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

NCT05272280 | Recruiting DMC

• 1 other identifier: ABC-5-DE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Cholecystectomy; EOI block; ESP block

Outcome Measures

Primary Outcomes (1)

• Nalbuphine consumption in mg equivalent to morphine dose.

  mg

  24 hours postoperatively

Secondary Outcomes (6)

• Numerical Rating Scale (NRS) at rest and when coughing

  at 1, 2,4 , 8, 16 and 24 hours postoperatively

• Analgesic drug consumption other than nalbuphine

  24 hours postoperatively

• Heart Rate

  Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

• Mean Arterial Pressure

  Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

• Incidence of Postoperative nausea & vomiting (PONV)

  24 hours postoperatively

Study Arms (2)

External oblique intercostal (EOI) block

ACTIVE COMPARATOR

Other: External oblique intercostal (EOI) block

Erector spinae plane block (ESPB)

ACTIVE COMPARATOR

Other: Erector spinae plane block (ESPB)

Interventions

External oblique intercostal (EOI) block OTHER

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.

External oblique intercostal (EOI) block

Erector spinae plane block (ESPB) OTHER

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.

Erector spinae plane block (ESPB)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Assiut, Asyut Governorate, Egypt,, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Magdy M mahdy, MD

CONTACT

0109 650 2058; magdymahdy84@yahoo.com

Amr M.A. Thabet, MD

CONTACT

01068924262; Amrthabet@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: triple
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: May 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Locations

EG (1)