- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07312825
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
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 2: TAP + QLB Combination
Patients who received both TAP block and Quadratus Lumborum Block (QLB) as part of standard clinical anesthesia management.
|
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 3: TAP + RSB Combination
Patients who received both TAP block and Rectus Sheath Block (RSB) as part of standard clinical anesthesia management.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Morphine Consumption
Time Frame: Within 24 hours after surgery
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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.
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Within 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity (VAS score)
Time Frame: 0-24 hours postoperatively; VAS score (0-10)
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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.
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0-24 hours postoperatively; VAS score (0-10)
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Incidence of postoperative nausea and vomiting
Time Frame: Time Frame: 0-24 hours postoperatively
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Number of patients experiencing postoperative nausea and/or vomiting within the first 24 hours.
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Time Frame: 0-24 hours postoperatively
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Time to first gas or stool passage
Time Frame: From the end of surgery up to postoperative 72 hours
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Time from the end of surgery to the first postoperative bowel movement or passage of gas.
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From the end of surgery up to postoperative 72 hours
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Time to mobilization
Time Frame: From the end of surgery up to postoperative 72 hours
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Time from the end of surgery to the first postoperative ambulation.
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From the end of surgery up to postoperative 72 hours
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Time to oral intake
Time Frame: From the end of surgery up to postoperative 72 hours
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Time from the end of surgery to the first postoperative oral feeding
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From the end of surgery up to postoperative 72 hours
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Length of hospital stay
Time Frame: From surgery to hospital discharge (up to 10 days) Unit of Measure:Days
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Total duration of hospitalization after surgery.
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From surgery to hospital discharge (up to 10 days) Unit of Measure:Days
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Intensive care unit (ICU) length of stay
Time Frame: From surgery to hospital discharge (up to 3 days) Unit of Measure: Days
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Total duration of postoperative stay in the intensive care unit.
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From surgery to hospital discharge (up to 3 days) Unit of Measure: Days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1.Sedation Level (Ramsey Sedation Score)
Time Frame: 0-24 hours after surgery
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Sedation level evaluated using the Ramsey Sedation Scale at multiple postoperative time points.
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0-24 hours after surgery
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FASIALBLOCKJinekoOnkoAnj
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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