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Effectiveness of Combined Fascial Plane Blocks for Postoperative Pain in Gynecologic Oncology Surgery

Postoperative Analgesic Efficacy of Combined Fascial Plane Blocks After Gynecologic Oncologic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07312825
Enrollment
94
Registered
2025-12-31
Start date
2024-01-01
Completion date
2025-03-20
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancers, Postoperative Pain Management

Keywords

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

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.

Detailed description

This study is a prospective observational research designed to evaluate the postoperative analgesic effectiveness of different combinations of fascial plane blocks in patients undergoing gynecologic oncology surgery. All blocks (Transversus Abdominis Plane \[TAP\] block, Quadratus Lumborum Block \[QLB\], and Rectus Sheath Block \[RSB\]) were performed as part of routine clinical anesthesia practice according to the attending anesthesiologist's preference. No intervention, randomization, or protocol-directed procedure was applied for research purposes. After data collection, patients were classified into three groups based on the block type they had received in standard care: TAP block only TAP + QLB combination TAP + RSB combination The study prospectively compared postoperative pain scores (VAS), opioid consumption, time to mobilization, bowel function recovery, and length of hospital stay among these groups to determine the most effective analgesic strategy within routine practice. This observational design reflects real-world anesthesia management and does not involve any experimental or interventional component.

Interventions

OTHERGroup 1:The Transversus Abdominis Plane (TAP) block

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.

OTHERGroup 2: TAP Block + Quadratus Lumborum Block (QLB)

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.

OTHERGroup 3: TAP Block + Rectus Sheath Block (RSB)

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.

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total Morphine ConsumptionWithin 24 hours after surgeryTotal 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.

Secondary

MeasureTime frameDescription
Postoperative pain intensity (VAS score)0-24 hours postoperatively; VAS score (0-10)Pain intensity will be evaluated using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain) at 0 min, 15 min, 2 hr, 6 hr, 12 hr, and 24 hr postoperatively.
Incidence of postoperative nausea and vomitingTime Frame: 0-24 hours postoperativelyNumber of patients experiencing postoperative nausea and/or vomiting within the first 24 hours.
Time to first gas or stool passageFrom the end of surgery up to postoperative 72 hoursTime from the end of surgery to the first postoperative bowel movement or passage of gas.
Time to oral intakeFrom the end of surgery up to postoperative 72 hoursTime from the end of surgery to the first postoperative oral feeding
Length of hospital stayFrom surgery to hospital discharge (up to 10 days) Unit of Measure:DaysTotal duration of hospitalization after surgery.
Intensive care unit (ICU) length of stayFrom surgery to hospital discharge (up to 3 days) Unit of Measure: DaysTotal duration of postoperative stay in the intensive care unit.
Time to mobilizationFrom the end of surgery up to postoperative 72 hoursTime from the end of surgery to the first postoperative ambulation.

Other

MeasureTime frameDescription
1.Sedation Level (Ramsey Sedation Score)0-24 hours after surgerySedation level evaluated using the Ramsey Sedation Scale at multiple postoperative time points.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026