NCT07312825

Brief Summary

The goal of this prospective observational study is to compare the effectiveness of different postoperative analgesic techniques in patients undergoing major abdominal surgery for gynecologic oncology. The main question is whether the combination of TAP block with Quadratus Lumborum Block (QLB) or Rectus Sheath Block (RSB) provides superior pain relief compared to TAP block alone. All blocks were performed as part of routine clinical anesthesia practice according to the attending anesthesiologist's judgment. No randomization, allocation, or study-directed intervention was performed. Patients were classified into three groups based on the block type they received during standard care: Group 1: TAP Block Only Group 2: TAP + QLB Combination Group 3: TAP + RSB Combination Postoperative data, including pain scores (VAS), opioid consumption, sedation level, heart rate, blood pressure, nausea/vomiting, and length of hospital stay, were collected prospectively. The study aims to determine which block combination provides the best postoperative pain control and recovery profile in patients undergoing gynecologic oncology surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

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

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
Last Updated

December 31, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 7, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Fascial Plane Blocks for postoperative Analgesia (TAP Block, QLB, RSB)Gynecologic Oncology SurgeryPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total Morphine Consumption

    Total amount of morphine (mg) administered to the patient within the first 24 hours after surgery for postoperative analgesia. Morphine use will be recorded from patient-controlled analgesia (PCA) device data or medical records.

    Within 24 hours after surgery

Secondary Outcomes (7)

  • Postoperative pain intensity (VAS score)

    0-24 hours postoperatively; VAS score (0-10)

  • Incidence of postoperative nausea and vomiting

    Time Frame: 0-24 hours postoperatively

  • Time to first gas or stool passage

    From the end of surgery up to postoperative 72 hours

  • Time to mobilization

    From the end of surgery up to postoperative 72 hours

  • Time to oral intake

    From the end of surgery up to postoperative 72 hours

  • +2 more secondary outcomes

Other Outcomes (1)

  • 1.Sedation Level (Ramsey Sedation Score)

    0-24 hours after surgery

Study Arms (3)

Group 1: TAP Block Only Group

Patients who received only Transversus Abdominis Plane (TAP) block as part of routine anesthesia practice. No additional regional block was performed.

Other: Group 1:The Transversus Abdominis Plane (TAP) block

Group 2: TAP + QLB Combination

Patients who received both TAP block and Quadratus Lumborum Block (QLB) as part of standard clinical anesthesia management.

Other: Group 2: TAP Block + Quadratus Lumborum Block (QLB)

Group 3: TAP + RSB Combination

Patients who received both TAP block and Rectus Sheath Block (RSB) as part of standard clinical anesthesia management.

Other: Group 3: TAP Block + Rectus Sheath Block (RSB)

Interventions

Patients who received only Transversus Abdominis Plane (TAP) block as part of routine clinical anesthesia practice. No study-assigned intervention or randomization was performed. Data were collected prospectively from standard anesthesia records.

Group 1: TAP Block Only Group

Patients who received TAP block combined with Quadratus Lumborum Block (QLB) during routine anesthesia management. This block combination was chosen by the attending anesthesiologist as part of standard care, not assigned by the study.

Group 2: TAP + QLB Combination

Patients who received TAP block combined with Rectus Sheath Block (RSB) as part of routine anesthesia practice. The block technique was performed according to clinical judgment, not as part of a study intervention.

Group 3: TAP + RSB Combination

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of adult female patients who are undergoing elective major abdominal surgery due to gynecologic cancer (e.g., endometrial cancer, ovarian cancer, debulking surgery). Participants will be aged 18 years and older, and only those with ASA I-IV status who are deemed fit for surgery will be included.

You may qualify if:

  • Age 18 years or older.
  • ASA physical status I-IV.
  • Scheduled for major gynecologic oncology surgery (endometrial cancer, ovarian tumor, or cytoreductive surgery).
  • Undergoing general anesthesia.
  • Planned postoperative abdominal fascial plane block for pain management (TAP, TAP + QLB, or TAP + RSB).
  • Able to provide written informed consent.

You may not qualify if:

  • Refusal to participate or inability to provide informed consent.
  • Emergency surgery.
  • Known allergy or contraindication to local anesthetics.
  • Infection at the block site.
  • Coagulopathy or anticoagulant use that contraindicates regional anesthesia.
  • Pre-existing chronic pain conditions or chronic opioid use.
  • Severe hepatic or renal insufficiency.
  • Cognitive impairment that prevents reliable pain assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;24(1):58. doi: 10.1186/s12871-024-02444-6.

  • Zhu JL, Wang XT, Gong J, Sun HB, Zhao XQ, Gao W. The combination of transversus abdominis plane block and rectus sheath block reduced postoperative pain after splenectomy: a randomized trial. BMC Anesthesiol. 2020 Jan 23;20(1):22. doi: 10.1186/s12871-020-0941-1.

  • Akerman M, Pejcic N, Velickovic I. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne). 2018 Feb 26;5:44. doi: 10.3389/fmed.2018.00044. eCollection 2018.

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Anesthesiology

Study Record Dates

First Submitted

April 7, 2025

First Posted

December 31, 2025

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 20, 2025

Last Updated

December 31, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations