Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
- Conditions
- Postoperative Pain
- Interventions
- Procedure: Serratus Anterior Plane Block TechniqueProcedure: General anesthesia
- Registration Number
- NCT04544228
- Lead Sponsor
- Cairo University
- Brief Summary
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
- Detailed Description
Breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in Egypt. Modified Radical Mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases.
Ultrasound guided Serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve and thoracodorsal nerve).
A previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption.
Neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. Although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear.
The aim of this study is to Investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in Ultrasound guided Serratus anterior plane block for patients undergoing Modified Radical Mastectomy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
-
● Female patients
- Type of surgery; Modified Radical Mastectomy (MRM).
- Physical status ASA II, III.
- Age ≥ 21 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
-
● Patients with Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain.
- Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- Infection of the skin at the site of needle puncture area
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Pregnancy.
- Patient with surgery duration more than two hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine Serratus Anterior Plane Block Technique Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine ketamine General anesthesia Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine Neostigmine Serratus Anterior Plane Block Technique Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine Neostigmine General anesthesia Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine Control Serratus Anterior Plane Block Technique Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline. Control General anesthesia Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline. ketamine bupivacaine +ketamine Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml ketamine Control bupivacaine +saline Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml normal saline. Neostigmine bupivacaine + neostigmine Patients will receive Ultrasound guided Serratus Anterior Plane Block preoperative with injection of 30 ml bupivacaine 0.25% + 1 ml neostigmine
- Primary Outcome Measures
Name Time Method Time of first request of analgesia 24 hours postoperative it will be calculated from the time of complete injection of local anesthetics till the numerical rating scale (NRS) is ≥3.
- Secondary Outcome Measures
Name Time Method Numeric Pain Rating Scale 24 hours A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
The total amount of morphine consumption 24 hours postoperative Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 3. The total amount of morphine given in 24 hours will be recorded for the three groups.
Total amount of intraoperative fentanyl. 2 hours Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Trial Locations
- Locations (1)
Faculty of medicine-Cairo University
🇪🇬Cairo, Egypt