NCT07803133

Brief Summary

The goal of this clinical trial is to compare the PENG block with intrathecal morphine for early postoperative recovery and pain control in adults undergoing elective total hip arthroplasty. The main question it aims to answer is: Is there a difference between PENG block and intrathecal morphine in quality of recovery 24 hours after surgery, as measured by the Quality of Recovery-15 (QoR-15) questionnaire? Researchers will also compare postoperative pain, opioid use, mobilization, motor function, and treatment-related side effects between the two groups. Participants will be randomly assigned to receive either a PENG block or intrathecal morphine in addition to spinal anesthesia and standard multimodal pain treatment. Participants will complete the QoR-15 questionnaire before surgery and 24 hours after surgery. Pain scores, opioid use, mobilization, motor function, and side effects will be assessed during the first 24 hours after surgery.

Trial Health

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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
11mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

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 Progress9%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 31, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

Total Hip ArthroplastyPENG BlockIntrathecal MorphineQuality of RecoveryQoR-15Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery-15 (QoR-15) Score at 24 Hours After Surgery

    Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery. The questionnaire will be administered preoperatively to assess baseline recovery status and repeated 24 hours after surgery. The primary outcome will be the QoR-15 score at 24 hours after surgery.

    24 hours after surgery

Secondary Outcomes (10)

  • Pain at Rest Assessed by the Numeric Rating Scale (NRS)

    Preoperatively and at 3, 6, 12, and 24 hours after surgery

  • Pain During Straight Leg Raise Assessed by the Numeric Rating Scale (NRS)

    Preoperatively and at 3, 6, 12, and 24 hours after surgery

  • Cumulative Postoperative Opioid Consumption

    From the end of surgery to 24 hours after surgery

  • Time to First Postoperative Mobilization

    From the end of surgery to first mobilization, assessed up to 24 hours after surgery

  • Overall Benefit of Analgesia Score (OBAS)

    24 hours after surgery

  • +5 more secondary outcomes

Study Arms (2)

PENG Block Group

EXPERIMENTAL

Participants assigned to this group will receive an ultrasound-guided PENG block after spinal anesthesia. The PENG block will have a total injectate volume of 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL. All other perioperative anesthesia and multimodal analgesia will be standardized.

Procedure: Pericapsular nerve group (PENG) block

Intrathecal Morphine Group

EXPERIMENTAL

Participants assigned to this group will receive 100 micrograms of preservative-free intrathecal morphine during spinal anesthesia. All other perioperative anesthesia and multimodal analgesia will be standardized.

Drug: Intrathecal Morphine

Interventions

100 micrograms of preservative-free morphine administered intrathecally during spinal anesthesia

Intrathecal Morphine Group

Participants will receive an ultrasound-guided pericapsular nerve group (PENG) block after spinal anesthesia. The total injectate volume will be 20 mL, with an intended dose of 100 mg bupivacaine (20 mL of 0.5% bupivacaine). The bupivacaine dose will be reduced when necessary to ensure that the total bupivacaine dose, including the dose administered for spinal anesthesia, does not exceed 2 mg/kg. When dose reduction is required, 0.9% saline will be added to maintain a total injectate volume of 20 mL.

PENG Block Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective primary unilateral total hip arthroplasty
  • Planned spinal anesthesia
  • Ability to understand and complete the Quality of Recovery-15 (QoR-15) questionnaire and Numeric Rating Scale (NRS) pain assessments
  • Provision of written informed consent

You may not qualify if:

  • Contraindication to spinal anesthesia or PENG block
  • Known allergy or hypersensitivity to local anesthetics or morphine
  • Coagulation disorder
  • Therapeutic anticoagulant use
  • Infection at the planned injection site
  • Chronic opioid use
  • History of substance abuse
  • Severe cognitive impairment that prevents reliable completion of study assessments
  • Advanced hepatic or renal failure
  • ASA physical status IV or higher
  • Revision total hip arthroplasty
  • Surgery for pathological fracture or tumor
  • Pregnancy
  • Requirement for general anesthesia
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

Erzincan, Erzincan, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Ayşe Meryem Yalçın, MD

    Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Meryem Yalçın, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The anesthesiologist performing the assigned intervention will not be blinded because of the nature of the procedures. Postoperative outcome assessments will be performed by an investigator blinded to group allocation. The statistical analysis will also be performed without knowledge of group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a 1:1 ratio to receive either an ultrasound-guided PENG block or intrathecal morphine as part of the perioperative analgesic strategy for total hip arthroplasty.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations