- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167176
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
Status
Completed
Conditions
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
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Assiut, Asyut Governorate, Egypt, 11111
- Assiut university Hospital
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-
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:
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)
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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.
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The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).
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at 1, 2,4 , 8, 16 and 24 hours postoperatively.
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•Cumulative postoperative analgesic consumption
Time Frame: 24 hours postoperatively
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Analgesic drug consumption other than nalbuphine in mg.
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24 hours postoperatively
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•Heart Rate (HR)
Time Frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
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Heart Rate in beats /min
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Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
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•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
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Mean Arterial Pressure in mmHg
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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
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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.
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24 hours postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
Other Study ID Numbers
- ABC-3-DE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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