RIPB Versus EOIPB for Pain Control After Laparoscopic Cholecystectomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Bilateral Ultrasound-Guided Recto-Intercostal Plane Block
  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.
• Процедура Bilateral Ultrasound-Guided External Oblique Intercostal Plane Block
  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.

Первичные конечные точки

• Cumulative Postoperative Tramadol Consumption [Срок оценки: Postoperative 24 hours]

Вторичные конечные точки (8)

• Postoperative Pain Scores at Rest [Срок оценки: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours]
• Postoperative Pain Scores During Activity [Срок оценки: Postoperative 20 minutes, 40 minutes, 1, 3, 6, 12, 18, and 24 hours]
• Quality of Recovery [Срок оценки: Postoperative 24 hours]
• Rescue Analgesic Requirement [Срок оценки: Postoperative 24 hours]
• Postoperative Nausea and Vomiting [Срок оценки: Postoperative 24 hours]
• Time to Mobilization [Срок оценки: From the end of surgery until first postoperative mobilization, assessed up to 48 hours postoperatively.]
• Length of Hospital Stay [Срок оценки: From the date of surgery through the date of hospital discharge, assessed up to 30 days postoperatively.]
• Block-Related Complications [Срок оценки: Postoperative 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

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

Публикации

• 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 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. PMID 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. PMID 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. PMID 37295124

Идентификаторы

NCT: NCT07607262 · RIPB-EOIPB-LC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗