NCT06017401

Brief Summary

Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started May 2023

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

May 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

August 20, 2023

Last Update Submit

March 4, 2024

Conditions

Postoperative PainSurgery

Keywords

Postoperative painPain managementOblique subcostal transversus abdominis plane blockTransmuscular quadratus lumborum blockQuality of Recovery

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24 hours total analgesic consumption

    The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.

    24 hours postoperatively

Secondary Outcomes (1)

  • The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients

    24 hours postoperatively

Study Arms (2)

Group OSTAP

ACTIVE COMPARATOR

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

Procedure: Oblique Subcostal Transversus Abdominis Plane Block

Group TQLB

ACTIVE COMPARATOR

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Procedure: Transmuscular Quadratus Lumborum Block

Interventions

Oblique Subcostal Transversus Abdominis Plane BlockPROCEDURE

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

Group OSTAP
Transmuscular Quadratus Lumborum BlockPROCEDURE

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

Group TQLB

Eligibility Criteria

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

You may qualify if:

  • Ages of 18-65
  • Patients who will undergo laparoscopic gynecological surgery
  • ASA I-II-III patients
  • Body Mass Index (BMI) in the range of 18-25 kg/m²
  • Patients who will undergo surgery using 3 or 4 trocars

You may not qualify if:

  • ASA IV-V
  • Patients with a known or suspected allergy to local anesthetics
  • Coagulopathy
  • Injection site infection
  • Severe neurological or psychiatric disorders
  • Severe cardiovascular disease
  • Liver failure
  • Kidney failure (glomerular filtration rate \<15 ml/min/m²)
  • Chronic opioid use (\>6 months)
  • Surgical durations less than 45 minutes or greater than 120 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University Faculty of Medicine

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 30, 2023

Study Start

May 22, 2023

Primary Completion

November 27, 2023

Study Completion

February 29, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

TU(1)