Skip to content

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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05410158
Enrollment
60
Registered
2022-06-08
Start date
2023-05-15
Completion date
2023-08-15
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGKetamine 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 .

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026