyl consumption

    The first 24 postoperative hours

  • VAS pain scores

    The first 24 postoperative hours

Study Arms (2)

Application of PENG Block

ACTIVE COMPARATOR

Patients will be brought to the operating room one hour before surgery, and no premedication will be administered prior to their arrival. Before performing the PENG block, patients will be placed in the supine position. The ultrasound probe will be positioned in the transverse plane medial and caudal to the anterior superior iliac spine, and the anterior inferior iliac spine, iliopubic eminence, and psoas tendon will be identified. Using an in-plane technique, the needle will be advanced from lateral to medial and positioned between the psoas tendon and the periosteum. After negative aspiration, 15 mL of 0.25% bupivacaine will be administered.

Drug: 15 ml Bupivacaine Hcl 0.25% injectionDrug: 20 mL bupivacaine 0.25% injection

Application of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks

ACTIVE COMPARATOR

All patients will receive a PENG block, and in addition: The superior cluneal nerve block will be performed at the level of the posterior iliac crest under ultrasound guidance, along the course of the nerve, using 10 mL of 0.25% bupivacaine. The superior gluteal nerve block will be administered in the lateral decubitus position under ultrasound guidance, with 10 mL of 0.25% bupivacaine injected between the gluteal muscles along the trajectory of the nerve.

Drug: 20 mL bupivacaine 0.25% injection

Interventions

For PENG Block, 15 mL of 0.25% bupivacaine will be administered.

Application of PENG Block

After performing PENG; 10 mL of 0.25% bupivacaine will be administered for each superior cluneal nerve block and superior gluteal nerve block

Application of PENG BlockApplication of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation in the study
  • Age between 18 and 80 years
  • ASA physical status I, II, or III
  • Male or female patients

You may not qualify if:

  • Refusal to participate in the study
  • Allergy to the medications to be used
  • History of severe cardiac, renal, or hepatic disease
  • Presence of neurological deficits or neuropathy
  • History of anticoagulant use
  • Previous surgery in the inguinal or suprainguinal region
  • Pregnancy
  • Chronic opioid use at home
  • History of spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, HipLegg-Calve-Perthes DiseaseFemur Head Necrosis

Interventions

BupivacaineInjections

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 1, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations