US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy

Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy

To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: External oblique intercostal (EOI) block; Other: Erector spinae plane block (ESPB)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdy M mahdy, MD; Phone Number: 0109 650 2058; Email: magdymahdy84@yahoo.com
• Study Contact Backup: Name: Amr M.A. Thabet, MD; Phone Number: 01068924262; Email: Amrthabet@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Asyut Governorate, Egypt,
    • Assiut, Assiut, Asyut Governorate, Egypt,, Egypt
      • Recruiting
      • Assiut University Hospital
      • Contact: Magdy M Mahdy, Lecturer; Phone Number: 01096502058; Email: magdy.mahdy@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
• patients with the American Society of Anesthesiologists (ASA) physical status I/II,
• Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

• Allergy to local anaesthetics,
• Infection at the site of injection,
• Coagulopathy,
• Chronic pain syndromes,
• Prolonged opioid medication,
• Patients who received any analgesic 24 h before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: External oblique intercostal (EOI) block	Other: External oblique intercostal (EOI) block; A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Active Comparator: Erector spinae plane block (ESPB)	Other: Erector spinae plane block (ESPB); A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10 cm needle will be inserted using an in plane approach. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of Local Anesthetic mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nalbuphine consumption in mg equivalent to morphine dose.	mg	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative nausea & vomiting (PONV)	Number of patients developing PONV	24 hours postoperatively
Numerical Rating Scale (NRS) at rest and when coughing	11-point scale where 0=no pain and 10=worst pain	at 1, 2,4 , 8, 16 and 24 hours postoperatively
Analgesic drug consumption other than nalbuphine	in mg	24 hours postoperatively
Heart Rate	beats /min	Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Mean Arterial Pressure	mmHg	Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Shoulder pain	Number of patients developing Shoulder pain	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Cholecystectomy; ESP block; EOI block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ABC-5-DE

Drug and device information, study documents

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