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

NCT ID: NCT05410158

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-08-15

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pecs block group

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.

Group Type: OTHER

Ketamine in PECS block versus topical wound instillation

Intervention Type: DRUG

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 .

Topical instillation group:

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 .

Group Type: OTHER

Ketamine in PECS block versus topical wound instillation

Intervention Type: DRUG

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 .

Interventions

Ketamine in PECS block versus topical wound instillation

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 .

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Saif Eldeen Gamal Khalaf

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Ketamine analgesic efficacy

Identifier Type: -

Identifier Source: org_study_id