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Completed

NCT Number: NCT07834086

Superficial Plane Blocks for Analgesia After Laparoscopic Cholecystectomy

This prospective, single-center observational study will evaluate postoperative analgesia in adults undergoing elective laparoscopic cholecystectomy. Participants will receive routine anesthetic care selected by the responsible anesthesiologist and will be observed in one of three groups: rectointercostal plane block, external oblique-rectus abdominis plane (EXORA) block, or intravenous patient-controlled analgesia (IV PCA). The study will compare postoperative pain scores and sensory block spread. Pain at rest and with movement will be assessed using the 0-to-10 Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours after surgery. Sensory spread will be assessed by pinprick testing across the T4-T12 dermatomes at 30 minutes after surgery. Additional assessments will include 24-hour tramadol consumption, postoperative nausea and vomiting, and block-related complications.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

About this study

The study will prospectively enroll 90 adults aged 18 to 85 years who are scheduled for elective laparoscopic cholecystectomy at Bursa Yuksek Ihtisas Training and Research Hospital. The choice of postoperative analgesic technique will be made by the responsible anesthesiologist as part of routine clinical care; the investigators will not assign participants to an analgesic technique. Participants will be evaluated according to the routine care they receive: rectointercostal plane block, EXORA block, or intravenous patient-controlled analgesia. Investigators will record demographic and clinical characteristics, operative and anesthetic information, the analgesic technique used, local anesthetic type and volume when applicable, and tramadol use. Pain at rest and during movement will be measured with the Numeric Rating Scale at 0, 2, 4, 6, 12, and 24 hours postoperatively. For participants receiving a plane block, dermatomal sensory spread from T4 through T12 will be assessed by pinprick testing at 30 minutes after surgery. The study will also record cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and block-related complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 85 years
  • Scheduled to undergo elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists physical status I, II, or III
  • Provision of written informed consent

Exclusion criteria

  • Age younger than 18 years or older than 85 years
  • Known allergy to local anesthetics
  • Coagulopathy
  • Presence of infection
  • Pregnancy
  • Cognitive impairment
  • Body mass index greater than 35 kg/m²

Treatment and study plan

Rectointercostal Plane Block

Procedure

Ultrasound-guided rectointercostal plane block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.

External Oblique-Rectus Abdominis Plane Block

Procedure

Ultrasound-guided external oblique-rectus abdominis plane (EXORA) block used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.

Other names: EXORA Block

Intravenous Patient-Controlled Analgesia With Tramadol

Drug

Intravenous patient-controlled analgesia with tramadol used for postoperative analgesia as selected by the responsible anesthesiologist during routine clinical care.

Other names: IV PCA With Tramadol

Primary outcomes

  1. Postoperative Pain Intensity at Rest and With Movement

    Time frame: 0, 2, 4, 6, 12, and 24 hours after surgery

    Participant-reported pain intensity will be measured separately at rest and during movement using an 11-point Numeric Rating Scale ranging from 0 to 10, with higher scores indicating greater pain.

Secondary outcomes

  1. Sensory Block Distribution Assessed by Pinprick

    Time frame: 30 minutes after surgery

    In participants who receive a plane block, sensory block distribution will be assessed by pinprick testing across the T4 through T12 dermatomes. Dermatomes demonstrating reduced pinprick sensation will be recorded.

  2. Cumulative Tramadol Consumption

    Time frame: During the first 24 hours after surgery

    Total tramadol consumption, measured in milligrams, will be recorded during the first 24 postoperative hours.

  3. Incidence of Postoperative Nausea and Vomiting

    Time frame: During the first 24 hours after surgery

    The number and percentage of participants who experience postoperative nausea and/or vomiting will be recorded.

  4. Incidence of Block-Related Complications

    Time frame: During the first 24 hours after surgery

    Among participants who receive a plane block, the number and percentage who experience any complication considered related to the block procedure will be recorded.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Postoperative Analgesic Effectiveness of Superficial Plane Blocks in Laparoscopic Cholecystectomy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 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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