Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery

Comparison Between Ultrasound Guided Rhomboid Intercostal Plane Block and Thoracic Erector Spinae Plane Block in Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Trial

The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound; Upper Abdominal Surgery; Rhomboid Intercostal Plane Block; Thoracic Erector Spinae Plane Block
• Intervention / Treatment: Drug: Rhomboid intercostal plane block; Other: Erector spinae plane block; Other: Control group

Detailed Description

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.

The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omima M Eldeeb, Master; Phone Number: 01004584669; Email: omima.eldeeb@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Ayman A Yousef, MD
      • Sub-Investigator: Wail E Messbah, MD
      • Sub-Investigator: Naglaa K Mohamed, MD
      • Contact: Omima M Eldeeb, Master; Phone Number: 01004584669; Email: omima.eldeeb@med.tanta.edu.eg
      • Sub-Investigator: Ghada F El Baradey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 21-65 years.
• Both gender.
• American Society of Anesthesiologists (ASA) classification I-II.
• Presented for elective upper abdominal surgery.

Exclusion Criteria:

• Patients refused to participate.
• Patients with known or suspected allergy to the used medication.
• Patients with preoperative chronic pain.
• Patients with major cardiac, renal, respiratory, or hepatic disease.
• Patients with potential risk of coagulopathy.
• Obese patients with body mass index (BMI) >35.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhomboid intercostal plane block group; The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.	Drug: Rhomboid intercostal plane block; The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.
Experimental: Erector spinae plane block group; The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. ESP block will be performed at the level of T9 bilaterally.	Other: Erector spinae plane block; The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. Erector spinae plane block will be performed at the level of T9 bilaterally.
Experimental: Control group; No block will be performed, and patient will receive general anesthesia (GA) only.	Other: Control group; No block will be performed, and patient will receive general anesthesia (GA) only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates The visual analogue scale (VAS). ≥ 4 with maximum dose 20 mg for 24 hours. The total amount of morphine (mg) given will be recorded for the 3 groups.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	Postoperative pain will be assessed by visual analogue scale (VAS) 30 min from admission to PACU, 2, 4, 6, 12, 18 and 24 h postoperative (0= no pain, 10= sever pain).	24 hours postoperatively
Time to 1st request of rescue analgesia	Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated ) will be recorded.	24 hours postoperatively
Heart rate	Heart rate will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery	Every 15 min till the end of surgery
Mean arterial blood pressure	Mean arterial blood pressure will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery	Every 15 min till the end of surgery
Incidence of side effects	Any undesirable adverse events will be treated and recorded (e.g., bradycardia, hypotension, pneumothorax, hematoma, nerve injury and nausea, vomiting, local anesthetic systemic toxicity (LAST), respiratory depression or any other complication).	24 hours Postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 36264MD87/5/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No