NCT07607262

Brief Summary

This prospective observational study aims to compare the effects of bilateral ultrasound-guided recto-intercostal plane block(RIPB) and bilateral ultrasound-guided external oblique intercostal plane block(EOIPB) on postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Both blocks are performed after anesthesia induction as part of routine preemptive multimodal analgesia practice. Patients who receive bilateral recto-intercostal plane block will be included in the RIPB group, and patients who receive bilateral external oblique intercostal plane block will be included in the EOIPB group. The primary outcome is cumulative intravenous tramadol consumption via patient-controlled analgesia during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores at rest and during activity, rescue analgesic requirement, postoperative nausea and vomiting, time to mobilization, length of hospital stay, quality of recovery assessed using the Quality of Recovery-15 questionnaire, and block-related complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2026

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

April 25, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

May 15, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Recto-intercostal plane blockExternal oblique intercostal plane blockUltrasound-guided fascial plane blockPatient-controlled analgesiaQuality of recoveryNumeric Rating Scale

Outcome Measures

Primary Outcomes (1)

  • Cumulative Postoperative Tramadol Consumption

    Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.

    Postoperative 24 hours

Secondary Outcomes (8)

  • Postoperative Pain Scores at Rest

    Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours

  • Postoperative Pain Scores During Activity

    Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours

  • Quality of Recovery

    Postoperative 24 hours

  • Rescue Analgesic Requirement

    Postoperative 24 hours

  • Postoperative Nausea and Vomiting

    Postoperative 24 hours

  • +3 more secondary outcomes

Study Arms (2)

RIPB Group

Patients who received bilateral ultrasound-guided recto-intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.

Procedure: Bilateral Ultrasound-Guided Recto-Intercostal Plane Block

EOIPB Group

Patients who received bilateral ultrasound-guided external oblique intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.

Procedure: Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block

Interventions

Bilateral external oblique intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the external oblique muscle and the intercostal muscles as part of routine preemptive analgesia.

EOIPB Group

Bilateral recto-intercostal plane block was performed under ultrasound guidance after anesthesia induction. Local anesthetic was injected into the fascial plane between the rectus abdominis muscle and the intercostal structures as part of routine preemptive analgesia.

RIPB Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent will be included.

You may qualify if:

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Written informed consent obtained

You may not qualify if:

  • Refusal to participate
  • Inability to understand the study protocol or provide informed consent
  • Known allergy to local anesthetics, tramadol, paracetamol, dexketoprofen, or other study drugs
  • Chronic opioid or steroid use
  • Psychiatric or cognitive disorder preventing reliable pain assessment
  • Inability to use patient-controlled analgesia
  • Pregnancy or breastfeeding
  • Coagulopathy
  • Infection at the block site
  • Difficult or prolonged intubation requiring three or more attempts
  • Conversion to open surgery
  • Surgery lasting longer than 120 minutes
  • Intraoperative or postoperative complications requiring deviation from the standard analgesia protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Sancaktepe, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

  • Tulgar S, Ahiskalioglu A, Kilicaslan A, Ciftci B, Dost B, Aydin ME, Gurkan Y. Fascial plane blocks as the main anesthetic method: A narrative review. Saudi J Anaesth. 2025 Apr-Jun;19(2):198-208. doi: 10.4103/sja.sja_844_24. Epub 2025 Mar 25.

    PMID: 40255355BACKGROUND
  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PMID: 23411725BACKGROUND
  • 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
  • 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

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 26, 2026

Study Start

April 25, 2026

Primary Completion

June 9, 2026

Study Completion

June 9, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional data privacy policies and participant confidentiality.

Locations