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NCT Number: NCT06654635

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

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ayman A Yousef, MD

SUB_INVESTIGATOR

Ghada F El Baradey, MD

SUB_INVESTIGATOR

Naglaa K Mohamed, MD

SUB_INVESTIGATOR

Omima M Eldeeb, Master

CONTACT

[email protected]

01004584669

Wail E Messbah, MD

SUB_INVESTIGATOR

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Control Group

Other

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

Primary outcomes

  1. Total morphine consumption

    Time frame: 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 outcomes

  1. Degree of pain

    Time frame: 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).

  2. Time to 1st request of rescue analgesia

    Time frame: 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.

  3. Heart rate

    Time frame: 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

  4. Mean arterial blood pressure

    Time frame: 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

  5. Incidence of side effects

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Omima M Eldeeb, Master

CONTACT

[email protected]

01004584669

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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