PECS Block With Bupivacaine Vs Bupivacaine and Dexmedetomidine in Modified Radical Mastectomy

NCT04284098 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-02-25

No results posted yet for this study

Summary

The incidence of breast cancer as well as the need for surgical treatment has increased.

Breast cancer surgery (BCS) is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting (PONV), delayed hospital discharge.

Acute postoperative pain is an integral risk factor in the development of chronic pain after BCS.

Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction.

General anesthesia (GA) is the technique that commonly used for breast surgeries. The downside of GA includes inadequate pain control with high incidence of PONV . Also postoperative opioid for postoperative pain usually associated with many complications Regional anesthesia for breast surgery holds a great promise for breast cancer patients in terms of improved acute pain control with chronic pain prevention. It offers adequate analgesia while minimizing opioid consumption.

This study was designed in order to assess the efficacy and safety of PECS block as a supplement to GA in modified radical mastectomy (MRM) . Also to assess its role in decreasing the amount of opioid in the intra- and postoperative period after MRM. Also to assess its role in decreasing postoperative complications after BCS such as postoperative nausea and vomiting, delayed hospital discharge,and acute postoperative pain. Also to assess the role of dexmedetomidine in prolongation of the analgesic effect of PECS block.

Conditions

  • Anesthesia

Interventions

OTHER

General anesthesia (GA).

Patients received standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.

OTHER

PECS block using bupivacaine .

The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%, after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.

OTHER

PECS block using bupivacaine and dexmedetomidine

D group:The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%+dexmedetomidine (1µg/kg) after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Doaa M Farid, MD · Faculty of medicine,Zagazig university,Egypt

  • Maha I El desouky, MD · Faculty of medicine,Zagazig university,Egypt

  • Fatma M Ahmed, MD · Faculty of medicine,Zagazig university,Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-06-01
Completion
2020-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04284098 on ClinicalTrials.gov