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

NCT ID: NCT04167176

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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Cholecystectomy ESP block Port Site Infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Erector spinae plane block

ultrasound guided ESP Block after anaesthesia induction

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

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.

Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)

Intervention Type DEVICE

Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.

Bupivacaine 0.5%

Intervention Type DRUG

Bupivacaine 0.5% will be included in the injected LA mixture.

Lidocaine 2%

Intervention Type DRUG

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

Port site infiltration technique

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites

Group Type ACTIVE_COMPARATOR

Port site infiltration

Intervention Type PROCEDURE

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.

Bupivacaine 0.5%

Intervention Type DRUG

Bupivacaine 0.5% will be included in the injected LA mixture.

Lidocaine 2%

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Bupivacaine 0.5%

Bupivacaine 0.5% will be included in the injected LA mixture.

Intervention Type DRUG

Lidocaine 2%

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

Intervention Type DRUG

Other Intervention Names

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ESP block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Magdy Mohammed Mahdy Sayed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ABC-3-DE

Identifier Type: -

Identifier Source: org_study_id