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

A

Assiut University

Status

Unknown

Conditions

Paravertebral Block

Treatments

Drug: Dexamethasone
Drug: Fentanyl
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03480308
paravertebral block

Details and patient eligibility

About

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.

Full description

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.

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

Enrollment

1 estimated patient

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

    • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 3 patient groups

Bupivacaine fentanyl group
Active Comparator group
Description:
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
Treatment:
Drug: Bupivacaine
Drug: Fentanyl
Bupivacaine dexamethasone group
Active Comparator group
Description:
Patients will receive bupivacaine (0.5%) 20 ml , dexamethasone 4 mg in paravertebral block
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine
Bupivacaine fentanyl dexamethasone group
Active Comparator group
Description:
Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg , dexamethasone 4 mg in paravertebral block
Treatment:
Drug: Dexamethasone
Drug: Bupivacaine
Drug: Fentanyl

Trial contacts and locations

1

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Central trial contact

Amonios khalil

Data sourced from clinicaltrials.gov

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