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

Not Applicable

Recruiting

• Conditions: Ultrasound; Rhomboid Intercostal Plane Block; Thoracic Erector Spinae Plane Block; Upper Abdominal Surgery
• Interventions: Drug: Rhomboid intercostal plane block; Other: Erector spinae plane block; Other: Control group

• Registration Number: NCT06654635
• Lead Sponsor: Tanta University

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.

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 Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rhomboid intercostal plane block group	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.
Erector spinae plane block group	Erector spinae plane block	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.
Control group	Control group	No block will be performed, and patient will receive general anesthesia (GA) only.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Degree of pain	24 hours postoperatively	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).
Time to 1st request of rescue analgesia	24 hours postoperatively	Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated ) will be recorded.
Heart rate	Every 15 min till the end of surgery	Heart rate will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery
Mean arterial blood pressure	Every 15 min till the end of surgery	Mean arterial blood pressure will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery
Incidence of side effects	24 hours Postoperatively	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).

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt