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Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

Not Applicable
Recruiting
Conditions
Modified Radical Mastectomy
Erector Spinae Plane Block
Interventions
Drug: Erector spinae plane block(15 ml bupivacaine 0.5%)
Drug: Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)
Registration Number
NCT06498739
Lead Sponsor
Cairo University
Brief Summary

Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Detailed Description

Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.

Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block). Ultrasound guided erector spinae plane block (ESPB) was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
52
Inclusion Criteria
  • Age from 18 to 60 years.
  • Genders eligible for study: female sex.
  • American Society of Anesthesiologists (ASA) I-II.
  • Undergoing modified radical mastectomy.
  • Body mass index (BMI) from 18.5 to 30 kg.
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Exclusion Criteria
  • Patient refusal.
  • Known allergy to local anesthetics .
  • Bleeding disorders; platelets count <50,000 ,prothrombin concentration < 60% or any coagulopathy disorder.
  • Use of any anti-coagulants .
  • Inability to provide informed consent.
  • Neurological disorders.
  • Patient with psychiatric disorders.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Erector Spinae Plane block (high concentration-low volume)Erector spinae plane block(15 ml bupivacaine 0.5%)Patients will preoperatively receive high concentration-low volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patient).
Erector Spinae Plane block (low concentration-high volume)Erector spinae plane block (15 ml bupivacaine 0.5% and 15ml normal saline)Patients will preoperatively receive low concentration-high volume ultrasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient.
Primary Outcome Measures
NameTimeMethod
Total morphine consumption24 hours postoperative

Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").

Secondary Outcome Measures
NameTimeMethod
Time 1st rescue analgesia24 hours postoperative

All patients will receive paracetamol 1gm and intravenous ketorolac 30mg will be provided as a part of multimodal analgesia. Rescue analgesia will be provided in the form of intravenous morphine 3 mg boluses if the patient indicates visual analogue scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Visual Analogue Scale (VAS) (0 represents "no pain" while 10 represents "the worst pain imaginable").

Pain score24 hours postoperative

Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").it will be assess at 0 , 4, 8, 12, 16, 20 and 24 hours postoperatively.

Trial Locations

Locations (1)

Cairo Univesity

🇪🇬

Cairo, Egypt

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