Comparative Study of Ketamine Added to Bupivacaine in PECS Block Versus Topical Wound Instillation on Post Operative Analgesia in Modified Radical Mastectomy Surgery

Study Overview
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Brief Summary
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Comparative study of ketamine added to bupivacaine in PECS block versus topical wound instillation on post operative analgesia in modified radical mastectomy surgery

Official Title
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Comparative Study of Ketamine Added to Bupivacaine in PECS Block Versus Topical Wound Instillation on Post Operative Analgesia in Modified Radical Mastectomy Surgery

Conditions
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Ketamine, Pecs Block, Topical Wound Instillation , Modefied Radical Mastectomy

Intervention / Treatment
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* Drug: Ketamine in PECS block versus topical wound instillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1) female patients aged 18 - 60 years, 2) American Society of Anesthesiologists (ASA) class | , || , ||| 3) With body weight of 50 - 90 kg . 4) female patients diagnosed with cancer breast and scheduled for modified radical mastectomy . 5) patients not known to be allergic to any of the medications used in the study. Exclusion Criteria: - 1) patients with known allergy to the study drugs . 2) patients with significant cardiac, respiratory, renal or hepatic disease . 3) patients with drug or alcohol abuse . 4) patients with psychiatric illness that would interfere with perception and assessment of pain. 5) Patients with a history of bleeding diathesis; opioid dependence; sepsis; prior surgery in the supraclavicular, infraclavicular or axillary regions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pecs block group<br>The Pecs block will be performed while the patient in the supine position with the ipsilateral upper limb abducted 90 degree with an 80 mm 21 G needle (Pajunk®SonoPlex Stim cannula U.S.A) using linear array ultrasound probe of high frequency (Sonosite®, Inc. U.S.A) starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line . Patients will be given ultrasound guided, modified Pecs block with 30 mL of 0.25% bupivacaine hydrochloride (Markyrene ®Sigma Tec, Egypt) plus ketamine hydrochloride (1 mg/kg) (Ketamine® Sigma-Tec, Egypt) injected between the pectoralis minor and the serratus anterior muscles , and skin incision will be performed 15 minutes after the block was given. | Drug: Ketamine in PECS block versus topical wound instillation<br>* On arrival to the operating room, an intravenous line will be inserted in the contralateral upper limb to the side of surgery. Anesthesia will be induced for all participating patients with 2 μg/kg fentanyl, 2 - 3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation will be facilitated by 0.15 mg/kg cis-atracurium.The patients will be randomly assigned into 2 groups ( pecs block group , topical instillation group) using a randomization-computer program . Anesthesia will be maintained by 1 - 1.5 MAC isoflurane in 50% oxygen/ air mixture and 0.03 mg/kg cisatrcurium, respectively, in ventilation parameters that maintain normocapnia. At the end of surgery, a reversal of the muscle relaxant will be done using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After extubation, all patients will be transmitted to the post anesthesia care unit (PACU) for follow up .<br>|
| Other: Topical instillation group:<br>After surgical hemostasis before wound closure Patients will receive 1 mg/kg ketamine hydrochloride plus 30 mL of 0.25% bupivacaine hydrochloride which will be put in asterile syringe and irrigated onto the surgical field at the end of surgery . | Drug: Ketamine in PECS block versus topical wound instillation<br>* On arrival to the operating room, an intravenous line will be inserted in the contralateral upper limb to the side of surgery. Anesthesia will be induced for all participating patients with 2 μg/kg fentanyl, 2 - 3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation will be facilitated by 0.15 mg/kg cis-atracurium.The patients will be randomly assigned into 2 groups ( pecs block group , topical instillation group) using a randomization-computer program . Anesthesia will be maintained by 1 - 1.5 MAC isoflurane in 50% oxygen/ air mixture and 0.03 mg/kg cisatrcurium, respectively, in ventilation parameters that maintain normocapnia. At the end of surgery, a reversal of the muscle relaxant will be done using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After extubation, all patients will be transmitted to the post anesthesia care unit (PACU) for follow up .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The primary outcome measure in this study will be the total dose of morphine consumption during the 48 hours Postoperatively. |  | july 2022 - feb 2023 |