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Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy

Not Applicable
Completed
Conditions
Patients Undergoing Modified Radical Mastectomy
Interventions
Procedure: Serratus Anterior Plane Block
Procedure: Lumbar Intrathecal Fentanyl Injection
Registration Number
NCT05352282
Lead Sponsor
Sohag University
Brief Summary

Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .

Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.

Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.

We assumed that SAPB could safely provide a better analgesic profile with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery
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Exclusion Criteria
  • Patient refusal.
  • Patient with significant neurological , psychiatric or neuromuscular disease
  • Alcoholism .
  • Drug abuse .
  • Pregnancy or lactating women .
  • Suspected Coagulopathy .
  • Morbid obesity .
  • Known allergy to study medications .
  • Septicaemia and local infection at the block site.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group ASerratus Anterior Plane Block-
Group BLumbar Intrathecal Fentanyl Injection-
Primary Outcome Measures
NameTimeMethod
analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy1 year

compare the analgesic effect between serratus anterior plane block and lumbar intrathecal fentanyl injection by using visual analogue score (vas).

-Postoperative pain will be assessed using visual analog score (VAS) \[0-10\]. 0 - 3 mild pain 4 - 6 moderate pain 7 - 10 severe pain 10 \<unbearable pain)

Secondary Outcome Measures
NameTimeMethod
Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy1 year

compare between serratus anterior plane block and lumbar intrathecal fentanyl injection as regard, hemodynamics of patient undergoing modified radical mastectomy.

-The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after induction and with skin incision and every 5 minutes intraoperative till the end of surgery. And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.

Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomyone year

compare between serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy as regard intra venous analgesics consumption.

All patients will receive paracetamol (15mg/KG/dose) immediately postoperative and after 6 hours. Patients will be assessed every one hour in the first 6 hours then every 3 hours in the next 18 hours.

Patients will receive ketorolac 30 mg if VAS 3-5 . If VAS\>5 ,morphine 0.1mg/kg will be given then total ketorolac and morphine consumption in 24 hours will be calculated and compared between both groups .

Trial Locations

Locations (1)

Sohag University Hospital

🇪🇬

Sohag, Egypt

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