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

NCT04284098 | Unknown

• 1 other identifier: PECS in Breast Cancer Surgery
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Total intraoperative opioid consumption.

  Total intraoperative fentanyl.

  During operation.

• Total postoperative opioid consumption.

  Total postoperative morphine consumption.

  First 24 hours after surgery.

• First time to rescue analgesia.

  Duration of postoperative analgesia.

  First 24 hours after surgery.

Secondary Outcomes (4)

• Postoperative pain score.

  0.3,6,9,12, and 24 hours after surgery.

• Postoperative nausea &vomiting

  First 24 hours after surgery.

• Hospital length of stay.

  First 3 days after surgery.

• Patients and surgeon satisfaction

  First 24 hours after surgery.

Study Arms (3)

GA group

PLACEBO COMPARATOR

Group I (GA group): Standard general anesthesia (GA) .

Other: General anesthesia (GA).

Bupivacaine group

ACTIVE COMPARATOR

Group II (B group): ultrasound-guided PECS block using bupivacaine 0.25% + standard GA.

Other: PECS block using bupivacaine .

Dexmedetomidine&bupivacaine group

ACTIVE COMPARATOR

Group III (D group): ultrasound-guided PECS block using bupivacaine 0.25% and Dexmedetomidine 1µg/kg+standard GA.

Other: PECS block using bupivacaine and dexmedetomidine

Interventions

General anesthesia (GA). OTHER

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

GA group

PECS block using bupivacaine . OTHER

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.

Bupivacaine group

PECS block using bupivacaine and dexmedetomidine OTHER

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.

Dexmedetomidine&bupivacaine group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized for modified radical mastectomy. American Society of Anesthesiologists (ASA), physical status II. Age between 21-65 year.

You may not qualify if:

• Patient's refusal. Preexisting coagulopathy or anti-coagulant therapy. Local infection at site of injection. Pregnancy or breast feeding. Body Mass Index (BMI) \> 35kg/m². Allergy to local anesthetics and drugs used. Prior breast surgery except for diagnostic biopsies.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Thorya M Salem

Zagazig, Egypt

Location

Related Publications (5)

• Battista C, Krishnan S. Pectoralis Nerve Block. 2023 Jul 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK547691/

  PMID: 31613471 BACKGROUND

• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

  PMID: 27543533 BACKGROUND

• Besch G, Lagrave-Safranez C, Ecarnot F, De Larminat V, Gay C, Berthier F, Samain E, Pili-Floury S. Pectoral nerve block and persistent pain following breast cancer surgery: an observational cohort study. Minerva Anestesiol. 2018 Jun;84(6):769-771. doi: 10.23736/S0375-9393.18.12544-2. Epub 2018 Feb 15. No abstract available.

  PMID: 29469548 BACKGROUND

• Campos M, Azevedo J, Mendes L, Rebelo H. Pectoral nerve block as a single anesthetic technique for breast surgery and sentinel lymph node investigation. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Nov;65(9):534-536. doi: 10.1016/j.redar.2018.05.005. Epub 2018 Jul 21. English, Spanish.

  PMID: 30037430 BACKGROUND

• Turbitt L, Nelligan K, McCartney C. Pectoral Nerve Blocks for Breast Cancer Surgery: A Methodological Evaluation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388-9. doi: 10.1097/AAP.0000000000000226. No abstract available.

  PMID: 26079354 BACKGROUND

MeSH Terms

Interventions

Anesthesia, General; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Doaa M Farid, MD

  Faculty of medicine,Zagazig university,Egypt

  STUDY CHAIR

• Maha I El desouky, MD

  Faculty of medicine,Zagazig university,Egypt

  STUDY CHAIR

• Fatma M Ahmed, MD

  Faculty of medicine,Zagazig university,Egypt

  STUDY DIRECTOR

Central Study Contacts

Thorya M Salem, MSc

CONTACT

+201006995112; dr_2010@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 25, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)