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Laparoscopic CholecystectomyRIPB-EOIPBNCT07607262

RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy

An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bilateral Ultrasound-Guided Recto-Intercostal Plane Block and Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block
Type of treatment
Surgery or procedure
How many people
170 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2026to 31 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

    Sancaktepe, Istanbul, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Recto-Intercostal Plane Block and External Oblique Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy

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.

Read the detailed description

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive abdominal surgical procedures. Although it is associated with less postoperative pain and faster recovery compared with open surgery, postoperative pain may still occur due to trocar insertion, abdominal wall trauma, pneumoperitoneum-related peritoneal irritation, and visceral manipulation. Inadequate analgesia may delay mobilization, increase analgesic consumption, contribute to postoperative nausea and vomiting, and negatively affect postoperative recovery.

Ultrasound-guided fascial plane blocks are increasingly used as part of multimodal analgesia strategies for abdominal surgery. These techniques may reduce postoperative analgesic requirements by targeting the thoracoabdominal nerve branches that supply the abdominal wall. The recto-intercostal plane block and the external oblique intercostal plane block are two ultrasound-guided fascial plane blocks that may provide analgesia for the upper abdominal wall through different anatomical planes.

This study is designed as a prospective observational study in patients scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients will be included according to the regional analgesia technique performed as part of routine clinical practice. Patients receiving bilateral recto-intercostal plane block will form the RIPB group, while patients receiving bilateral external oblique intercostal plane block will form the EOIPB group. Both blocks will be performed after anesthesia induction as part of a preemptive analgesia approach.

All patients will receive standardized general anesthesia and routine postoperative multimodal analgesia. Intravenous tramadol will be administered postoperatively using a patient-controlled analgesia device. Postoperative pain intensity will be evaluated using the Numeric Rating Scale at predetermined time points during the first 24 hours. Total tramadol consumption, rescue analgesic requirement, postoperative nausea and vomiting, quality of recovery, mobilization time, length of hospital stay, and possible block-related complications will be recorded.

The study aims to determine whether recto-intercostal plane block provides superior postoperative analgesia compared with external oblique intercostal plane block in patients undergoing elective laparoscopic cholecystectomy.

Being tested
Bilateral Ultrasound-Guided Recto-Intercostal Plane Block, Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block
Keywords
Recto-intercostal plane block, External oblique intercostal plane block, Ultrasound-guided fascial plane block, Patient-controlled analgesia, Quality of recovery, Numeric Rating Scale
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral Ultrasound-Guided Recto-Intercostal Plane BlockProcedure or surgery

    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.

  • Bilateral Ultrasound-Guided External Oblique Intercostal Plane BlockProcedure or surgery

    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.

Study groups in NCT07607262
Study groupRoleWhat they receive
RIPB GroupPatients who received bilateral ultrasound-guided recto-intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
Receives: Procedure: Bilateral Ultrasound-Guided Recto-Intercostal Plane Block
EOIPB GroupPatients who received bilateral ultrasound-guided external oblique intercostal plane block after anesthesia induction as part of routine preemptive analgesia for elective laparoscopic cholecystectomy.
Receives: Procedure: Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Postoperative Tramadol Consumption

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

    Measured: Postoperative 24 hours

Secondary outcomes (8)
  1. Postoperative Pain Scores at Rest

    Pain intensity at rest assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.

    Measured: Postoperative 1, 3, 6, 9,12, 18, and 24 hours

  2. Postoperative Pain Scores During Activity

    Pain intensity during activity assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.

    Measured: Postoperative 1, 3, 6, 9, 12, 18, and 24 hours

  3. Quality of Recovery

    Quality of recovery assessed using the Quality of Recovery-15 questionnaire.Quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The Quality of Recovery-15 is a 15-item patient-reported outcome measure with a total score ranging from 0 to 150, where higher scores indicate better postoperative recovery.

    Measured: Postoperative 24 hours

  4. Rescue Analgesic Requirement

    Number of patients requiring additional rescue analgesia due to Numeric Rating Scale score of 4 or higher.

    Measured: Postoperative 24 hours

  5. Postoperative Nausea and Vomiting

    Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.

    Measured: Postoperative 24 hours

  6. Length of Hospital Stay

    Duration of postoperative hospital stay until discharge.

    Measured: From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.

  7. Block-Related Complications

    Incidence of complications related to the regional block procedure, including pneumothorax and local anesthetic systemic toxicity.

    Measured: Postoperative 24 hours

  8. Intraoperative remifentanil consumption

    Total dose of remifentanil administered during the intraoperative period for each participant, recorded from the anesthesia record and expressed in micrograms (µg).

    Measured: From induction of anesthesia to the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start15 May 2026
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07607262
Sponsor's protocol ID
RIPB-EOIPB-LC-01
Acronym
RIPB-EOIPB
Status last verified
Sep 2026
First submitted
15 May 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to institutional data privacy policies and participant confidentiality.

Publications

  • 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.

    PubMed 40255355
  • 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.

    PubMed 23411725
  • 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.

    PubMed 34626112
  • 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.

    PubMed 37295124

Questions about this trial

What is this clinical trial studying?

An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Postoperative Tramadol Consumption (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07607262, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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