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The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Mastectomy.

T

Tanta University

Status

Unknown

Conditions

Mastectomy
Serratus Plane Block
Rhomboid Intercostal Block

Treatments

Other: Rhomboid intercostal nerve block (RIB)
Other: Serratus Plane Block (SPB)

Study type

Interventional

Funder types

Other

Identifiers

NCT05156775
34981/10/21

Details and patient eligibility

About

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.

Full 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

Enrollment

105 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 3 patient groups

Intravenous analgesia group
No Intervention group
Description:
35 Patients will receive intravenous morphine (mg) analgesia only.
Serratus Plane Block (SPB) group
Experimental group
Description:
35 Patients will receive ipsilateral serratus plane block using 30 ml bupivacaine 0.25% at the level of the 5th rib.
Treatment:
Other: Serratus Plane Block (SPB)
Rhomboid intercostal nerve block (RIB) group
Experimental group
Description:
35 Patients will receive ipsilateral rhomboid intercostal nerve block using 30 ml bupivacaine 0.25%.
Treatment:
Other: Rhomboid intercostal nerve block (RIB)

Trial contacts and locations

1

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Central trial contact

Dina H. Alhassanin, M.B.B.CH

Data sourced from clinicaltrials.gov

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