Postoperative PainNCT07264608
4-Point TAP Block vs. Combined RSB-OSTAP Block for Recovery After Laparoscopic Cholecystectomy
A study testing 4-Point TAP (4QTAP) Group and RSB + OSTAP Group in people with Postoperative Pain and Quality of Recovery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Quality of Recovery
- What is being tested?
- 4-Point TAP (4QTAP) Group and RSB + OSTAP Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Ability to understand the study and provide written informed consent
Who cannot join
- Allergy or hypersensitivity to local anesthetics or study medications
- Coagulopathy, anticoagulant therapy, or local infection at block site
- Severe pulmonary disease (severe COPD, uncontrolled asthma, respiratory failure)
- NYHA class III-IV heart failure
- History of thoracic or abdominal surgery affecting block area
- Chronic pain syndrome or regular opioid/analgesic use
Show all 11Show fewer
- Morbid obesity (BMI > 35 kg/m²)
- Pregnancy or breastfeeding
- Cognitive impairment preventing cooperation
- Conversion to open cholecystectomy
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Konya City Hospital
Konya, Konya, 420120
Esma karaarslan, MD, Esma, esmaayvaz@gmail.com
About this study
Official title: Comparison of 4-Point Transversus Abdominis Plane Block and Combined Bilateral Rectus Sheath-Oblique Subcostal TAP Block on Quality of Recovery After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management.
In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep.
The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.
- Conditions
- Postoperative Pain, Quality of Recovery
- Being tested
- 4-Point TAP (4QTAP) Group, RSB + OSTAP Group
- Keywords
- Quality of recovery, TAP block, Rectus sheath block, OSTAP block, Laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-Point TAP (4QTAP) GroupProcedure or surgery
4-Point TAP (4QTAP) Group: Ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral injection points. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).
RSB + OSTAP GroupProcedure or surgery
RSB + OSTAP Group:
Ultrasound-guided bilateral rectus sheath block (two injection points) combined with bilateral oblique subcostal TAP block (two injection points) will be performed. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).
| Study group | Role | What they receive |
|---|---|---|
| 4-Point TAP (4QTAP) Group | Experimental | An ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral anatomical sites. A total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point Receives: Procedure: 4-Point TAP (4QTAP) Group |
| RSB + OSTAP Group | Active comparator | A combined bilateral rectus sheath block and bilateral oblique subcostal TAP block will be performed under ultrasound guidance. Four injection points (two RSB + two OSTAP) will be used, and a total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point. Receives: Procedure: RSB + OSTAP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery score (QoR-15)
The Quality of Recovery-15 (QoR-15) questionnaire will be used to assess postoperative recovery quality at 24 hours after surgery.
The QoR-15 scale ranges from 0 to 150 points, with higher scores indicating better recovery quality.
Measured: 24 hours
Secondary outcomes (3)
Postoperative pain score (VAS)
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at predefined time points.
The VAS scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain.
Measured: 30 minutes, 2 hours, 8 hours, and 24 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV)
Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale).
Measured: First 24 hours postoperative.
Antiemetic requirement
Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1).
Measured: First 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Karaarslan, Konya City Hospital
- Investigators
- Esma karaarslan, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264608
- Sponsor's protocol ID
- 4TAB-RSB
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 4-Point Transversus Abdominis Plane Block and Combined Bilateral Rectus Sheath-Oblique Subcostal TAP Block on Quality of Recovery After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264608
- Acronym / sponsor ID
- 4TAB-RSB
- Conditions
- Postoperative Pain, Quality of Recovery
- Keywords
- Quality of recovery, TAP block, Rectus sheath block, OSTAP block, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 4 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.
Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management.
In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep.
The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Point TAP (4QTAP) Group | Experimental | Procedure: 4-Point TAP (4QTAP) GroupAn ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral anatomical sites. A total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point |
| RSB + OSTAP Group | Active comparator | Procedure: RSB + OSTAP GroupA combined bilateral rectus sheath block and bilateral oblique subcostal TAP block will be performed under ultrasound guidance. Four injection points (two RSB + two OSTAP) will be used, and a total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years
- ASA physical status I-II
- Scheduled for elective laparoscopic cholecystectomy
- Ability to understand the study and provide written informed consent
Key exclusion criteria (11 listed)
- Allergy or hypersensitivity to local anesthetics or study medications
- Coagulopathy, anticoagulant therapy, or local infection at block site
- Severe pulmonary disease (severe COPD, uncontrolled asthma, respiratory failure)
- NYHA class III-IV heart failure
- History of thoracic or abdominal surgery affecting block area
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 |
|---|---|---|
| 4-Point TAP (4QTAP) Group4-Point TAP (4QTAP) Group: Ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral injection points. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point). | Procedure or surgery | 4-Point TAP (4QTAP) Group |
| RSB + OSTAP GroupRSB + OSTAP Group: Ultrasound-guided bilateral rectus sheath block (two injection points) combined with bilateral oblique subcostal TAP block (two injection points) will be performed. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point). | Procedure or surgery | RSB + OSTAP Group |
Primary outcome
Quality of Recovery score (QoR-15)
Time frame: 24 hours
The Quality of Recovery-15 (QoR-15) questionnaire will be used to assess postoperative recovery quality at 24 hours after surgery. The QoR-15 scale ranges from 0 to 150 points, with higher scores indicating better recovery quality.
3 secondary outcomes
Postoperative pain score (VAS)
Time frame: 30 minutes, 2 hours, 8 hours, and 24 hours after surgery.
Incidence of postoperative nausea and vomiting (PONV)
Time frame: First 24 hours postoperative.
Antiemetic requirement
Time frame: First 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Esma karaarslan, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-Point TAP (4QTAP) Group and RSB + OSTAP Group in people with Postoperative Pain and Quality of Recovery, run by Konya City 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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esma karaarslan, MD (+905057317061, esmaayvaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery score (QoR-15) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.