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Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

Primary Purpose

Postoperative Analgesia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Serratus anterior block (SAB)

Erector spinae block

Saline (as a placebo)

Bupivacaine

About this trial

This is an interventional supportive care trial for Postoperative Analgesia focused on measuring Serratus anterior block, Erector spinae block, Postoperative analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

serratus anterior block

erector spinae block

control group

Arm Description

serratus anterior block with 20 ml bupivacaine

erector spinae block with 20 ml bupivacaine

sham block with 20 ml saline

Outcomes

Primary Outcome Measures

total morphine consumption in first postoperative 24 hours

the amount of morphine required to relieve pain will be recorded

Secondary Outcome Measures

intraoperative fentanyl requirement

the amount of fentanyl required during anaesthesia will be recorded

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

pulmonary functions

FVC and FEV1 will be recorded at 24 hours after surgery

Full Information

NCT ID

NCT04579302

First Posted

September 24, 2020

Last Updated

March 8, 2021

Sponsor

National Cancer Institute, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT04579302

Brief Title

Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Analgesia

Keywords

Serratus anterior block, Erector spinae block, Postoperative analgesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

serratus anterior block

Arm Type

Experimental

Arm Description

serratus anterior block with 20 ml bupivacaine

Arm Title

erector spinae block

Arm Type

Experimental

Arm Description

erector spinae block with 20 ml bupivacaine

Arm Title

control group

Arm Type

Sham Comparator

Arm Description

sham block with 20 ml saline

Intervention Type

Procedure

Intervention Name(s)

Serratus anterior block (SAB)

Other Intervention Name(s)

SAB group

Intervention Description

Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%

Intervention Type

Procedure

Intervention Name(s)

Erector spinae block

Other Intervention Name(s)

ESB group

Intervention Description

Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%

Intervention Type

Drug

Intervention Name(s)

Saline (as a placebo)

Intervention Description

Patients will receive a sham block with 20 ml saline (as a placebo)

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

bupivacaine

Primary Outcome Measure Information:

Title

total morphine consumption in first postoperative 24 hours

Description

the amount of morphine required to relieve pain will be recorded

Time Frame

first 24 postoperative hours

Secondary Outcome Measure Information:

Title

intraoperative fentanyl requirement

Description

the amount of fentanyl required during anaesthesia will be recorded

Time Frame

during anaesthesia

Title

numerical rating scale

Description

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

Time Frame

the first 24 postoperative hours

Title

pulmonary functions

Description

FVC and FEV1 will be recorded at 24 hours after surgery

Time Frame

24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed E Hassan, MS

Organizational Affiliation

National Cancer Institute - Vairo University - Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Institute

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

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