NCT06828497

Brief Summary

The current investigation aimed to assess the postoperative analgesic efficacy of quadratus lumborum block against erector spinae plane block in sleeve gastrectomy surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 27, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 11, 2025

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • the initial request for analgesia post-surgery

    analgesia request willbe assessed by Pain intensity was measured using the Visual Analogue Scale (VAS) score, the scale from 0 to 10 and 10 is the worst pain

    24 hours

Study Arms (2)

Quadratus lumborum Block Group

ACTIVE COMPARATOR

The patient was in the lateral position, and the US probe was placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe was placed in the midaxillary line, and at this juncture, the layers of abdominal layers started to taper. When the probe was placed in the posterior axillary line as per the posterior approach, sonoanatomy showed first the transversus abdominis disappearing, then the internal oblique and external oblique forming aponeurosis, and the appearance of the QL muscle was noticed. The posterior aspect of the QL muscle was confirmed, and a 22-G block needle was guided, in plane, and the needle tip was inserted into this aspect of the QL muscle. Following aspiration, the local anesthetic was injected into the lift behind the QL muscle. The same procedure was performed bilaterally

Procedure: Technique of erector spinae plane block:

Erector spinae plane block Group

ACTIVE COMPARATOR

The patient will be placed in a sitting position. Under aseptic conditions, a high-frequency linear transducer will be placed on the spinous process at the T8 level on the parasagittal plane and then slide 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle. Using the in-plane technique, the needle was advanced between the transverse process and erector spinae muscle. The correct location was confirmed, and local anesthetic was injected between the muscle and transverse process. The same procedure was performed bilaterally

Procedure: Technique of posterior quadratus lumborum block (QL 2 block):

Interventions

The patient was in the lateral position, and the US probe was placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe was placed in the midaxillary line, and at this juncture, the layers of abdominal layers started to taper. When the probe was placed in the posterior axillary line as per the posterior approach, sonoanatomy showed first the transversus abdominis disappearing, then the internal oblique and external oblique forming aponeurosis, and the appearance of the QL muscle was noticed. The posterior aspect of the QL muscle was confirmed, and a 22-G block needle was guided, in plane, and the needle tip was inserted into this aspect of the QL muscle. Following aspiration, the local anesthetic was injected into the lift behind the QL muscle. The same procedure was performed bilaterally

Erector spinae plane block Group

The patient will be placed in a sitting position. Under aseptic conditions, a high-frequency linear transducer will be placed on the spinous process at the T8 level on the parasagittal plane and then slide 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle. Using the in-plane technique, the needle was advanced between the transverse process and erector spinae muscle. The correct location was confirmed, and local anesthetic was injected between the muscle and transverse process. The same procedure was performed bilaterally

Quadratus lumborum Block Group

Eligibility Criteria

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

You may qualify if:

  • (ASA) I-III,
  • age \> 18 years and less than 60 years
  • both sexes
  • scheduled for laparoscopic sleeve gastrectomy under general anaesthesia

You may not qualify if:

  • patient refusal,
  • bleeding or coagulation abnormality
  • local skin infection and sepsis at site of the block,
  • hypersensitivity to the study drugs,
  • body mass index \> 50 kg/m²,
  • Drug abuse, diabetes mellitus (DM), neurological or neuromuscular diseases, cardiovascular illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptian liver hospital

Al Mansurah, 42526, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and intensive cae

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 14, 2025

Study Start

February 27, 2024

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of the study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations