Clinical trial NCT05156775: The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Mastectomy.
Official title: The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mastectomy
Rhomboid Intercostal Block
Serratus Plane Block
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The total rescue morphine (mg) consumption in the first 24 post-operative hours.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Post-operative pain assessed by visual analog scale (VAS)
timeFrame: 24 hours Postoperative
measure: Heart rate
timeFrame: Intraoperative
measure: Mean arterial blood pressure
timeFrame: Intraoperative
measure: Time to first rescue analgesic request (minutes)
timeFrame: 24 hours Postoperative
measure: Intraoperative fentanyl consumption (µg).
timeFrame: Intraoperative
measure: Adverse effects
timeFrame: intraoperative or 24 hours Postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Elgharbia
Study officials:
References: