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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272280
• Other study ID #: ABC-5-DE
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: Magdy M mahdy, MD
• Phone: 0109 650 2058
• Email: magdymahdy84[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Assiut, Asyut Governorate, Egypt,

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nalbuphine consumption in mg equivalent to morphine dose.	mg	24 hours postoperatively
Secondary	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
Secondary	Analgesic drug consumption other than nalbuphine	in mg	24 hours postoperatively
Secondary	Heart Rate	beats /min	Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Secondary	Mean Arterial Pressure	mmHg	Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Secondary	Incidence of Postoperative nausea & vomiting (PONV)	Number of patients developing PONV	24 hours postoperatively
Secondary	Shoulder pain	Number of patients developing Shoulder pain	24 hours postoperatively