Gynecologic CancersNCT07312825
Effectiveness of Combined Fascial Plane Blocks for Postoperative Pain in Gynecologic Oncology Surgery
An observational study of Gynecologic Cancers and Postoperative Pain Management, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers, Postoperative Pain Management
- What is being tested?
- Group 1:The Transversus Abdominis Plane (TAP) block, Group 2: TAP Block + Quadratus Lumborum Block (QLB) and Group 3: TAP Block + Rectus Sheath Block (RSB)
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Gynecologic Cancers, Postoperative Pain Management
- Being tested
- Group 1:The Transversus Abdominis Plane (TAP) block, Group 2: TAP Block + Quadratus Lumborum Block (QLB), Group 3: TAP Block + Rectus Sheath Block (RSB)
- Keywords
- Fascial Plane Blocks for postoperative Analgesia (TAP Block, QLB, RSB), Gynecologic Oncology Surgery, Postoperative Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1:The Transversus Abdominis Plane (TAP) blockOther
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 Block + Quadratus Lumborum Block (QLB)Other
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 Block + Rectus Sheath Block (RSB)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Group 3: TAP Block + Rectus Sheath Block (RSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after surgery
Secondary outcomes (7)
Postoperative pain intensity (VAS score)
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.
Measured: 0-24 hours postoperatively; VAS score (0-10)
Incidence of postoperative nausea and vomiting
Number of patients experiencing postoperative nausea and/or vomiting within the first 24 hours.
Measured: Time Frame: 0-24 hours postoperatively
Time to first gas or stool passage
Time from the end of surgery to the first postoperative bowel movement or passage of gas.
Measured: From the end of surgery up to postoperative 72 hours
Time to mobilization
Time from the end of surgery to the first postoperative ambulation.
Measured: From the end of surgery up to postoperative 72 hours
Time to oral intake
Time from the end of surgery to the first postoperative oral feeding
Measured: From the end of surgery up to postoperative 72 hours
Length of hospital stay
Total duration of hospitalization after surgery.
Measured: From surgery to hospital discharge (up to 10 days) Unit of Measure:Days
Intensive care unit (ICU) length of stay
Total duration of postoperative stay in the intensive care unit.
Measured: From surgery to hospital discharge (up to 3 days) Unit of Measure: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Menekşe Çakır, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312825
- Sponsor's protocol ID
- FASIALBLOCKJinekoOnkoAnj
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 38336613Zhu 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.
PubMed 31973700Akerman 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.
PubMed 29536008
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Combined Fascial Plane Blocks After Gynecologic Oncologic Surgery
- ClinicalTrials.gov ID
- NCT07312825
- Acronym / sponsor ID
- FASIALBLOCKJinekoOnkoAnj
- Conditions
- Gynecologic Cancers, Postoperative Pain Management
- Keywords
- Fascial Plane Blocks for postoperative Analgesia (TAP Block, QLB, RSB), Gynecologic Oncology Surgery, Postoperative Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: TAP Block Only Group | – | Other: Group 1:The Transversus Abdominis Plane (TAP) blockPatients who received only Transversus Abdominis Plane (TAP) block as part of routine anesthesia practice. No additional regional block was performed. |
| Group 2: TAP + QLB Combination | – | Other: Group 2: TAP Block + Quadratus Lumborum Block (QLB)Patients who received both TAP block and Quadratus Lumborum Block (QLB) as part of standard clinical anesthesia management. |
| Group 3: TAP + RSB Combination | – | Other: Group 3: TAP Block + Rectus Sheath Block (RSB)Patients who received both TAP block and Rectus Sheath Block (RSB) as part of standard clinical anesthesia management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1:The Transversus Abdominis Plane (TAP) blockPatients 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. | Other | Group 1: TAP Block Only Group |
| Group 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. | Other | Group 2: TAP + QLB Combination |
| Group 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. | Other | Group 3: TAP + RSB Combination |
Primary outcome
Total Morphine Consumption
Time frame: Within 24 hours after surgery
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.
7 secondary outcomes
Postoperative pain intensity (VAS score)
Time frame: 0-24 hours postoperatively; VAS score (0-10)
Incidence of postoperative nausea and vomiting
Time frame: Time Frame: 0-24 hours postoperatively
Time to first gas or stool passage
Time frame: From the end of surgery up to postoperative 72 hours
Time to mobilization
Time frame: From the end of surgery up to postoperative 72 hours
Time to oral intake
Time frame: From the end of surgery up to postoperative 72 hours
Length of hospital stay
Time frame: From surgery to hospital discharge (up to 10 days) Unit of Measure:Days
Intensive care unit (ICU) length of stay
Time frame: From surgery to hospital discharge (up to 3 days) Unit of Measure: Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Results publication: PubMed 38336613Yu 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.
- Results publication: PubMed 31973700Zhu 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.
- Results publication: PubMed 29536008Akerman 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancers and Postoperative Pain Management, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Consumption (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312825, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.