Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

NCT ID: NCT04579302

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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serratus anterior block

serratus anterior block with 20 ml bupivacaine

Group Type EXPERIMENTAL

Serratus anterior block (SAB)

Intervention Type PROCEDURE

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

Bupivacaine

Intervention Type DRUG

bupivacaine

erector spinae block

erector spinae block with 20 ml bupivacaine

Group Type EXPERIMENTAL

Erector spinae block

Intervention Type PROCEDURE

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

Bupivacaine

Intervention Type DRUG

bupivacaine

control group

sham block with 20 ml saline

Group Type SHAM_COMPARATOR

Saline (as a placebo)

Intervention Type DRUG

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

Interventions

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Serratus anterior block (SAB)

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

Intervention Type PROCEDURE

Erector spinae block

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

Intervention Type PROCEDURE

Saline (as a placebo)

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

Intervention Type DRUG

Bupivacaine

bupivacaine

Intervention Type DRUG

Other Intervention Names

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SAB group ESB group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed E Hassan, MS

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute - Vairo University - Egypt

Locations

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National Cancer Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2007-50105

Identifier Type: -

Identifier Source: org_study_id

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