Health TrialsbyHealthPanel

External Oblique Intercostal Block (EOICB) for Laparoscopic Cholecystectomy

ConditionsPostoperative PainLaparoscopic CholecystectomyParavertebral BlockExternal Oblique Intercostal Plane BlockPatient Controlled Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCukurova University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paravertebral Block (PVB)

    Procedure/Surgery

    Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).

  • External Oblique Intercostal Block (EOI Block)

    Procedure/Surgery

    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.

  • Tramadol IV Patient-Controlled Analgesia (PCA)

    Drug

    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.

Treatment groups

147 Participants
are divided into 3 treatment groups
Group A: Paravertebral Block GroupActive comparator 1 intervention
Group B: External Oblique Intercostal Block GroupActive comparator 1 intervention
Group C: Control Group - IV PCA TramadolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour postoperative tramadol consumption

Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.

Time frame
Within the first 24 hours after surgery.

Secondary outcomes

1

Postoperative pain scores at rest

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
1, 6, 12, and 24 hours postoperatively
2

Incidence of postoperative nausea and vomiting

Presence of nausea and/or vomiting requiring antiemetic treatment.

Time frame
Within 24 hours postoperatively
3

Incidence of block-related complications

Presence of complications related to the regional block (e.g., vascular puncture, pneumothorax, local anesthetic systemic toxicity).

Time frame
Intraoperative and first 24 hours after block
4

Patient satisfaction with analgesia

Patient-reported satisfaction score for pain management (0 = very dissatisfied, 10 = very satisfied).

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cukurova University

Lead sponsor

Source ClinicalTrials.gov
Apply now