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

Early Phase 1

Not yet recruiting

• Conditions: Ketamine, Pecs Block, Topical Wound Instillation , Modefied Radical Mastectomy
• Interventions: Drug: Ketamine in PECS block versus topical wound instillation

• Registration Number: NCT05410158
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-05-14
• Study Start: 2023-05-15
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-07-28
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pecs block group	Ketamine in PECS block versus topical wound instillation	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.
Topical instillation group:	Ketamine in PECS block versus topical wound instillation	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 .

Primary Outcome Measures

Name	Time	Method
- The primary outcome measure in this study will be the total dose of morphine consumption during the 48 hours Postoperatively.	july 2022 - feb 2023