NCT07676552

Brief Summary

This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 24, 2026

Last Update Submit

June 30, 2026

Conditions

Keywords

Laparoscopic CholecystectomyRectointercostal Plane BlockRICPB

Outcome Measures

Primary Outcomes (1)

  • Cumulative Postoperative Morphine Consumption

    Total morphine consumption administered via patient-controlled analgesia during the first 24 hours after surgery will be recorded.

    Postoperative 24 hours

Secondary Outcomes (3)

  • Postoperative Pain Scores

    Postoperative 1, 3, 6, 12, and 24 hours

  • Rescue Analgesic Requirement

    Postoperative 24 hours

  • Postoperative Complications

    Postoperative 24 hours

Study Arms (2)

RICPB Group

EXPERIMENTAL

Participants will receive an ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) with 30 mL of 0.25% bupivacaine at the end of surgery before emergence from anesthesia.

Procedure: Rectointercostal Plane Block

Port-Site Infiltration Group

ACTIVE COMPARATOR

Participants will receive conventional port-site local anesthetic infiltration at the end of surgery according to the study protocol.

Procedure: Port-Site Local Anesthetic Infiltration

Interventions

Ultrasound-guided unilateral right-sided rectointercostal plane block (RICPB) will be performed at the end of surgery before emergence from anesthesia. A total of 30 mL of 0.25% bupivacaine will be injected into the rectointercostal plane under ultrasound guidance.

Also known as: RICPB
RICPB Group

Conventional port-site local anesthetic infiltration will be performed at the end of surgery according to the study protocol to provide postoperative analgesia.

Port-Site Infiltration Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy
  • Body mass index (BMI) between 18 and 35 kg/m²
  • Ability to understand the study procedures and provide written informed consent

You may not qualify if:

  • Refusal to participate or inability to provide informed consent
  • Known allergy or hypersensitivity to local anesthetics, opioids, or study medications
  • Chronic opioid use or chronic pain syndrome
  • Coagulation disorders or ongoing anticoagulant therapy
  • Infection at the planned injection site
  • Pregnancy or breastfeeding
  • Cognitive impairment or inability to communicate pain scores
  • Severe hepatic, renal, cardiac, or respiratory disease judged by the investigator to interfere with study participation
  • Conversion from laparoscopic to open surgery
  • Previous upper abdominal surgery that may interfere with the block technique or pain assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koç University Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (4)

  • Mendes E, Gokkaya Z, Halis A, Uymaz DS, Gurkan Y. Rectointercostal plane block for postoperative analgesia in preperitoneal enhanced-view totally extraperitoneal umbilical hernia repair: a new indication area. Minerva Anestesiol. 2026 Jan 27. doi: 10.23736/S0375-9393.25.19781-2. Online ahead of print. No abstract available.

    PMID: 41591374BACKGROUND
  • Mendes E, Yaylak D, Sincer Y, Uymaz DS, Gurkan Y. Rectointercostal Fascial Plane Block as a Practical Option for Somatic Analgesia in Gastric Bypass Surgery: A Case Report. A A Pract. 2025 Nov 10;19(11):e02100. doi: 10.1213/XAA.0000000000002100. eCollection 2025 Nov 1.

    PMID: 41212719BACKGROUND
  • Ciftci B, Ahiskalioglu A, Tulgar S. The recto-intercostal fascial plane block: An anatomically grounded solution for upper abdominal analgesia. Indian J Anaesth. 2026 Apr;70(4):601-603. doi: 10.4103/ija.ija_1248_25. Epub 2026 Apr 20. No abstract available.

    PMID: 42145288BACKGROUND
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.

    PMID: 37295124BACKGROUND

MeSH Terms

Conditions

CholelithiasisPain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Ergun Mendes, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be unaware of group allocation. Postoperative assessments, including pain scores, opioid consumption, and postoperative complications, will be performed by an independent outcomes assessor who is blinded to treatment assignment. The anesthesiologist performing the intervention will not be blinded due to the nature of the procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible participants will be randomized in a 1:1 ratio to receive either ultrasound-guided rectointercostal plane block (RICPB) or conventional port-site local anesthetic infiltration following laparoscopic cholecystectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations