Recto-intercostal Facial Plane Block in Laparoscopic Hiatus Hernia Repair

NCT ID: NCT06820216

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2025-08-21

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.

Detailed Description

Hiatus hernia is a prevalent condition in which the stomach or other abdominal organs protrude through the esophageal hiatus of the diaphragm into the thoracic cavity due to elevated pressure within the abdomen. Laparoscopic hernioplasty of hiatal hernia has been confirmed effective and safe in recent years and performed more due to its mini-invasive nature and intraperitoneal view and operating angle.

Although patients having laparoscopic hiatus hernia repair experience less pain than open surgery, postoperative pain can still be significant and lead to associated postoperative issues. These issues can include respiratory and other complications, delay in discharge and adverse effects from increasing requirements of systemic analgesia such as opioid. An important consideration in the potential multitude of problems associated with increased opioid use is respiratory depression, sedation, constipation and the propensity for vomiting. Postoperative vomiting can result in the repaired diaphragm enduring excessive pressure and subsequently early recurrence and failure of the procedure.

Recently, a novel block named "recto-intercostal fascial plane block" is performed between the recto abdominal muscle and costal cartilages of ribs 6-7 to block the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators hypothesize that this block may provide perioperative analgesic benefits in patients undergoing Laparoscopic hiatus hernia repair under general anesthesia.

Conditions

Rectointercostal; Laparoscopic; Hiatus Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Rectointercostal facial plane block group

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

Group Type: EXPERIMENTAL

Rectointercostal facial plane block using bupivacaine 0.25%

Intervention Type: 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).

Control group

Patients will receive general anesthesia without any block.

Group Type: OTHER

No Intervention as a control

Intervention Type: OTHER

General anesthesia without performing any block.

Interventions

Rectointercostal facial plane block using bupivacaine 0.25%

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).

Intervention Type: DRUG

No Intervention as a control

General anesthesia without performing any block.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Ahmed Eloraby

lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

36264PR1064/1/25

Identifier Type: -

Identifier Source: org_study_id