Konya City Hospital
Konya, 420120, Turkey (Türkiye)
NCT Number: NCT07264608
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Konya, 420120, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
-
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 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).
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.
Time frame: 30 minutes, 2 hours, 8 hours, and 24 hours after surgery.
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.
Time frame: First 24 hours postoperative.
Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale).
Time frame: First 24 hours postoperative.
Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1).
Contact information is provided by the study sponsor or research team.
Konya City Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07571902
Neurologic Manifestations, Pain
View Trial DetailsNCT07566819
Benign Gallbladder Disease, Laparoscopic Cholecystectomy
View Trial DetailsNCT07567950
Lung Diseases, Neurologic Manifestations
View Trial DetailsNCT07458360
Arthritis, Joint Diseases
Konya, Turkey (Türkiye)
View Trial Details