COMPARISON OF PLAIN BLOCKS FOR POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES

NCT ID: NCT07021105

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-06

Study Completion Date

2025-09-10

Brief Summary

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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.

Detailed Description

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

The primary aim of this study is to assess the morphine consumption in the postoperative period, while secondary aims include pain score, patient satisfaction, the need for rescue analgesia and side effects

Conditions

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Surgery With General Anesthesia Gynecologic Surgical Procedures Plane Block Postoperative Pain Management

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group E

Group ESP \& QLB, TAP, Control

Group Type ACTIVE_COMPARATOR

QLB plane block

Intervention Type PROCEDURE

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.

TAP Block

Intervention Type PROCEDURE

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.

No intervention

Intervention Type OTHER

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

Group Q

Group QLB \& ESP, TAP, Control

Group Type ACTIVE_COMPARATOR

ESP Plane block

Intervention Type PROCEDURE

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.

TAP Block

Intervention Type PROCEDURE

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.

No intervention

Intervention Type OTHER

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

Group T

Group T \& ESP, QLB, Control

Group Type ACTIVE_COMPARATOR

ESP Plane block

Intervention Type PROCEDURE

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.

QLB plane block

Intervention Type PROCEDURE

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.

No intervention

Intervention Type OTHER

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

Group C

Group C \& ESP, QLB, TAP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ESP Plane block

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.

Intervention Type PROCEDURE

QLB plane block

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.

Intervention Type PROCEDURE

TAP Block

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.

Intervention Type PROCEDURE

No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Hakki Unlugenc

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakkı Ünlügenç, Professör

Role: STUDY_DIRECTOR

Cukurova University

Locations

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Cukurova University

Adana, Sarıçam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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Decision No. 145

Identifier Type: -

Identifier Source: org_study_id

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