Postoperative Analgesia in Hip Arthroplasty

August 30, 2025 updated by: Fatih Ugun, Balikesir University

Comparison of the Postoperative Analgesic Effectiveness of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Block (PENG) in Hip Arthroplasty

The goal of this clinical trial is to compare analgesic effectiveness of two blocks in hip arthroplasty. The main question that aim to answer is;

-Which block is more efficient? Researchers will compare suprainguinal fascia iliaca block with perineural nerve group block.

Participants will randomized and one of the blocks will be applied.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain and analgesia in hip surgery is an important issue for early mobilization and length of hospital stay. The patient population is usually elderly. Prolonged hospital stay may cause thromboembolic complications due to delayed mobilization, psychiatric conditions such as delirium, and many undesirable conditions caused by pain such as chronicisation of acute pain. There are neuraxial analgesia, regional analgesia and multimodal analgesia regimens that are used together to prevent postoperative pain and to prevent these undesirable conditions caused by pain. Suprainguinal fascia iliaca block and pericapsular nerve group blocks are two of those. With performing these blocks, we will obtain postoperative analgesia and avoid postoperative complications.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteer patients undergoing hip arthroplasty
  • Voluntary patient to undergo elective operation under regional anaesthesia
  • ASA I-II-III
  • BMI≤35 kg/m²

Exclusion Criteria:

  • Obstacles to the application of regional anaesthesia
  • Local Anaesthetic Allergy
  • Coagulopathy
  • Psychiatric disorders and medication
  • Hematological/Oncological disease
  • Severe organ failure
  • Multiple bone fractures
  • Alcohol/Drug addiction
  • Used analgesic medication up to 12 hours before surgery
  • Infection at the Block Application Site
  • Mental Deficiency
  • Morbidly obese patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suprainguinal fascia iliaca block
The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.
Procedure: suprainguinal fascia iliaca block
The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.
Active Comparator: Pericapsular nerve group block
In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the genicular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.
Procedure: Pericapsular nerve group (PENG) block
In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the genicular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the postoperative analgesic efficacy of SFIB and PENG block
Time Frame: 24 hours
Calculating total morphine consumption over 24 hours in patients by using patient controlled analgesia pump.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesia scores
Time Frame: 24 hours
Detecting postoperative analgesia scores during rest and movement by using Numerical Rating Scale (NRS) scores. The scale ranges from 0 - 10. Zero represents no pain, while 10 represents the worst possible pain.
24 hours
Assessment of nausea and vomiting incidence
Time Frame: 24 hours
The incidence of nausea and vomiting was examined at 1, 3, 6, 12, 18, and 24 hours post-intervention. The data were analyzed across groups using a 4-point categorical scoring system, with the following definitions: No nausea: 0; Mild: 1; Moderate: 2; Severe: 3.
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction levels
Time Frame: 24 hour
An assessment was also conducted to determine the subjects' satisfaction levels using the Quality of Recovery-15T (QoR-15T) survey at 24th hour. This scale provides a score ranging from 0 to150, with a high score indicating a good quality of recovery.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Investigators

  • Principal Investigator: Fatih Ugün, M.D., Balikesir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

May 3, 2025

First Submitted That Met QC Criteria

August 30, 2025

First Posted (Estimated)

September 4, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD throughout the trial will be shared.

IPD Sharing Time Frame

Beginning 1 year after the publication of results

IPD Sharing Access Criteria

All study data and analysis stages will be shared with interested researchers 1 year after the study is published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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