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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block
Port site infiltration
Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
Bupivacaine 0.5%
Lidocaine 2%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Cholecystectomy, ESP block, Port Site Infiltration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Erector spinae plane block

Port site infiltration technique

Arm Description

ultrasound guided ESP Block after anaesthesia induction

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

Outcomes

Primary Outcome Measures

Total postoperative opioid consumption.
Nalbuphine consumption in mg.(equivalent to morphine dose)

Secondary Outcome Measures

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).
•Cumulative postoperative analgesic consumption
Analgesic drug consumption other than nalbuphine in mg.
•Heart Rate (HR)
Heart Rate in beats /min
•Mean Arterial Pressure (MAP)
Mean Arterial Pressure in mmHg
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.

Full Information

First Posted
November 6, 2019
Last Updated
December 19, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04167176
Brief Title
Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
Official Title
Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 17, 2022 (Actual)
Study Completion Date
September 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cholecystectomy, ESP block, Port Site Infiltration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
ultrasound guided ESP Block after anaesthesia induction
Arm Title
Port site infiltration technique
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Other Intervention Name(s)
ESP block
Intervention Description
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
Intervention Name(s)
Port site infiltration
Intervention Description
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
Device
Intervention Name(s)
Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
Intervention Description
Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5%
Intervention Description
Bupivacaine 0.5% will be included in the injected LA mixture.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2%
Intervention Description
Lidocaine 2% will be included in the injected LA mixture.
Primary Outcome Measure Information:
Title
Total postoperative opioid consumption.
Description
Nalbuphine consumption in mg.(equivalent to morphine dose)
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
Description
The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).
Time Frame
at 1, 2,4 , 8, 16 and 24 hours postoperatively.
Title
•Cumulative postoperative analgesic consumption
Description
Analgesic drug consumption other than nalbuphine in mg.
Time Frame
24 hours postoperatively
Title
•Heart Rate (HR)
Description
Heart Rate in beats /min
Time Frame
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Title
•Mean Arterial Pressure (MAP)
Description
Mean Arterial Pressure in mmHg
Time Frame
Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Title
Incidence and severity Postoperative nausea & vomiting (PONV).
Description
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.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

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

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