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Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT04579302
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Egypt

Study Description
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Brief Summary:
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block and erector spinae block and control group. during anaesthesia:total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Procedure: Serratus anterior block (SAB) Procedure: Erector spinae block Drug: Saline (as a placebo) Drug: Bupivacaine Not Applicable

Detailed Description:
90 patients scheduled for thoracic cancer surgeries, allocated in 3 groups for serratus anterior block (SAB) and erector spinae block (ESB) and control group. During anaesthesia: total intraoperative fentanyl required will be recorded. After surgery, all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are: numerical rating scales and postoperative pulmonary functions.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: serratus anterior block
serratus anterior block with 20 ml bupivacaine
 Procedure: Serratus anterior block (SAB)
Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%
Other Name: SAB group

Drug: Bupivacaine
bupivacaine
Experimental: erector spinae block
erector spinae block with 20 ml bupivacaine
 Procedure: Erector spinae block
Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
Other Name: ESB group

Drug: Bupivacaine
bupivacaine
Sham Comparator: control group
sham block with 20 ml saline
 Drug: Saline (as a placebo)
Patients will receive a sham block with 20 ml saline (as a placebo)


Outcome Measures
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Primary Outcome Measures :
  1. total morphine consumption in first postoperative 24 hours [ Time Frame: first 24 postoperative hours ]
    the amount of morphine required to relieve pain will be recorded


Secondary Outcome Measures :
  1. intraoperative fentanyl requirement [ Time Frame: during anaesthesia ]
    the amount of fentanyl required during anaesthesia will be recorded

  2. numerical rating scale [ Time Frame: the first 24 postoperative hours ]
    numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery

  3. pulmonary functions [ Time Frame: 24 hours after surgery ]
    FVC and FEV1 will be recorded at 24 hours after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with class II physical status (American Society of Anaesthesiologists) ,
  • Age between 18-70 years,
  • Scheduled for thoracic cancer surgery

Exclusion Criteria:

  • Patient refusal.
  • Local infection at the site of the block.
  • Cardiac dysfunction (ejection fraction <45%).
  • Significant respiratory disorders.
  • Preexisting neurological or psychiatric disease.
  • Allergy to one of the study drugs.
  • Pregnancy.
  • Coagulopathy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579302


Locations
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Egypt
National Cancer Institute
Cairo, Egypt
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Principal Investigator: Mohamed E Hassan, MS National Cancer Institute - Vairo University - Egypt
More Information
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Responsible Party: National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04579302    
Other Study ID Numbers: AP2007-50105
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Egypt:
Serratus anterior block
Erector spinae block
Postoperative analgesia
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents