Cukurova University Faculty of Medicine
Adana, Turkey (Türkiye)
Location status: Recruiting
Location contact
Nurefsan Sadikoglu, MD
CONTACT
Zehra Hatipoglu, MD
CONTACT
NCT Number: NCT07241949
This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Adana, Turkey (Türkiye)
Location status: Recruiting
Nurefsan Sadikoglu, MD
CONTACT
Zehra Hatipoglu, MD
CONTACT
This single center, prospective, randomised controlled clinical trial is designed to evaluate analgesic efficacy and opioid sparing effect of ultrasound guided paravertebral block (PVB) and external oblique intercostal (EOI) block versus systemic opioid based analgesia in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Pain after laparoscopic cholecystectomy is often moderate to severe during the first 24 hours , and has somatic and visceral components . Regional approaches that target thoracoabdominal dermatomes and visceral afferents may provide superior analgesia, allow for earlier mobilisation, and reduce opioid-related adverse effects compared with intravenous opioid regimens alone. PVB provides unilateral segmental blockade at thoracic paravertebral level, while the EOI block deposits local anaesthetic in the fascial plane between the external oblique and intercostal muscles, with spread to relevant thoracoabdominal nerves.
In a parallel-group design, participants will be randomly allocated to bilateral thoracic PVB, bilateral EOI block or no truncal block with standard systemic analgesia. All regional blocks will be performed under ultrasound guidance after induction of general anaesthesia. Standardised volumes and concentrations of long-acting local anaesthetic will be used according to institutional practice. The control group will receive patient-controlled intravenous opioid analgesia as part of a multimodal approach.
Standardisation of intraoperative monitoring and technique of general anaesthesia according to departmental protocols will be done for perioperative anaesthetic management. Postoperative pain intensity will be assessed by an 11-point Numerical Rating Scale at specified time points during the first 24 hours. Rescue analgesia will be administered according to a predefined algorithm. The trial's purpose is to compare postoperative opioid use between groups and to investigate differences in pain trajectories and opioid-related adverse events in routine clinical conditions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).
Ultrasound-guided bilateral external oblique intercostal block performed after induction of general anesthesia with 0.25% bupivacaine, 20 mL per side (total 40 mL), injected between the external oblique and intercostal muscles.
Intravenous patient-controlled analgesia (PCA) programmed to deliver tramadol with a maximum dose of 400 mg in 24 hours. Standard analgesia protocol includes IV paracetamol 1 g every 8 hours.
Other names: Control group
Time frame: Within the first 24 hours after surgery.
Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.
Time frame: 1, 6, 12, and 24 hours postoperatively
Postoperative pain intensity at rest will be assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate more severe pain.
Time frame: Within 24 hours postoperatively
Presence of nausea and/or vomiting requiring antiemetic treatment.
Time frame: Intraoperative and first 24 hours after block
Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity).
Time frame: 24 hours postoperatively
Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied).
Contact information is provided by the study sponsor or research team.
Nurefsan Sadikoglu, MD
CONTACT
Zehra Hatipoglu, MD
CONTACT
Cukurova University
Other
Paravertebral Block or External Oblique Intercostal Block? A Comparative Analysis of Pain and Opioid Consumption After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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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.
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