Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia

NCT04579302 | Completed

• 1 other identifier: AP2007-50105
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia

Keywords

Serratus anterior block; Erector spinae block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• total morphine consumption in first postoperative 24 hours

  the amount of morphine required to relieve pain will be recorded

  first 24 postoperative hours

Secondary Outcomes (3)

• intraoperative fentanyl requirement

  during anaesthesia

• numerical rating scale

  the first 24 postoperative hours

• pulmonary functions

  24 hours after surgery

Study Arms (3)

serratus anterior block

EXPERIMENTAL

serratus anterior block with 20 ml bupivacaine

Procedure: Serratus anterior block (SAB); Drug: Bupivacaine

erector spinae block

EXPERIMENTAL

erector spinae block with 20 ml bupivacaine

Procedure: Erector spinae block; Drug: Bupivacaine

control group

SHAM COMPARATOR

sham block with 20 ml saline

Drug: Saline (as a placebo)

Interventions

Serratus anterior block (SAB) PROCEDURE

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

Also known as: SAB group

serratus anterior block

Erector spinae block PROCEDURE

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

Also known as: ESB group

erector spinae block

Saline (as a placebo) DRUG

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

control group

Bupivacaine DRUG

bupivacaine

erector spinae block; serratus anterior block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Interventions

Sodium Chloride; Bupivacaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mohamed E Hassan, MS

  National Cancer Institute - Vairo University - Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 8, 2020
• Study Start: November 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)