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

December 19, 2022 updated by: Magdy Mohammed Mahdy Sayed, Assiut University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Asyut Governorate
      • Assiut, Asyut Governorate, Egypt, 11111
        • Assiut university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae plane block
ultrasound guided ESP Block after anaesthesia induction
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.
Other Names:
  • ESP block
Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
Bupivacaine 0.5% will be included in the injected LA mixture.
Lidocaine 2% will be included in the injected LA mixture.
Active Comparator: 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
Bupivacaine 0.5% will be included in the injected LA mixture.
Lidocaine 2% will be included in the injected LA mixture.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative opioid consumption.
Time Frame: 24 hours postoperatively
Nalbuphine consumption in mg.(equivalent to morphine dose)
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
Time Frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively.
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.
•Cumulative postoperative analgesic consumption
Time Frame: 24 hours postoperatively
Analgesic drug consumption other than nalbuphine in mg.
24 hours postoperatively
•Heart Rate (HR)
Time Frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Heart Rate in beats /min
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
•Mean Arterial Pressure (MAP)
Time Frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Mean Arterial Pressure in mmHg
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence and severity Postoperative nausea & vomiting (PONV).
Time Frame: 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

September 17, 2022

Study Completion (Actual)

September 17, 2022

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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