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Clinical Trials/NCT05156775
NCT05156775
Unknown
N/A

The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.

Tanta University1 site in 1 country105 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mastectomy
Sponsor
Tanta University
Enrollment
105
Locations
1
Primary Endpoint
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.

Detailed Description

Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population. Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay. The postoperative pain may last \>3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role. Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain. Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
May 29, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Hamdy Alhassanin

Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

Inclusion Criteria

  • Female patients
  • Scheduled for unilateral modified radical mastectomy.
  • Age 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I- II

Exclusion Criteria

  • Patient refusal
  • Coagulation disorders
  • Body mass index \> 35 kg/m2
  • Uncooperative or psychiatric patients
  • Infection at the injection site
  • Patients with a history of allergy to local anesthetics
  • Patients with a history of treatment for chronic pain
  • Previous history of breast surgery or other chest surgery

Outcomes

Primary Outcomes

The total rescue morphine (mg) consumption in the first 24 post-operative hours.

Time Frame: 24 hours postoperative

Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4 repeated with 10 minutes lockout interval till the visual analog scale becomes less than 3 guided with the occurrence of complications as nausea, vomiting, and respiratory depression.

Secondary Outcomes

  • Post-operative pain assessed by visual analog scale (VAS)(24 hours Postoperative)
  • Heart rate(Intraoperative)
  • Time to first rescue analgesic request (minutes)(24 hours Postoperative)
  • Mean arterial blood pressure(Intraoperative)
  • Adverse effects(intraoperative or 24 hours Postoperative)
  • Intraoperative fentanyl consumption (µg).(Intraoperative)

Study Sites (1)

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