NCT05600244

Brief Summary

The aim of this study is to compare between Pericapsular Nerve Group Block, Erector Spinae Plane Block and Quadratus Lumborum Block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

October 26, 2022

Last Update Submit

September 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total amount of rescue analgesia

    Total amount of rescue analgesia in the form of morphine will be recorded

    24 hours postoperatively

Secondary Outcomes (3)

  • First analgesic request

    24 hours Postoperatively

  • Pain level

    48 hours Postoperatively

  • Adverse events

    48 hours Postoperatively

Study Arms (3)

PENG block Technique

EXPERIMENTAL

Patients will receive ultrasound-guided Pericapsular Nerve Group Block using 30 ml bupivacaine 0.25%.

Procedure: PENG block Technique

Lumbar ESPB Technique

EXPERIMENTAL

Patients will receive lumbar erector spinae plane block using 30 ml bupivacaine 0.25%

Procedure: Lumbar ESPB Technique

Transmuscular QLB-t block Technique

EXPERIMENTAL

Patients will receive transmuscular quadratus lumborum block using 30 ml bupivacaine 0.25%

Procedure: Transmuscular QLB-t block Technique

Interventions

A linear probe will be used. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, 30 ml of bupivacaine 0.25% will be injected in the plane beneath the iliopsoas muscle

PENG block Technique

Using the out-plane technique, a 22G/80-mm block needle will be advanced until it reached the transverse process. 0.5-1 ml of the prepared local anesthetic solution, 30 ml bupivacaine 0.25% will be administered leading to hydrodissection to confirm the correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurs when administering local anesthetic . All local anesthetic will be administered to this location between the transverse process and the erector spinae muscle

Lumbar ESPB Technique

A convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest. The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscle, transverse abdominis muscle, internal and externa oblique muscles, and the quadratus lumborum muscle will be identified. A 15 cm 22G insulated needle will be inserted on the posterior corner of the transducer. 30 ml bupivacaine 0.25% will be administered between the quadratus lumborum and psoas muscles into the fascial plane.

Transmuscular QLB-t block Technique

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 years
  • Both genders
  • Body mass index \< 40 kg/m\^2
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Posted for total hip surgeries under spinal anesthesia

You may not qualify if:

  • The presence of contraindications or allergy to local anesthetic agents
  • Chronic use of opioids or corticosteroids
  • Infection at the puncture site
  • Coagulopathy
  • Psychiatric disorders (dementia or cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammad Fouad Algyar

Tanta, ElGharbiaa, 31511, Egypt

RECRUITING

Central Study Contacts

Mohammad F. Algyar, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

First Submitted

October 26, 2022

First Posted

October 31, 2022

Study Start

December 15, 2022

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The data will be available under a reasonable request from the corresponding author.

Shared Documents
STUDY PROTOCOL
Time Frame
One year after the end of the study

Locations