NCT06653894

Brief Summary

This prospective, randomized, single-blinded study compares the postoperative analgesic efficacy of the Pericapsular Nerve Group (PENG) block and Quadratus Lumborum Block (QLB) in hip surgeries under spinal anesthesia. the study focuses on time to first rescue analgesia and total analgesic consumption within the first 48 hours postoperatively in patients over 40 years undergoing elective hip surgery. Ninety patients will be randomized into two groups (PENG or QLB) using a sealed envelope method. The study will assess pain scores, opioid consumption, and side effects, hypothesizing that both blocks provide effective analgesia but seek to identify which offers superior efficacy. Statistical analysis will be performed with SPSS, aiming to contribute valuable insights into analgesic techniques for hip surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 21, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
Last Updated

August 7, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

October 21, 2024

Last Update Submit

August 3, 2025

Conditions

Keywords

PENGQLBPostoperative AnalgesiaHip Surgery

Outcome Measures

Primary Outcomes (1)

  • Total Opioid Consumption

    Total Opioid Consumption

    48 hour

Secondary Outcomes (3)

  • Numerical Rating Scale (NRS) Scores

    48 hour

  • Time to First Rescue Analgesic

    48 hours

  • Adverse Events

    48 hour

Study Arms (2)

QLB Group

ACTIVE COMPARATOR

In the QLB (Quadratus Lumborum Block) group, patients will be placed in the lateral decubitus position, and the block will be performed using ultrasound guidance

Procedure: anterior quadratus lumborum block

PENG Block Group

ACTIVE COMPARATOR

In the PENG (Pericapsular Nerve Group) block group, patients will be positioned supine, and the block will be performed under ultrasound guidance.

Procedure: PENG block with 0.25% bupivacaine.

Interventions

In the PENG group, patients were placed in the supine position. A convex ultrasound probe was positioned under sterile conditions on the operated side, aligned with the iliac bone below the anterior superior iliac spine (ASIS). The anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), iliopsoas muscle, and its tendon were identified. Using an in-plane technique, a 22G 100-mm peripheral block needle was advanced toward the IPE, targeting the space between the iliopsoas muscle tendon and the IPE. Proper placement was confirmed via hydrodissection. Subsequently, 20 mL of 0.25% bupivacaine was administered slowly, with aspiration performed every 5 mL to avoid intravascular injection. The correct spread of the local anesthetic was verified via ultrasound, confirming elevation of the iliopsoas tendon.

PENG Block Group

The quadratus lumborum and psoas major muscles, along with the transverse process of the L4 vertebra, were visualized in the midaxillary line using an in-plane technique. A 22G, 100-mm peripheral block needle (Stimuplex® Ultra; B. Braun Melsungen AG, Melsungen, Germany) was advanced into the subfascial plane between the quadratus lumborum and psoas major muscles, and 1-2 mL of 0.9% saline was injected to confirm correct placement via hydrodissection. Following this, 20 mL of 0.25% bupivacaine (Buvasin® 0.5%, VEM, Tekirdağ, Turkey) was injected incrementally, with aspiration performed every 5 mL. Proper spread of the local anesthetic was confirmed by ultrasound visualization of a hypoechoic distribution between the fascial planes.

QLB Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • "Patients aged over 40 years who are scheduled to undergo hip surgery under spinal anesthesia and classified as ASA 1-3 will be included in the study."

You may not qualify if:

  • Patients who refuse the procedure.
  • Patients who will receive general anesthesia or peripheral nerve blocks such as a combination of femoral and sciatic nerve blocks.
  • A history of allergy to local anesthetic agents.
  • Patients with a diagnosis of neurocognitive disorders such as dementia or Alzheimer's disease under active neurological follow-up.
  • Patients with multiple trauma.
  • Patients with severe hearing or vision impairments.
  • Patients with a local infection at the site of the block application.
  • Patients with a Body Mass Index (BMI) \> 35.
  • Patients with a history of severe neurological, cardiovascular, renal, or hepatic disease will be excluded from the study.
  • Patients who, during the postoperative period, required intensive care unit (ICU) admission for more than one day due to hemodynamic monitoring or sedation, as well as those who developed complications during postoperative follow-up-such as re-operation, postoperative hemorrhage, or the need for advanced cardiopulmonary support-were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (3)

  • Stuart Green M, Ryan Hoffman C, Iqbal U, Olabisi Ives O, Hurd B. Transmuscular Quadratus Lumborum Block Reduces Length of Stay in Patients Receiving Total Hip Arthroplasty. Anesth Pain Med. 2018 Nov 20;8(6):e80233. doi: 10.5812/aapm.80233. eCollection 2018 Dec.

    PMID: 30719411BACKGROUND
  • Farag A, Hendi NI, Diab RA. Does pericapsular nerve group block have limited analgesia at the initial post-operative period? Systematic review and meta-analysis. J Anesth. 2023 Feb;37(1):138-153. doi: 10.1007/s00540-022-03129-5. Epub 2022 Nov 7.

    PMID: 36342537BACKGROUND
  • Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

    PMID: 34873023BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 22, 2024

Study Start

October 25, 2024

Primary Completion

April 1, 2025

Study Completion

April 3, 2025

Last Updated

August 7, 2025

Record last verified: 2025-05

Locations