NCT06166602

Brief Summary

Postoperative pain management has an important place in anesthesia practices. In order to ensure patient comfort after the surgery, to start postoperative rehabilitation early, and to prevent the process from causing mood disorders such as anxiety and pathological conditions such as chronic pain syndrome, the pain caused by the operation in the postoperative period must be effectively relieved. Pericapsular nerve group (PENG) block; It is a regional anesthesia technique that targets the anterior capsule of the hip joint and aims to block the joint branches of the accessory obturator nerve and femoral nerve by administering local anesthetic. Although it has been described recently, controlled prospective studies in the literature have shown it to be a safe and effective regional technique for postoperative pain after hip surgery. However, volume studies on this block are limited. Therefore, in this study, we aimed to determine the optimal dose by comparing the effectiveness of PENG block on pain using different local anesthetic volumes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

Study Start

First participant enrolled

June 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 4, 2023

Last Update Submit

January 29, 2026

Conditions

Keywords

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale Score

    Numeric Rating Scale Score (0: No pain, 10: Worst pain imaginable)

    Up to 24 hours

Secondary Outcomes (3)

  • Postoperative Opioid Consumption

    Up to 24 hours

  • Postoperative Nausea and Vomiting

    Up to 24 hours

  • Patient satisfaction

    Up to 24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

PENG block was planned to be applied to group 1 patients with 20 cc of 0.25% bupivacaine.

Drug: PENG block with 0.25% bupivacaine.

Group 2

ACTIVE COMPARATOR

PENG block was planned to be applied to group 2 patients with 10 cc of 0.25% bupivacaine.

Drug: PENG block with 0.25% bupivacaine.

Interventions

Peng block will be applied to the same side as the surgery, using 0.25% bupivacaine at the same concentration in different volumes.

Also known as: Marcain®
Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • Patients with informed consent
  • Patients planned for hip surgery
  • Those between the ages of 18-80
  • ASA (American Society of Anesthesiologists) I-III patients

You may not qualify if:

  • Patients who do not give consent
  • Patients with coagulopathy
  • Patients with a history of local anesthetic drug allergy and toxicity
  • Patients with advanced organ failure
  • Patients with mental retardation
  • Patients with infection at the injection site
  • Pediatric patients and patients over 80 years of age
  • Pregnant patients will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

    PMID: 34196965BACKGROUND
  • Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408.

    PMID: 35330408BACKGROUND
  • Lin DY, Brown B, Morrison C, Fraser NS, Chooi CSL, Cehic MG, McLeod DH, Henningsen MD, Sladojevic N, Kroon HM, Jaarsma RL. The Pericapsular Nerve Group (PENG) block combined with Local Infiltration Analgesia (LIA) compared to placebo and LIA in hip arthroplasty surgery: a multi-center double-blinded randomized-controlled trial. BMC Anesthesiol. 2022 Aug 6;22(1):252. doi: 10.1186/s12871-022-01787-2.

    PMID: 35933328BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The investigator is not masked as different volumes are applied.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

June 20, 2023

Primary Completion

December 20, 2023

Study Completion

December 22, 2023

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations