Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery

NCT03480308 | Unknown

• 1 other identifier: paravertebral block
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the analgesic efficacy of fentanyl and dexamethasone in combination with bupivacaine for single-shot paravertebral block (PVB) in patients undergoing major breast surgery.

Conditions

Paravertebral Block

Outcome Measures

Primary Outcomes (2)

• Time to first analgesic request

  one day postoperative

• pain assessment

  Pain assessment by the aid of Visual analogue scale (VAS) Ranging from 0=no pain, 10=excruciating pain higher values represent worse outcome

  one day postoperatively

Study Arms (3)

Bupivacaine fentanyl group

ACTIVE COMPARATOR

Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block

Drug: Fentanyl; Drug: Bupivacaine

Bupivacaine dexamethasone group

ACTIVE COMPARATOR

Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block

Drug: Dexamethasone; Drug: Bupivacaine

Bupivacaine fentanyl dexamethasone group

ACTIVE COMPARATOR

Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block

Drug: Fentanyl; Drug: Dexamethasone; Drug: Bupivacaine

Interventions

Fentanyl DRUG

Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block

Bupivacaine fentanyl dexamethasone group; Bupivacaine fentanyl group

Dexamethasone DRUG

Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block

Bupivacaine dexamethasone group; Bupivacaine fentanyl dexamethasone group

Bupivacaine DRUG

Bupivacaine

Bupivacaine dexamethasone group; Bupivacaine fentanyl dexamethasone group; Bupivacaine fentanyl group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years.
• Sex: females
• ASA physical status: I-II.
• Operation: major breast surgery

You may not qualify if:

• \- Patient refusal.
• History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
• Coagulation disorders.
• Infection at the puncture site
• Allergy to study medications.
• Chronic use of pain medications.
• Respiratory tract in¬fection within the last 2 weeks.
• Neurological deficit

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Amonios Khalil gerges

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl; Dexamethasone; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amonios khalil

  Faculty of medicine-Assiut university-Egypt

  STUDY DIRECTOR

Central Study Contacts

Amonios khalil

CONTACT

01023466456; amonios_khalil@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization Will be Done Using Computer Generated Tables
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: Patients will receive ultrasound guided paravertebral block and stratified into 3 groups according to medication used : Group 1 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg Group 2 : bupivacaine (0.5%) 20 ml , dexamethasone 4 mg Group 2 : bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 29, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: March 30, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

EG (1)