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RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy (RIPB-EOIPB)

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

170

Kontakter och platser

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Studieorter

    • Istanbul
      • Sancaktepe, Istanbul, Turkiet (Türkiye), 34000
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
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.
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.
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cumulative Postoperative Tramadol Consumption
Tidsram: Postoperative 24 hours
Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.
Postoperative 24 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Pain Scores at Rest
Tidsram: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity at rest assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Postoperative Pain Scores During Activity
Tidsram: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Pain intensity during activity assessed using the Numeric Rating Scale, ranging from 0 indicating no pain to 10 indicating the worst imaginable pain.
Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours
Quality of Recovery
Tidsram: Postoperative 24 hours
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.
Postoperative 24 hours
Rescue Analgesic Requirement
Tidsram: Postoperative 24 hours
Number of patients requiring additional rescue analgesia due to Numeric Rating Scale score of 4 or higher.
Postoperative 24 hours
Postoperative Nausea and Vomiting
Tidsram: Postoperative 24 hours
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
Postoperative 24 hours
Time to Mobilization
Tidsram: From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Time from the end of surgery to first postoperative mobilization.
From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.
Length of Hospital Stay
Tidsram: From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Duration of postoperative hospital stay until discharge.
From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.
Block-Related Complications
Tidsram: Postoperative 24 hours
Incidence of complications related to the regional block procedure, including pneumothorax and local anesthetic systemic toxicity.
Postoperative 24 hours

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Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2026

Primärt slutförande (Faktisk)

31 augusti 2026

Avslutad studie (Faktisk)

31 augusti 2026

Studieregistreringsdatum

Först inskickad

15 maj 2026

Först inskickad som uppfyllde QC-kriterierna

20 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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IPD-planbeskrivning

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

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