NCT06577103

Brief Summary

The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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

January 2, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

August 27, 2024

Last Update Submit

May 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.

    24 hours postoperatively

Secondary Outcomes (4)

  • The ease of giving a sitting position for spinal anesthesia (EOSP)

    Intraoperatively

  • The total dose of nalbuphine consumption

    24 hours postoperatively

  • The number of patients who needed rescue analgesia

    24 hours postoperatively

  • Ablility to walk with support within 24 hours

    24 hours postoperatively

Study Arms (2)

Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)

EXPERIMENTAL

Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.

Other: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)

Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)

EXPERIMENTAL

Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.

Other: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)

Interventions

Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.

Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)

Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.

Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 years.
  • Sex: Both sexes.
  • American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
  • Scheduled for hip hemiarthroplasty under general anesthesia.

You may not qualify if:

  • Declining to give a written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
  • Psychiatric disorders or narcotic abusers.
  • Significant cognitive dysfunction.
  • American Society of Anesthesiologists (ASA) Physical Status Class IV.
  • Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
  • Opioid abuser patients
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11591, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Ain Shams University,Egypt

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 29, 2024

Study Start

January 2, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

May 2, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations