Nerve block versus IV pain control after laparoscopic gallbladder removal
Paravertebral Block or External Oblique Intercostal Block? A Comparative Analysis of Pain and Opioid Consumption After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This trial will test whether two ultrasound-guided nerve blocks (paravertebral and external oblique intercostal) cut pain and tramadol use compared with IV patient-controlled tramadol in adults having elective laparoscopic gallbladder removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cukurova University Academic / other |
| Locations | 1 site (Adana) |
| Trial ID | NCT07241949 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective, randomized, parallel-group trial will allocate adult patients undergoing elective laparoscopic cholecystectomy to bilateral thoracic paravertebral block, bilateral external oblique intercostal block, or standard systemic analgesia with IV patient-controlled tramadol. All regional blocks are performed under ultrasound guidance after induction of general anesthesia using standardized volumes and concentrations of a long-acting local anesthetic. The primary endpoint is total tramadol consumption within 24 hours after surgery, and secondary outcomes include pain scores, additional analgesic requirements, incidence of nausea/vomiting, time to mobilization, and length of hospital stay. The design tests whether truncal regional techniques provide opioid-sparing analgesia and faster recovery compared with systemic opioid-based regimens.
Who should consider this trial
Good fit: Adults aged 18–65 with ASA physical status I–III scheduled for elective laparoscopic cholecystectomy who can give informed consent and are not chronic opioid users are ideal candidates.
Not a fit: Patients with contraindications to regional blocks (coagulopathy, local infection, allergy), severe hepatic or renal impairment, chronic opioid dependence, BMI >35, pregnancy or breastfeeding, or those who require conversion to open surgery are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, targeted nerve blocks could reduce opioid use and pain after surgery, allowing earlier mobilization and fewer opioid-related side effects.
How similar studies have performed: Paravertebral and other thoracoabdominal fascial plane blocks have demonstrated opioid-sparing and pain-reducing effects in abdominal and thoracic surgery, while the external oblique intercostal block is less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years * Scheduled for elective laparoscopic cholecystectomy under general anesthesia * ASA physical status I-III * Able to understand the study procedure and provide informed consent Exclusion Criteria: Patient refusal or inability to provide informed consent Allergy or contraindication to local anesthetics, tramadol, or study medications Coagulopathy or current anticoagulant therapy Local infection at the planned block injection site Severe hepatic or renal impairment Chronic opioid use or opioid dependence Neurological or psychiatric disorders affecting pain perception or communication Pregnancy or breastfeeding Body mass index (BMI) \> 35 kg/m² Conversion to open cholecystectomy during surgery
Where this trial is running
Adana
- Cukurova University Faculty of Medicine — Adana, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Nurefsan Sadikoglu, MD — Cukurova University Hospital
- Study coordinator: Nurefsan Sadikoglu, MD
- Email: nurefsansadikoglu@gmail.com
- Phone: +(90) 538 926 2414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.