Two Bupivacaine Concentrations for Rectus Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy

NCT07841951 | Not Yet Recruiting

• 1 other identifier: Cholecyst Bupivacaine dose2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after laparoscopic cholecystectomy remains a clinically relevant problem despite the minimally invasive nature of the procedure, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The rectus intercostal fascial plane block (RIFPB) is a recently described interfascial technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the T6-T9 thoracoabdominal nerves. In a previous randomized controlled trial conducted at the investigators' institution, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial, however, used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and its limitations section highlighted the need to determine whether comparable analgesia can be achieved with lower doses. Because the efficacy of fascial plane blocks depends on the spread of local anesthetic, large volumes are preferred, which increases total dose and the risk of local anesthetic systemic toxicity (LAST); reducing concentration as volume increases has therefore been recommended. Equal-volume comparisons in transversus abdominis plane and erector spinae plane blocks suggest that lower local anesthetic concentrations provide comparable analgesia. No study has yet compared different concentrations for RIFPB. The aim of this trial is to compare, at a fixed volume of 30 mL per side (60 mL in total), bilateral RIFPB performed with 0.25% bupivacaine, bilateral RIFPB performed with 0.125% bupivacaine, and routine analgesic management with port-site infiltration (control), in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio. The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes are numeric rating scale (NRS) pain scores at rest and on movement, the proportion of patients requiring rescue analgesia, time to first rescue analgesic, the incidence of nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay. The investigators hypothesize that RIFPB at either concentration will reduce postoperative analgesic consumption and pain scores compared with the control group, and that the lower concentration will provide comparable analgesia while halving the total bupivacaine dose (75 mg instead of 150 mg) and thereby reducing the risk of LAST.

Conditions

Postoperative Pain; Acute Pain; Cholelithiasis; Anesthesia

Keywords

rectus intercostal fascial plane block; RIFPB; fascial plane block; bupivacaine; local anesthetic concentration; postoperative analgesia; laparoscopic cholecystectomy; opioid consumption; regional anesthesia; ultrasound-guided nerve block; local anesthetic systemic toxicity

Outcome Measures

Primary Outcomes (1)

• Total rescue tramadol consumption during the first 24 postoperative hours

  Cumulative dose of intravenous tramadol administered as rescue analgesia (milligrams) during the first 24 hours after extubation. Rescue tramadol 0.5-1 mg/kg intravenously is administered whenever the numeric rating scale (NRS) score is 4 or higher.

  0 to 24 hours after extubation

Secondary Outcomes (9)

• Pain intensity at rest measured with the Numeric Rating Scale (NRS)

  1, 3, 6, 12, 18 and 24 hours after extubation

• Pain intensity on movement measured with the Numeric Rating Scale (NRS)

  1, 3, 6, 12, 18 and 24 hours after extubation

• Proportion of participants requiring rescue analgesia

  0 to 24 hours after extubation

• Time to first rescue analgesic request

  0 to 24 hours after extubation

• Incidence of postoperative nausea and vomiting

  0 to 24 hours after extubation

Study Arms (3)

Group Y - RIFPB with 0.25% bupivacaine

EXPERIMENTAL

Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total). Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.

Drug: Bupivacaine 0.25% - rectus intercostal fascial plane block

Group D - RIFPB with 0.125% bupivacaine

EXPERIMENTAL

Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The injected volume is identical to that of Group Y; only the administered dose differs. Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.

Drug: Bupivacaine 0.125% - rectus intercostal fascial plane block

Group K - Control (port-site infiltration)

ACTIVE COMPARATOR

No fascial plane block is performed. Patients are managed with the institution's routine analgesic protocol, including port-site infiltration with 30 mL of 0.25% bupivacaine performed by the surgical team. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.

Drug: Bupivacaine 0.25% - port-site infiltration

Interventions

Bupivacaine 0.25% - rectus intercostal fascial plane block DRUG

Bilateral ultrasound-guided RIFPB with a high-frequency linear probe (11-12 MHz) and an 80 mm block needle. The probe is placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages; after in-plane hydrodissection with 5 mL of saline, 30 mL of 0.25% bupivacaine is injected on each side (60 mL, 150 mg in total). Aspiration is performed before injection and the drug is given in fractionated doses.

Group Y - RIFPB with 0.25% bupivacaine

Bupivacaine 0.125% - rectus intercostal fascial plane block DRUG

Bilateral ultrasound-guided RIFPB performed with the identical technique and the identical volume as in Group Y, using 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The solution is prepared by diluting 15 mL of 0.5% bupivacaine with 45 mL of 0.9% saline.

Group D - RIFPB with 0.125% bupivacaine

Bupivacaine 0.25% - port-site infiltration DRUG

Routine institutional practice: infiltration of the laparoscopic port sites by the surgical team with 30 mL of 0.25% bupivacaine (75 mg). No fascial plane block is performed.

Group K - Control (port-site infiltration)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Aged between 18 and 65 years
• American Society of Anesthesiologists (ASA) physical status I or II
• Body weight above 60 kg
• Able and willing to provide written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to local anesthetics or opioids
• Coagulopathy or ongoing anticoagulant therapy
• Infection at the site of block injection
• Alcohol or substance dependence, or chronic opioid use
• Pregnancy or lactation
• Advanced hepatic or renal failure
• Any condition preventing the participant from understanding and using the - numeric rating scale
• Refusal to participate

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Mega Hospital Complex, Department of Anesthesiology and Reanimation

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Park YJ, Chu S, Yu E, Joo JD. Comparison of the efficacy of erector spinae plane block according to the difference in bupivacaine concentrations for analgesia after laparoscopic cholecystectomy: a retrospective study. J Yeungnam Med Sci. 2023 Apr;40(2):172-178. doi: 10.12701/jyms.2022.00500. Epub 2022 Sep 23.

  PMID: 36137572 BACKGROUND

• Nonphiaraj S, Siwakul P, Sangsungnern P, Intrapongpan J, Theeragul S, Nuwatkrisin K, Somdee W, Wanphon K. Ultrasound-Guided Transversus Abdominis Plane Block Using 0.125% versus 0.25% Bupivacaine for Postoperative Opioid Consumption in Kidney Transplant Recipients: A Prospective, Randomized, Double-Blind Clinical Trial. J Pain Res. 2026 Feb 21;19:578126. doi: 10.2147/JPR.S578126. eCollection 2026.

  PMID: 41755905 BACKGROUND

• Erdogan Ari D, Yildirim Ar A, Karadogan F, Ozcabi Y, Kocoglu A, Kilic F, Akgun FN. Ultrasound-guided transversus abdominis plane block in patients undergoing open inguinal hernia repair: 0.125% bupivacaine provides similar analgesic effect compared to 0.25% bupivacaine. J Clin Anesth. 2016 Feb;28:41-6. doi: 10.1016/j.jclinane.2015.07.020. Epub 2015 Sep 9.

  PMID: 26363806 BACKGROUND

• Bailey JG, Barry G, Volk T. Local anesthetic dosing for fascial plane blocks to avoid systemic toxicity: a narrative review. Can J Anaesth. 2025 Sep;72(9):1423-1447. doi: 10.1007/s12630-025-03034-x. Epub 2025 Sep 15.

  PMID: 40954415 BACKGROUND

• Danisan HG, Omur B, Ince A, Golboyu BE, Ozdenkaya Y, Yanaral TU, Gezen C, Ciftci B. Efficacy of ultrasound-guided recto-intercostal fascial plane block for postoperative analgesia in laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2026 Jul;40(7):5760-5768. doi: 10.1007/s00464-026-12787-5. Epub 2026 Apr 17.

  PMID: 42301457 BACKGROUND

• 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: 37295124 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Cholelithiasis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Burak Ömür

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Ömür, MD

CONTACT

+905056215056; bomur@medipol.edu.tr

Burak Ömür, MD

CONTACT

+905056215056

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All interventions are performed under general anesthesia, so participants are unaware of their group allocation. Study solutions for the two block groups are prepared by an anesthesiologist not otherwise involved in the trial and supplied in identical, indistinguishable syringes labelled only with the randomization number; because both solutions are clear, the anesthesiologist performing the block is also blinded to the bupivacaine concentration. All postoperative assessments are performed by an anesthesiologist blinded to group allocation who takes no part in the intervention. The operating-room team cannot be blinded to the presence or absence of a block, and therefore cannot be blinded to the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Reanimation

Model Details: Three parallel groups randomly allocated in a 1:1:1 ratio; each participant receives a single allocated intervention at the end of surgery.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): April 5, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 3 years after publication of the main results
• Access Criteria: Requests should be sent by e-mail to the principal investigator and must include a methodologically sound research proposal. Data will be shared after approval of the proposal and completion of a data access agreement.

Locations

TU (1)