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

February 21, 2020 updated by: Thorya Mohammed Salem, Zagazig University

Ultrasound Guided Pectoral Nerve Block Using Bupivacaine Versus Bupivacaine and Dexmedetomidine as a Supplement to General Anesthesia in Modified Radical Mastectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most frequent cancer among women; it causes the highest number of cancer-related deaths among them globally. The prognosis has improved considerably over the past 30 years, and the 5-year survival rate of patients has been increased due to the advances in the early detection and treatment of breast cancer.

Breast cancer surgery is associated with many complications such as increased incidence of acute and chronic postoperative pain, postoperative nausea and vomiting, delayed hospital discharge, and cancer recurrence. One of the most important complications is the occurrence of acute postoperative pain. Acute postoperative pain is an integral risk factor in the development of chronic pain after breast cancer surgery (BCS).

Inadequate pain control can impact patient recovery including impaired pulmonary and immune function with an increased risk of ileus, thromboembolism, and myocardial infarction. These factors can further increase the hospital length of stay, increase the healthcare costs, and decrease the patient satisfaction.

General anesthesia, including intravenous and inhalational agents, is the technique that commonly used for breast surgeries. The drawbacks of general anesthesia include inadequate pain control with high incidence of nausea and vomiting. Also the use of opioid and non-opioid analgesics 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 and its related side effects.

Several techniques of blocks for breast surgery have been described. Thoracic epidural and paravertebral blocks were the gold standard techniques to achieve this goal. However, these techniques are generally performed before general anesthesia, and not all anesthesiologists feel comfortable using such invasive procedures in BCS. AS an alternative for these techniques, pectoral nerves (PECS) block has been reported as a promising technique during BCS.

PECS block is an interfascial peripheral nerve block described since 2011.The original block is PECS I block, in which local anesthetic is deposited between the pectoralis major and pectoralis minor muscles to block the lateral pectoral nerve (C5, 6, 7) and medial pectoral nerve (C8, T1) providing analgesia to the anterior chest wall.

PECS II block is a modified PECS I. In this block, local anesthetic is injected between the serratus anterior and pectoralis minor muscle at the third rib in addition to the original block aimed to block thoracic intercostal nerves (T2-6) including intercostobrachial nerve and long thoracic nerve (C5-C7). This modification aimed to extend analgesia to the axilla; this is needed for axillary clearance, necessary for wide excisions, tumorectomy, lymph node excision and several types of mastectomies.

It differs from thoracic epidural and paravertebral blocks as there is no associated sympathetic block. It can be performed while the patient in the supine position and it can be done before or after induction of general anesthesia.

The use of ultrasound (US) makes the pectoral nerve block more accurate and less injurious to nearby structures such as the parietal pleura. It helps direct visualization of anatomical structures, it finds the possible variations in the origin, course, the accompanying structures of the medial and lateral pectoral nerves and their relation to the important structures such thoracoacromial artery and parietal pleura to avoid their injury during performing the PECS block.

The addition of dexmedetomidine to bupivacaine can improve the quality of the block, significantly prolong the duration of analgesia, and provides better pain control postoperatively without major side effects.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Thorya M Salem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: GA group
Group I (GA group): Standard general anesthesia (GA) .
Other: General anesthesia (GA).
Patients received standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
Active Comparator: Bupivacaine group
Group II (B group): ultrasound-guided PECS block using bupivacaine 0.25% + standard GA.
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.
Active Comparator: Dexmedetomidine&bupivacaine group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total intraoperative opioid consumption.
Time Frame: During operation.
Total intraoperative fentanyl.
During operation.
Total postoperative opioid consumption.
Time Frame: First 24 hours after surgery.
Total postoperative morphine consumption.
First 24 hours after surgery.
First time to rescue analgesia.
Time Frame: First 24 hours after surgery.
Duration of postoperative analgesia.
First 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score.
Time Frame: 0.3,6,9,12, and 24 hours after surgery.
Visual analogue scale (VAS) which is a unidimensional measure of pain intensity, it is a 10 cm line ranging from (0=no pain to 10 = worst pain imaginable) . The patient is asked to mark on this line where the intensity of the pain lies.
0.3,6,9,12, and 24 hours after surgery.
Postoperative nausea &vomiting
Time Frame: First 24 hours after surgery.
postoperative nausea &vomiting (yes or no)
First 24 hours after surgery.
Hospital length of stay.
Time Frame: First 3 days after surgery.
days until the patients are discharged to home.
First 3 days after surgery.
Patients and surgeon satisfaction
Time Frame: First 24 hours after surgery.
Surgeon satisfaction is assessed by Surgeon Satisfaction with Anesthesia Services (SSAS) the scale was composed of four levels (Strongly disagree, Disagree, Agree, strongly agree) ,Patient satisfaction (yes or no).
First 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Chair: Doaa M Farid, MD, Faculty of medicine,Zagazig University,Egypt
  • Study Chair: Maha I El desouky, MD, Faculty of medicine,Zagazig University,Egypt
  • Study Director: Fatma M Ahmed, MD, Faculty of medicine,Zagazig University,Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PECS in Breast Cancer Surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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