Skip to content

Superficial Plane Blocks for Analgesia After Laparoscopic Cholecystectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07834086
Enrollment
90
Registered
2026-09-22
Start date
2026-03-01
Completion date
2026-09-01
Last updated
2026-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Laparoscopic Cholecystectomy

Keywords

Rectointercostal Plane Block, EXORA Block, Numeric Rating Scale, Tramadol, Patient-Controlled Analgesia

Brief summary

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.

Detailed description

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.

Interventions

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

PROCEDUREExternal Oblique-Rectus Abdominis Plane Block

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

DRUGIntravenous Patient-Controlled Analgesia With Tramadol

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

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity at Rest and With Movement0, 2, 4, 6, 12, and 24 hours after surgeryParticipant-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

MeasureTime frameDescription
Sensory Block Distribution Assessed by Pinprick30 minutes after surgeryIn 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.
Cumulative Tramadol ConsumptionDuring the first 24 hours after surgeryTotal tramadol consumption, measured in milligrams, will be recorded during the first 24 postoperative hours.
Incidence of Postoperative Nausea and VomitingDuring the first 24 hours after surgeryThe number and percentage of participants who experience postoperative nausea and/or vomiting will be recorded.
Incidence of Block-Related ComplicationsDuring the first 24 hours after surgeryAmong participants who receive a plane block, the number and percentage who experience any complication considered related to the block procedure will be recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 23, 2026