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NCT Number: NCT07332546

EOIB for Pain After Laparoscopic Cholecystectomy

This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves recovery after laparoscopic cholecystectomy, compared with no block.

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Key information

Conditions

Postoperative Pain Laparoscopic Cholecystectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

About this study

Laparoscopic cholecystectomy is a common procedure, yet postoperative pain remains clinically significant despite routine multimodal analgesia, and opioid use may cause adverse effects. External oblique intercostal block (EOIB) is a newer ultrasound-guided fascial plane block that may provide effective analgesia for upper abdominal surgery.

This study is a prospective, randomized, controlled, assessor-blinded trial in patients undergoing elective laparoscopic cholecystectomy. A total of 56 participants will be randomized 1:1 to receive either bilateral ultrasound-guided EOIB or no regional block. EOIB will be performed bilaterally under ultrasound guidance at the level of the 6th rib in the 6th-7th intercostal space using an in-plane technique, with 15 mL of study local anesthetic mixture injected per side. Postoperatively, all participants will receive standardized multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with butorphanol and non-opioid analgesics per protocol.

The primary outcome is total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores (VRS) at prespecified time points, quality of recovery (QoR-15) at 24 hours, opioid consumption from 24-48 hours, postoperative nausea and vomiting, intraoperative hemodynamic events, time to first flatus, and length of hospital stay. The trial aims to determine whether adding bilateral EOIB to standard analgesia can reduce opioid requirements and improve recovery after laparoscopic cholecystectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-85 years, regardless of gender
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Scheduled for elective laparoscopic cholecystectomy
  • Ability to use the intravenous patient-controlled analgesia (IV PCA) system

Exclusion criteria

  • Hepatic disease (e.g., liver enzyme levels ≥ 2× the upper limit of normal)
  • Renal disease (e.g., serum creatinine levels ≥ 2× the upper limit of normal)
  • Allergy or known hypersensitivity to local anesthetics
  • Females who are pregnant or lactating
  • Conversion to open surgery
  • Coagulopathy or current use of anticoagulant medications
  • Opioid use for more than 2 weeks in the past 6 months

Treatment and study plan

External oblique intercostal block (EOIB)

Other

Bilateral ultrasound-guided external oblique intercostal block performed under sterile conditions after induction of general anesthesia and before surgical incision. Using an in-plane technique, the block is performed at the level of the 6th rib in the 6th-7th intercostal space. A local anesthetic mixture is injected with a total volume of 15 mL per side (prepared by mixing 0.75% ropivacaine with normal saline).

Standard care without regional block

Other

Participants do not receive any regional anesthesia/nerve block (including external oblique intercostal block). All participants receive standard general anesthesia and the same standardized postoperative multimodal analgesia regimen as per protocol, including intravenous patient-controlled analgesia (PCA) with butorphanol.

Primary outcomes

  1. Total Butorphanolconsumption in the first 24 hours after surgery

    Time frame: 0-24 hours after surgery

    Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant.

Secondary outcomes

  1. Pain score (VRS) at 24 hours after surgery

    Time frame: 24 hours after surgery

    Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0 = no pain, 10 = worst pain imaginable) at 24 hours after surgery.

  2. Quality of recovery at 24 hours (QoR-15 score)

    Time frame: 24 hours after surgery

    Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15); total score at 24 hours postoperatively.

  3. Butorphanol consumption from 24 to 48 hours after surgery

    Time frame: 24-48 hours after surgery

    Total butorphanol consumption recorded during postoperative hours 24-48 (including PCA-delivered dose and any additional butorphanol administered).

  4. Pain score (VRS) at 48 and 72 hours after surgery

    Time frame: 48 hours and 72 hours after surgery

    Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0-10) at 48 hours and 72 hours after surgery.

  5. Incidence of postoperative nausea and vomiting within 72 hours

    Time frame: 1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)

    Incidence of nausea and/or vomiting recorded during postoperative time intervals (1-6 h, 7-24 h, 25-48 h, and 49-72 h); summarized up to 72 hours.

  6. Incidence of intraoperative hypotension and hypertension

    Time frame: Intraoperative period

    Incidence of intraoperative hypotension and intraoperative hypertension during surgery, recorded per protocol definitions. Blood pressure increase exceeding 30% of the baseline value is used as the measurement criterion.

  7. Time to first flatus

    Time frame: Within 3 days after surgery

    Time from the end of surgery to the first passage of flatus.

  8. Postoperative length of hospital stay

    Time frame: Within 7 days after surgery

    Duration of hospital stay after surgery, measured from the time of surgery to hospital discharge.

Sponsors and collaborators

Lead sponsor

Shiyou Wei

Other

Registry information

Official study title

External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jul 7, 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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