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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmetomedine as an Adjuvant to Bupivacaine in Ultrasound Guided PECS Block

NCT05717114

Post Operative Pain

COMPLETED NA

Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries

NCT05591417

Analgesia

COMPLETED NA

Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management

NCT06022614

Erector Spinae Plane Block

COMPLETED NA

Comparing Effect of Adding Ketamine Versus Dexmedetomidine to Bupivacaine in Pec 11 Modified Block on Postoperative Pain Control in Patients Undergoing Breast Surgery

NCT04380168

More Effective Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination More Prolonged Duration of Postoperative Analgesia After Modified Radical Mastectomy With Better Drug Combination

COMPLETED PHASE3

Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

NCT05385523

Postoperative Pain, Acute

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GA group

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

Group Type PLACEBO_COMPARATOR

General anesthesia (GA).

Intervention Type OTHER

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

Bupivacaine group

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

Group Type ACTIVE_COMPARATOR

PECS block using bupivacaine .

Intervention Type 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.

Dexmedetomidine&bupivacaine group

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

Group Type ACTIVE_COMPARATOR

PECS block using bupivacaine and dexmedetomidine

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

General anesthesia (GA).

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No