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Clinical Trials/NCT06402006
NCT06402006CompletedNot Applicable

A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group (PENG) and Lateral Femoral Nerve Block Following Total Hip Arthroplasty

Ain Shams University1 site in 1 country50 target enrollmentStarted: May 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

Study Overview

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.

Detailed Description

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 PENG and LFCN blocks.

Group B: Patients will receive ESP block, which will be the control group.

After obtaining approval from Ain Shams hospital academic and ethical committee, written, informed and valid consent will be taken from all participants after proper explanation of the study procedure and the expected outcome in a clear language for patients of either sex, aging from 18 to 65 years old, ASA physical status (I, II) scheduled for total hip arthroplasty surgeries.

Patients with the following criteria will be excluded from the study: Patient refusal, ASA physical status III or more, known allergy to any of the study drugs, infection at the site of injection, history of cardiovascular, renal, hepatic or neuromuscular diseases, history of any psychiatric disorder, presence of any coagulopathy, chronic opioid, gabapentin or pregabalin use, BMI more than 35 kg/m2. Patients will be randomly assigned to either both PENG and LFCN blocks and ESP block with ultrasound guidance before spinal anesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

Combined hip joint PENG block and LFCN block

Experimental

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

Intervention: PENG block (Procedure)

Combined hip joint PENG block and LFCN block

Experimental

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

Intervention: LFCN block (Procedure)

ESP block

Experimental

Erector spinae plane block(ESP)

Intervention: ESP block (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: 48 hours

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).

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

Time Frame: 48 hours

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

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

Time Frame: 48 hours

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

riham fathy galal

Lecturer

Ain Shams University

Study Sites (1)

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