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.
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Istanbul
-
Sancaktepe, Istanbul, Turquie (Türkiye), 34000
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative Postoperative Tramadol Consumption
Délai: Postoperative 24 hours
|
Total intravenous tramadol consumption delivered via patient-controlled analgesia during the first 24 hours after surgery.
|
Postoperative 24 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative Pain Scores at Rest
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Postoperative 24 hours
|
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
|
Postoperative 24 hours
|
|
Time to Mobilization
Délai: 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
Délai: 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
Délai: Postoperative 24 hours
|
Incidence of complications related to the regional block procedure, including pneumothorax and local anesthetic systemic toxicity.
|
Postoperative 24 hours
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RIPB-EOIPB-LC-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .