NCT05524038

Brief Summary

the purpose of study is comparison between the analgesic effect of two techniques in adult lower abdominal surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 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

Study Start

First participant enrolled

September 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 20, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

August 29, 2022

Last Update Submit

August 15, 2025

Conditions

Keywords

Quadratus LumborumErecto Spinae plane

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    Millie gram

    24 hours after the end of operation

Secondary Outcomes (8)

  • Ease of performance.

    during performance of the block

  • Bowel injury

    24hours after operation

  • intra vascular injection

    24hours after operation

  • Hematoma formation

    24hours after operation

  • Pruritus

    24hours after operation

  • +3 more secondary outcomes

Other Outcomes (10)

  • time of first using of analgesic

    24 hours

  • Visual Analogue Score immediately .

    1 minute post operative

  • Visual Analogue Score at (4)

    4 hour post operative

  • +7 more other outcomes

Study Arms (2)

(QL) group

ACTIVE COMPARATOR

In (QL) group, (lateral Approach) :patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

Drug: Bupivacaine HydrochlorideDevice: Ultrasound deviceDrug: DexamethasoneDevice: echogenic needle

(ESB) group

ACTIVE COMPARATOR

In (ESB) group, Erector Spinae Plane Block: patient receive this block with 20 mg bupivacaine hydrochloride plus 4mg dexamethasone

Drug: Bupivacaine HydrochlorideDevice: Ultrasound deviceDrug: DexamethasoneDevice: echogenic needle

Interventions

20mg of Bupivacaine hydrochloride as local anesthetic will be used in (QL) group and (ESB) group

Also known as: Marcaine 0.25%
(ESB) group(QL) group

high-frequency linear probe covered with sterile sheath Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810, USA) for performing the blocks .

(ESB) group(QL) group

injection of 4mg dexamethasone in each block

Also known as: Dexamethasone 4mg/ml
(ESB) group(QL) group

22- gauge, 50 mm echogenic needle (Stimuplex D; B Braun, Germany) for performing the blocks .

(ESB) group(QL) group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients age 18-60 years old.
  • Patients scheduled for elective abdominal surgeries
  • ASA classification I, II.
  • Ability to sign the consent.

You may not qualify if:

  • Patient refusal.
  • Coagulation disorders.
  • Skin lesions or infection at site of proposed needle.
  • Known allergy to local anesthetics, or opioids.
  • Patients suffering from neurological or mental disease.
  • Opioid consumption 48 hours before the operation.
  • Sever Obesity body mass index(BMI) \>35
  • Difficulty in Ultrasonographic identification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospital

Al Fayyum, Fayoum Governorate, 63514, Egypt

Location

Related Publications (2)

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016BACKGROUND
  • El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available.

    PMID: 28188611BACKGROUND

MeSH Terms

Interventions

BupivacaineUltrasonographyDexamethasone

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • rana A. Abdelghaffar, MD

    faculty of medicine ,Fayum university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Randomization will be done by random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened on the day of surgery when the patient is in the operating room and participant will receive either (QLB) or (ESPB) as per the envelope.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. (QL) QLB group 2. (ESB) group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesiology

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 1, 2022

Study Start

September 1, 2021

Primary Completion

May 1, 2024

Study Completion

February 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations