NCT07788911

Brief Summary

This prospective observational cohort study compared postoperative pain outcomes in patients undergoing laparoscopic cholecystectomy who received bilateral external oblique intercostal plane block (EOIPB) alone or bilateral EOIPB combined with bilateral rectus sheath block (RSB). The block technique was selected by the attending anesthesiologist as part of routine clinical practice and was not assigned by the researchers. Postoperative pain intensity was assessed using a 0-10 visual analog scale at 1, 2, 4, 8, 12, and 24 hours after surgery. Intraoperative remifentanil consumption, postoperative rescue analgesic consumption, hemodynamic measurements, postoperative nausea and vomiting, other analgesic-related adverse effects, and patient satisfaction were also evaluated during the first 24 postoperative hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

Laparoscopic CholecystectomyExternal Oblique Intercostal Plane BlockRectus Sheath BlockRegional AnesthesiaPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity Assessed by Visual Analog Scale

    Postoperative pain intensity was assessed using a 0-10 visual analog scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores were compared between the two cohorts.

    At 1, 2, 4, 8, 12, and 24 hours after surgery

Secondary Outcomes (3)

  • Total Intraoperative Remifentanil Consumption

    From induction of anesthesia to the end of surgery

  • Total Postoperative Opioid Consumption

    During the first 24 hours after surgery

  • Patient Satisfaction With Postoperative Analgesia

    At 24 hours after surgery

Study Arms (2)

Bilateral EOIPB Cohort

Participants who received bilateral external oblique intercostal plane block as part of routine clinical care. The block technique was selected and performed by the attending anesthesiologist independently of the study investigators. No rectus sheath block was performed in this cohort.

Procedure: Bilateral External Oblique Intercostal Plane Block

Bilateral EOIPB Combined With Bilateral RSB Cohort

Participants who received bilateral external oblique intercostal plane block combined with bilateral rectus sheath block as part of routine clinical care. Both block procedures were selected and performed by the attending anesthesiologist independently of the study investigators.

Procedure: Bilateral External Oblique Intercostal Plane BlockProcedure: Bilateral Rectus Sheath Block

Interventions

Under ultrasound guidance, bilateral external oblique intercostal plane block was performed using a total of 40 mL of 0.25% bupivacaine solution, with 20 mL administered on each side. The final solution was prepared by mixing 20 mL of 0.5% bupivacaine with 20 mL of normal saline, corresponding to a total bupivacaine dose of 100 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators.

Also known as: EOIPB
Bilateral EOIPB CohortBilateral EOIPB Combined With Bilateral RSB Cohort

Under ultrasound guidance, bilateral rectus sheath block was performed using a total of 20 mL of 0.25% bupivacaine solution, with 10 mL administered on each side. The final solution was prepared by mixing 10 mL of 0.5% bupivacaine with 10 mL of normal saline, corresponding to a total bupivacaine dose of 50 mg. The procedure was selected and performed by the attending anesthesiologist as part of routine clinical practice, independently of the study investigators.

Also known as: RSB
Bilateral EOIPB Combined With Bilateral RSB Cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 to 70 years with American Society of Anesthesiologists physical status I to III who underwent laparoscopic cholecystectomy were included. Participants were observed in two cohorts according to the regional block technique selected and performed by the attending anesthesiologist as part of routine clinical care.

You may qualify if:

  • Adults aged 18 to 70 years
  • American Society of Anesthesiologists physical status I to III
  • Scheduled to undergo laparoscopic cholecystectomy
  • Received bilateral EOIPB alone or bilateral EOIPB combined with bilateral RSB as part of routine clinical care
  • Provided written informed consent to participate

You may not qualify if:

  • Contraindication to regional block procedures, including coagulopathy, anticoagulant use, or local infection at the needle insertion site
  • Known severe cardiovascular, renal, or hepatic disease
  • Life-threatening hematological disease
  • Neurological disease or psychiatric disorder
  • Known allergy to the medications used in the study or to amide-type local anesthetics
  • History of chronic pain
  • History of narcotic substance or alcohol dependence
  • Body mass index of 35 kg/m² or greater
  • Pregnancy
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (3)

  • Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.

    PMID: 30635518BACKGROUND
  • Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.

    PMID: 34626112BACKGROUND
  • Kitamura N, Iida H, Maehira H, Mori H, Sada Y, Shimizu T, Kitagawa H, Tani M. Postoperative analgesic effect of ultrasound-guided rectus sheath block and local anesthetic infiltration after laparoscopic cholecystectomy: Results of a prospective randomized controlled trial. Asian J Endosc Surg. 2022 Jan;15(1):29-35. doi: 10.1111/ases.12957. Epub 2021 Jun 22.

    PMID: 34159732BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

May 15, 2025

Primary Completion

April 26, 2026

Study Completion

April 26, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because an IPD-sharing plan was not included in the approved study protocol or informed consent documents.

Locations