Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167176
• Other study ID #: ABC-3-DE
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: September 17, 2022

Study information

• Verified date: December 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 17, 2022
• Est. primary completion date: September 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with the American Society of Anesthesiologists (ASA) physical status I/II,

• Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,

• 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

Procedure:
• Erector spinae plane block
Patients will be placed on their right side. 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 in a cranial to caudal direction. 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 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.
• Port site infiltration
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.

Device:
• Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.

Drug:
• Bupivacaine 0.5%
Bupivacaine 0.5% will be included in the injected LA mixture.
• Lidocaine 2%
Lidocaine 2% will be included in the injected LA mixture.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative opioid consumption.	Nalbuphine consumption in mg.(equivalent to morphine dose)	24 hours postoperatively
Secondary	Pain scores;Numerical Rating Scale (NRS) at rest and when coughing	The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).	at 1, 2,4 , 8, 16 and 24 hours postoperatively.
Secondary	•Cumulative postoperative analgesic consumption	Analgesic drug consumption other than nalbuphine in mg.	24 hours postoperatively
Secondary	•Heart Rate (HR)	Heart Rate in 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 (MAP)	Mean Arterial Pressure in mmHg	Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Secondary	Incidence and severity Postoperative nausea & vomiting (PONV).	Number of patients developing PONV & PONV Score; (1) No nausea or vomiting, (2) only nausea but no vomiting, (3) single episode of vomiting or persistent nausea, and (4) two or more episodes of vomiting or severe retching.	24 hours postoperatively