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NCT Number: NCT07149584

Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy

The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

About this study

All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam.

All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cholecystectomy
  • Age >18years
  • American Society of Anesthesiologists classification I-III

Exclusion criteria

  • Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
  • Chronic analgesic use
  • Open cholecystectomy or conversion to open cholecystectomy

Treatment and study plan

ESPB

Procedure

10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.

TPVB

Procedure

10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.

IV

Procedure

Tramadol is administered via intravenous patient-controlled analgesia.

Primary outcomes

  1. Tramadol consumption

    Time frame: postoperative 24 hours

    amount of postoperative 24-hour tramadol consumption

Secondary outcomes

  1. Amount of fentanyl

    Time frame: during surgery

    Amount of fentanyl used intraoperatively

  2. Static and dynamic pain score

    Time frame: postoperative 24 hours

    Static and dynamic pain scores are assessed with numeric rating scale at 0., 1., 4., 6., 12., 18. and 24. hours.

  3. First rescue analgesic time

    Time frame: postoperative 24 hours

    The first time patient required rescue analgesic.

  4. Number of patients required rescue analgesic.

    Time frame: postoperative 24 hours

    If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.

  5. Nausea and vomiting

    Time frame: postoperative 24 hours

    Number of patients experienced postoperative nausea and vomiting

  6. Complications

    Time frame: postoperative 24 hours

    Number of patients experienced complications postoperatively

  7. Quality of recovery

    Time frame: postoperative 24 hours

    Patient recovery quality is evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).

  8. Length of hospital stay

    Time frame: up to 1 week

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy: A Randomized Controlled Trial on Opioid Consumption

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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