NCT06995404

Brief Summary

Although laparoscopic techniques are considered minimally invasive surgical procedures with lower perioperative pain scores compared to open surgeries, they are still associated with significant levels of pain. This study aims to investigate the analgesic effectiveness of two routinely performed regional analgesic techniques in our clinic-ultrasound-guided classic bilateral TAP block and ultrasound-guided bilateral M-TAPA block-in patients undergoing laparoscopic gyneco-oncologic surgery (LGOS), as well as their effects on intraoperative opioid consumption.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

16 days

First QC Date

April 28, 2025

Last Update Submit

May 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of intraoperative opioid consumption

    during surgery

Secondary Outcomes (1)

  • Comparison of postoperative Visual Analog Scale (VAS) pain scores

    postoperative first day

Study Arms (3)

control

NO INTERVENTION

group TAP

ACTIVE COMPARATOR
Procedure: TAP Block Group

group M-TAPA

ACTIVE COMPARATOR
Procedure: M-TAPA Block group

Interventions

Patients in the TAP group will receive a bilateral Transversus Abdominis Plane (TAP) block under ultrasound guidance prior to surgery after general anaesthesia, with the local anesthetic administered between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.

group TAP

Patients in the M-TAPA group will receive a bilateral Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) under ultrasound guidance prior to surgery after general anaesthesia. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.

group M-TAPA

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Neuropathy
  • Chronic analgesic therapy
  • Severe cardiopulmonary disease
  • Uncontrolled diabetes mellitus (HbA1c \> 8%)
  • Severe renal or hepatic failure
  • Pregnancy or lactation
  • Body mass index (BMI) greater than 35 kg/m²
  • Local infection at the injection site
  • Inability to comprehend pain scores or cooperate (e.g., Alzheimer's disease, mental retardation)
  • Allergy to local anesthetic agents
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Central Study Contacts

ELA ERDEM HIDIROGLU

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 29, 2025

Study Start

May 30, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations