NCT06402006

Brief Summary

The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks. Group B: Patients will receive Erector spinae plane block. After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure. For (Group A) PENG block will be done before spinal anesthesia. LFCN block will be performed. For (Group B), ESP block will be done before spinal anesthesia. Spinal anesthesia will be chosen as the main anesthetic technique. In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.

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 May 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

April 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

April 28, 2024

Last Update Submit

May 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

    The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

    48 hours

  • presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.

    presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.

    48 hours

  • analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).

    analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).

    48 hours

Study Arms (2)

Combined hip joint PENG block and LFCN block

EXPERIMENTAL

Combined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block

Procedure: PENG blockProcedure: LFCN block

ESP block

EXPERIMENTAL

Erector spinae plane block(ESP)

Procedure: ESP block

Interventions

PENG blockPROCEDURE

pericapsular nerve group block

Combined hip joint PENG block and LFCN block
LFCN blockPROCEDURE

Lateral femoral cutaneous nerve block

Combined hip joint PENG block and LFCN block
ESP blockPROCEDURE

Erector spinae plane block

ESP block

Eligibility Criteria

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

You may qualify if:

  • Patients American Society of anesthesiologists' physical status (ASA) I to III.
  • Aged 18 to 65 years.
  • Both sexes.
  • Patients scheduled for total hip arthroplasty.

You may not qualify if:

  • Patient refusal
  • ASA physical status III or more.
  • Patients with known allergy to any of the study drugs.
  • Infection at the site of injection.
  • Patients with history of cardiovascular disease.
  • Patients with renal disease.
  • Patients with hepatic disease.
  • Patients with neuromuscular disease.
  • Presence of any coagulopathy.
  • Chronic opioid, gabapentin or pregabalin use.
  • Patients with history of any psychiatric disorder.
  • BMI more than 35 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 7, 2024

Study Start

May 15, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

May 4, 2025

Record last verified: 2025-05

Locations