Postoperative Pain, Laparoscopic Cholecystectomy, Paravertebral Block, External Oblique Intercostal Plane Block, Patient Controlled Analgesia
Conditions
Keywords
Cholecystectomy, Pain, Analgesia, Tramadol, Nerve Block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREParavertebral Block (PVB)
Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).
PROCEDUREExternal Oblique Intercostal Block (EOI Block)
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.
DRUGTramadol IV Patient-Controlled Analgesia (PCA)
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.
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigator assessing postoperative pain scores will be blinded to the intervention group allocation. Patients and anesthesia providers will not be blinded.
Intervention model description
Participants will be randomly assigned to one of three parallel study arms: (1) paravertebral block, (2) external oblique intercostal block, or (3) intravenous patient-controlled analgesia (PCA) with tramadol. Each participant will receive only the intervention assigned to their group, and no crossover between groups will occur. Outcomes will be assessed over the first 24 postoperative hours following laparoscopic cholecystectomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour postoperative tramadol consumption | Within the first 24 hours after surgery. | Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores at rest | 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. |
| Incidence of postoperative nausea and vomiting | Within 24 hours postoperatively | Presence of nausea and/or vomiting requiring antiemetic treatment. |
| Incidence of block-related complications | Intraoperative and first 24 hours after block | Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity). |
| Patient satisfaction with analgesia | 24 hours postoperatively | Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied). |
Countries
Turkey (Türkiye)
Contacts
CONTACTNurefsan Sadikoglu, MD
CONTACTZehra Hatipoglu, MD
PRINCIPAL_INVESTIGATORNurefsan Sadikoglu, MD
Cukurova University Hospital
Outcome results
None listed