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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05272280
Other study ID # ABC-5-DE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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