Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries

Not Applicable

Recruiting

• Conditions: Subcostal Cancer Surgeries; Analgesia; Erector Spinae Plane Block; External Oblique Intercostal Plane Block
• Interventions: Drug: External Oblique Intercostal Plane Block; Drug: Erector Spinae Plane Block

• Registration Number: NCT06519708
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.

Detailed Description

Subcostal incisions in cancer surgeries as in hepatectomy and nephrectomy are a cause of severe pain and can lead to significant respiratory impairment. Regional anesthesia of the trunk and abdominal wall is usually centered on epidural analgesia.

Erector spinae plane block (ESPB) is the deposition of local anesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

The recently described external oblique intercostal plane block (EOIPB) is a simple, effective, and convenient block, particularly in the context of morbid obesity, at which local anesthetic (LA) is deposited in the interfacial plane deep to external oblique muscle at the sixth intercostal space. It provides a blockade of the thoracoabdominal nerves at the level of T6 to T10.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Study Start: 2024-07-25
• Study First Posted: 2024-07-25
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-05-27
• Study Completion: 2025-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age (18-65) Years.
• Both sexes.
• Body mass index (BMI): (20-40) kg/m2.
• American Society of Anesthesiology (ASA) physical status II, III.
• Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.

Exclusion Criteria

• Patient refusal.
• Subcostal incisions that are crossing the midline or midline incision.
• Age <18 years or >65 years
• BMI <20 kg/m2 and >40 kg/m2
• Known sensitivity or contraindication to drugs used in the study
• Contraindication to regional anesthesia e.g. local infection at the site of introduction, pre-existing peripheral neuropathies, and coagulopathy.
• Pregnancy.
• Physical status ASA IV
• patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
• patients with a history of drug abuse
• patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
• All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External Oblique Intercostal Plane Block	External Oblique Intercostal Plane Block	Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.
Erector Spinae Plane Block	Erector Spinae Plane Block	Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Total amount of morphine consumption	24 hours postoperatively	Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Secondary Outcome Measures

Name	Time	Method
Time of first rescue analgesia	24 hours postoperatively	Time of first rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated. Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4.
Mean arterial blood pressure	Till the end of surgery	Mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.
Complications	24 hours postoperatively	Complications related to blocks (local anesthetic systemic toxicity, pneumothorax and arterial puncture) and Morphine related complications (respiratory depression, urine retention or pruritis) will be recorded.
Total amount of intraoperative fentanyl consumption	Intraoperatively	Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Heart rate	Till the end of surgery	Heart rate will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.
Patient satisfaction	24 hours postoperatively	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt