NCT07021105

Brief Summary

This study compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

December 6, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

May 21, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

Gynecologic surgeryTransversus abdominis plane blockErector spinae plaen blockQuadratus lumborum blockmorphine consumption

Outcome Measures

Primary Outcomes (1)

  • morphine consumption in the postoperative period

    Thus the primary aim of this study was to assess the morphine consumption in the postoperative period

    For postoperative 24 hours

Secondary Outcomes (1)

  • pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects

    For postoperative 24 hours

Study Arms (4)

Group E

ACTIVE COMPARATOR

Group ESP \& QLB, TAP, Control

Procedure: QLB plane blockProcedure: TAP BlockOther: No intervention

Group Q

ACTIVE COMPARATOR

Group QLB \& ESP, TAP, Control

Procedure: ESP Plane blockProcedure: TAP BlockOther: No intervention

Group T

ACTIVE COMPARATOR

Group T \& ESP, QLB, Control

Procedure: ESP Plane blockProcedure: QLB plane blockOther: No intervention

Group C

NO INTERVENTION

Group C \& ESP, QLB, TAP

Interventions

Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.

Group QGroup T

Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.

Group EGroup T
TAP BlockPROCEDURE

Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.

Group EGroup Q

Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.

Group EGroup QGroup T

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Details80 patients aged between 18 and 69 years, with ASA 1-2 score (mild anemia, hypertension, diabetes, obesity, etc.), who were scheduled to undergo major gynecological abdominal surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 18 and 69 years, with ASA 1-2 score scheduled to undergo major gynecological abdominal surgery

You may not qualify if:

  • ASA score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use Patient-Controlled Analgesia (PCA) device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01330, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Hakkı Ünlügenç, Professör

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group. Group E (n=20): Bilateral erector spinae plane (ESP) block Group Q (n=20): Bilateral quadratus lumborum block (QLB) Group T (n=20): Bilateral transversus abdominis plane (TAP) block Group C (Control group, n=20): No block will be applied
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

May 21, 2025

First Posted

June 13, 2025

Study Start

December 6, 2024

Primary Completion

August 11, 2025

Study Completion

September 10, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations