NCT07784192

Brief Summary

Pain after hip replacement surgery is often severe and is commonly treated with opioids, which may cause nausea, vomiting, sedation, difficulty passing urine and slow breathing. This study will compare two ways of controlling pain in adults having hip surgery under spinal anesthesia. One group will receive morphine added to the spinal injection. The other group will receive an ultrasound-guided pericapsular nerve group (PENG) block, in which local anesthetic is injected near the nerves that carry pain signals from the hip joint. Participants will be assigned to one of the two groups by chance. Sixty-four adults aged 18 to 65 years will take part, with 32 in each group. Pain scores at rest and during movement, the total amount of morphine used through a patient-controlled pump, the time until the first request for extra pain medicine, the amount of additional paracetamol used, side effects such as nausea and vomiting, and complications related to the block will be compared between the groups during the first 48 hours after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

August 18, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

August 24, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

25 days

First QC Date

August 18, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

ArthroplastyHip AnalgesiaNerve Block

Outcome Measures

Primary Outcomes (1)

  • Cumulative intravenous morphine consumption at 24 hours

    Total amount of morphine, in milligrams, delivered by the intravenous patient-controlled analgesia device during the first 24 postoperative hours, recorded from the device log. Lower values indicate lower opioid requirement.

    0 to 24 hours after surgery

Secondary Outcomes (7)

  • Cumulative intravenous morphine consumption at 48 hours

    0 to 48 hours after surgery

  • Pain intensity at rest measured with the Visual Analog Scale

    1, 3, 6, 12, 24 and 48 hours after surgery

  • Pain intensity on movement measured with the Visual Analog Scale

    1, 3, 6, 12, 24 and 48 hours after surgery

  • Time to first patient-controlled analgesia demand

    0 to 48 hours after surgery

  • Cumulative paracetamol consumption

    0 to 48 hours after surgery

  • +2 more secondary outcomes

Study Arms (2)

Intrathecal Morphine Group

ACTIVE COMPARATOR

Patients receive spinal anesthesia with 10 mg hyperbaric bupivacaine 0.5% plus 100 micrograms of preservative-free morphine into the intrathecal space.

Drug: MorpineDrug: Bupivacaine

PENG Block Group

EXPERIMENTAL

Patients receive spinal anesthesia with 10 mg hyperbaric bupivacaine 0.5% alone, followed by an ultrasound-guided pericapsular nerve group (PENG) block on the operated side with 20 mL of 0.5% bupivacaine.

Procedure: Ultrasound-guided pericapsular nerve group blockDrug: Bupivacaine

Interventions

Preservative-free morphine hydrochloride 100 micrograms will be added to 10 mg of hyperbaric bupivacaine 0.5% and administered into the intrathecal space at the L3-L4 or L4-L5 interspace as part of spinal anesthesia.

Also known as: Morphine hydrochloride, ntrathecal morphine
Intrathecal Morphine Group

After spinal anesthesia, an ultrasound-guided pericapsular nerve group block will be performed on the operative side. A 21 gauge, 80 to 100 mm echogenic needle will be advanced in-plane from lateral to medial into the fascial plane between the iliopubic eminence and the iliopsoas tendon, and 20 mL of bupivacaine 0.5% will be injected after negative aspiration.

PENG Block Group

Hyperbaric bupivacaine 0.5%, 10 mg, will be administered intrathecally in both groups as the spinal anesthetic. In the PENG block group, an additional 20 mL of bupivacaine 0.5% will be used for the block.

Also known as: Bupivacaine hydrochloride
Intrathecal Morphine GroupPENG Block Group

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 65 years
  • American Society of Anesthesiologists physical status I, II or III
  • Scheduled for unilateral hip surgery under spinal anesthesia, including hip fracture surgery and hip replacement surgery
  • Able to understand and use the Visual Analog Scale and the patient-controlled analgesia device
  • Written informed consent

You may not qualify if:

  • Refusal to participate
  • Known allergy or hypersensitivity to local anesthetics, morphine or paracetamol
  • Any contraindication to spinal anesthesia, including coagulopathy, ongoing anticoagulant therapy, thrombocytopenia, infection at the puncture site, or raised intracranial pressure
  • Local infection or previous surgery at the pericapsular nerve group block site
  • Chronic opioid use or history of substance use disorder
  • Chronic pain requiring regular analgesic treatment before surgery
  • Cognitive impairment, psychiatric disorder or communication difficulty preventing use of the pain scales
  • Pre-existing neurological deficit in the operative lower limb
  • Body mass index above 40 kg/m²
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Hospital

Konya, Selcuklu, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesth Analg. 2007 Sep;105(3):789-808. doi: 10.1213/01.ane.0000278089.16848.1e.

    PMID: 17717242BACKGROUND
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PMID: 30063657BACKGROUND
  • Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

    PMID: 29140962BACKGROUND
  • Pivec R, Issa K, Naziri Q, Kapadia BH, Bonutti PM, Mont MA. Opioid use prior to total hip arthroplasty leads to worse clinical outcomes. Int Orthop. 2014 Jun;38(6):1159-65. doi: 10.1007/s00264-014-2298-x. Epub 2014 Feb 27.

    PMID: 24573819BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosiaHip Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Inci KARA

    Selcuk University Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 25, 2026

Study Start

August 24, 2026

Primary Completion

September 18, 2026

Study Completion

September 25, 2026

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations