NCT06488183

Brief Summary

preperitoneal local anesthetic infiltration is effective for relief of postoperative pain in patients undergoing laparoscopic bariatric surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

June 28, 2024

Last Update Submit

January 27, 2025

Conditions

Pain Management

Keywords

preperitoneal infiltration , bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score

    VAS score

    postoperative day 1

Secondary Outcomes (4)

  • postoperative morphine requirements

    postoperative day 1

  • postoperative nausea and vomiting

    postoperative day1

  • length of stay in pacu

    postoperative day 1

  • Length of hospital stay

    postoperative day 3

Study Arms (2)

group p

OTHER

laparoscopic preperitoneal local anesthetic infiltration

Procedure: preperitoneal local anesthetic infiltration in group p , quadratus lamborum block in group Q

group Q

OTHER

ultrasound guided quadratus lamborum block

Procedure: preperitoneal local anesthetic infiltration in group p , quadratus lamborum block in group Q

Interventions

preperitoneal local anesthetic infiltration in group p , quadratus lamborum block in group QPROCEDURE

preperitoneal local anesthetic infiltration in group p quadratus lamborum block in group Q

group Qgroup p

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-50 years, both sexes.
  • ASA physical status class I to III.
  • BMI 35-50 kg/m²

You may not qualify if:

  • Severe cardiac disorder
  • chronic renal failure
  • liver cirrhosis
  • allergy to bupivacaine
  • patients with history of chronic opioid consumption
  • HBA1C \> 7%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

  • Aldohayan A, Alshammari S, Binjaloud A, Bamehriz F, Narejo AS, Aqil M, Aldahian N, Aldabaeab A, Eldawlatly A. Pre-incisional Laparoscopic Preperitoneal Local Anesthetic Technique in Laparoscopic Sleeve Gastrectomy. JSLS. 2022 Jul-Sep;26(3):e2022.00049. doi: 10.4293/JSLS.2022.00049.

    PMID: 36071990BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440sarahelgamal1990@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

May 12, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

EG(1)