Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

Evaluation of the Effect of Serratus Anterior Block and Erector Spinae Block on Postoperative Analgesia in Thoracic Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: Bupivacaine; Procedure: Serratus anterior block (SAB); Procedure: Erector spinae block; Drug: Saline (as a placebo)

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: serratus anterior block; serratus anterior block with 20 ml bupivacaine	Drug: Bupivacaine; bupivacaine; Procedure: Serratus anterior block (SAB); Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%; Other Names: SAB group
EXPERIMENTAL: erector spinae block; erector spinae block with 20 ml bupivacaine	Drug: Bupivacaine; bupivacaine; Procedure: Erector spinae block; Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%; Other Names: ESB group
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption in first postoperative 24 hours	the amount of morphine required to relieve pain will be recorded	first 24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative fentanyl requirement	the amount of fentanyl required during anaesthesia will be recorded	during anaesthesia
numerical rating scale	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	the first 24 postoperative hours
pulmonary functions	FVC and FEV1 will be recorded at 24 hours after surgery	24 hours after surgery

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Mohamed E Hassan, MS, National Cancer Institute - Vairo University - Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Erector spinae block; Serratus anterior block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: AP2007-50105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No