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

NCT04167176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-12-20

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

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.

PROCEDURE

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.

DRUG

Lidocaine 2%

Lidocaine 2% will be included in the injected LA mixture.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2022-09-17
Completion
2022-09-17

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167176 on ClinicalTrials.gov