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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Point TAP (4QTAP) Group | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes, 2 hours, 8 hours, and 24 hours after surgery. |
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Inclusion Criteria:
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
Exclusion Criteria:
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
Morbid obesity (BMI > 35 kg/m²)
Pregnancy or breastfeeding
Cognitive impairment preventing cooperation
Conversion to open cholecystectomy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esma karaarslan, MD | Contact | +905057317061 | esmaayvaz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Esma karaarslan, MD | Konya City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya City Hospital | Konya | Konya | 420120 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| RSB + OSTAP Group | Procedure | 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). |
|
| Incidence of postoperative nausea and vomiting (PONV) | Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale). | First 24 hours postoperative. |
| Antiemetic requirement | Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1). | First 24 hours postoperative. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |