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

NCT06654635 | Recruiting

• 1 other identifier: 36264MD87/5/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound; Rhomboid Intercostal Plane Block; Thoracic Erector Spinae Plane Block; Upper Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Degree of pain

  24 hours postoperatively

• Time to 1st request of rescue analgesia

  24 hours postoperatively

• Heart rate

  Every 15 min till the end of surgery

• Mean arterial blood pressure

  Every 15 min till the end of surgery

• Incidence of side effects

  24 hours Postoperatively

Study Arms (3)

Rhomboid intercostal plane block group

EXPERIMENTAL

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

Erector spinae plane block group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

No block will be performed, and patient will receive general anesthesia (GA) only.

Other: Control group

Interventions

Rhomboid intercostal plane block DRUG

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.

Rhomboid intercostal plane block group

Erector spinae plane block OTHER

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.

Erector spinae plane block group

Control group OTHER

No block will be performed, and patient will receive general anesthesia (GA) only.

Control group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Omima M Eldeeb, Master

CONTACT

01004584669; omima.eldeeb@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)