Postoperative Pain, Quality of Recovery
Conditions
Keywords
Quality of recovery, TAP block, Rectus sheath block, OSTAP block, Laparoscopic cholecystectomy
Brief 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. 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.
Interventions
PROCEDURE4-Point TAP (4QTAP) Group
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).
PROCEDURERSB + OSTAP Group
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).
Sponsors
Konya City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery score (QoR-15) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score (VAS) | 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. |
| Incidence of postoperative nausea and vomiting (PONV) | First 24 hours postoperative. | Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale). |
| Antiemetic requirement | First 24 hours postoperative. | Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEsma karaarslan, MD
Outcome results
None listed