Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair

NCT06820216 | Completed

• 1 other identifier: 36264PR1064/1/25
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the perioperative analgesic and intraoperative hemodynamic effects of ultrasound-guided bilateral recto-intercostal fascial plane block in patients undergoing laparoscopic Hiatus hernia repair.

Conditions

Rectointercostal; Laparoscopic; Hiatus Hernia

Keywords

Ultrasound; Rectointercostal; Laparoscopic; Hiatus; Hernia

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption in the first 24 hours after surgery.

  opioid dose (morphine 0.05 mg/kg) will be given to patients with pain score ≥ 4.

  24 hours after surgery.

Secondary Outcomes (5)

• Intraoperative fentanyl consumption.

  End of surgery.

• Postoperative pain scores at post-anesthesia care unit arrival, 4 h, 8 h, 12 h, and 24 hour after surgery.

  24 hours after surgery.

• Time to first postoperative opioid analgesic request.

  24 hours after surgery.

• Side effects like postoperative nausea and vomiting, dysphagia and gas bloating after surgery

  24 hours after surgery.

• Degree of patient satisfaction

  24 hour after surgery.

Study Arms (2)

Rectointercostal facial plane block group

EXPERIMENTAL

Patients will receive ultrasound-guided bilateral recto-intercostal facial plane block after induction of general anesthesia.

Drug: Rectointercostal facial plane block using bupivacaine 0.25%

Control group

OTHER

Patients will receive general anesthesia without any block.

Other: No Intervention as a control

Interventions

Rectointercostal facial plane block using bupivacaine 0.25% DRUG

Ultrasound guided bilateral recto-intercostal facial plane block will be done after induction of general anesthesia using bupivacaine 0.25%. A linear ultrasound transducer Philips CX50 (5-14 MHz) will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area. The rectus abdominis muscle and its insertion, 6th and 7th cartilage ribs will be visualized. The needle will be inserted between rectus abdominis muscle and the costal cartilages with an in-plane technique in a caudal-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 20 ml of 0.25% bupivacaine will be injected, the same procedure will be then repeated with 20 ml 0.25% bupivacaine on the contra-lateral side (a total of 40 ml bilaterally).

Rectointercostal facial plane block group

No Intervention as a control OTHER

General anesthesia without performing any block.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years.
• American Society of Anesthesiology (ASA) physical status I-II.
• Both sexes.
• Type 1 hiatus hernia (sliding hiatus hernia) with gastro-esophageal reflux disease and scheduled for elective laparoscopic hiatus hernia repair under general anesthesia.

You may not qualify if:

• Patients with cardiovascular, pulmonary, or neurological diseases.
• History of chronic pain or Long-term or recent use of opioids.
• Coagulation disorders or infection at the block application area.
• History of allergy to local anesthetic drugs.
• History of previous abdominal surgery.
• Pregnancy.
• Patients with gastro-esophageal reflux disease complicated by high grade esophagitis, esophageal stenosis or bleeding, and aspiration pneumonia or asthma.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location

Related Publications (1)

• Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The Analgesic Effects of Ultrasound-guided Recto-intercostal Fascial Plane Block in Laparoscopic Hiatus Hernia Repair: A Randomized Double-Blind Controlled Study. Anaesth Crit Care Pain Med. 2025 Dec 3:101724. doi: 10.1016/j.accpm.2025.101724. Online ahead of print.

  PMID: 41349840 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal; Hernia

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 17, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 21, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: The data will be available upon reasonable request from the corresponding author.

Locations

EG (1)