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Clinical Trials/NCT05930171
NCT05930171CompletedPhase 4

Analgesic Efficacy of Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries

Menoufia University1 site in 1 country24 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Postoperative pain intensity

Study Overview

Brief Summary

The investigators are going to evaluate the postoperative analgesic efficacy of combined LESPB and PENG block after hip surgeries.

Detailed Description

Hip surgeries are very common surgeries and has high postoperative pain potential. There are different ways to execute postoperative analgesia and each of them has advantages and disadvantages. As the patients submitted to this procedure are usually older and with multiple comorbidities, analgesia options with better profile of adverse effects should be preferred. Peripheral nerve block with long-acting local anesthetics is very suitable in this situation, in comparison with systemic or neuraxial opioids.

Pain control after total hip arthroplasty (THA) can be challenging because of complex innervation of the hip joint from both the lumbar and sacral nerve plexus. pain was the cause of 12% of unplanned hospital patient admissions, 60% of these patients were admitted for orthopedic concerns. The consequences of severe postoperative pain are prolonged hospital stay, increase hospital readmission, precipitation in the use of opioids with subsequent increase in postoperative nausea and vomiting, and overall low patient satisfaction. Furthermore, postoperative pain can seriously impact the physical and mental health of the patient and lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ functions.

The hip joint is innervated by the articular branches of multiple nerves that emerge from the lumbosacral plexus (L2-S1). The nerve supply to a specific region of the joint typically corresponds to the innervation of the muscle that crosses it :-

  • The femoral nerve innervates the anterior aspect
  • The obturator nerve supplies the inferior aspect
  • The superior gluteal nerve supplies the superior aspect
  • The nerve to the quadratus femoris innervates the posterior aspect.

Hip joint capsular innervation was found to consistently involve the femoral and obturator nerves, which supply the anterior capsule, and the nerve to the quadratus femoris, which supplies the posterior capsule.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients aged 18-70 years old
  • American Society of Anesthesiologists (ASA) class I to III
  • Scheduled for hip surgery.

Exclusion Criteria

  • Refusal to participate
  • Allergy to any of the study drugs
  • Bleeding disorder
  • Localized infection
  • Neurological disease
  • Renal impairment
  • Psychological disorders
  • Opioid dependent
  • Intellectual disability (patients unable to express pain with visual analogue)
  • Morbid obesity.

Arms & Interventions

Group A: L-ESPB and PENG

Active Comparator

receiving after end of hip surgery (PENG) block first and (LESPB) at lumber 4 vertebrae level

Intervention: Ultrasound guided L-ESPB and PENG block using Bupivacaine (Procedure)

Group B: conventional analgesia

Active Comparator

receiving postoperative conventional analgesia in form of acetaminophen 15 mg/kg/6hrs

Intervention: Postoperative conventional analgesia in form of Acetaminophen (Drug)

Outcomes

Primary Outcomes

Postoperative pain intensity

Time Frame: at 24 hour after the block

Postoperative pain intensity using Visual Analogue Scale (VAS) (which is over 10 centimeter scale) (where 0 indicates no pain at all , 10 indicates severe pain)

Secondary Outcomes

  • Vital signs(assessed at preoperative, postoperative (0,3,6,12,24 hours), Value is averaged of total measurements)
  • Time to first analgesic administration(24 hours postoperative)
  • Patient satisfaction(24 hours after the block)
  • Total Analgesic Requirements(24 hours postoperative)
  • Block failure (patients still feeling pain immediately after 1 hour from block)(1 hour after the block)
  • Adverse events(24 hours after the block)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Walash

Assistant Lecturer of anesthesia, intensive care and pain management

Menoufia University

Study Sites (1)

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