Pain, Postoperative
Conditions
Keywords
postoperative pain, modified radical mastectomy, peripheral nerve block, local infiltration anesthesia, pectoralis nerve block
Brief summary
Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.
Interventions
DRUGPECS II block
Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg
DRUGLIA
Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
single-blind randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 18-60 years old. 2. Body weight (BW): 50-70 kg. 3. Height (TB): 150-170 cm. 4. Body mass index (BMI): 18.5-29.9 kg/m2. 5. American Society of Anesthesiologists physical status (ASA PS) class I-II. 6. Patients undergoing elective MRM surgery under general anesthesia.
Exclusion criteria
1. Patients with contraindications to PECS II block. 2. Patients with contraindications to LIA. 3. Patients with coagulation disorders or receiving anticoagulant therapy. 4. Patients with a history of chronic pain. 5. Patients with a history of allergy to study materials. 6. Patients with a history of previous breast surgery. 7. Patient refuses to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Plasma Interleukin-6 | 1 hour before surgery, 2 hour after surgery, 12 hour after surgery | in pg/dL |
| Neutrophil-lymphocyte ratio | 1 hour before surgery, 2 hour after surgery, 12 hour after surgery | Neutrophil divided by lymphocyte |
| Pain intensity (Using Numeric Rating Scale) | hour 0, 2, 4, 6, 12, 24 | Scale from 0-10, lower score = better outcome |
| Rescue opioid requirement | Within 24 hours after surgery | Using fentanyl at a dose of 0.5-1 μg/kg/IV titrated as needed, in mcg (given if the patient had NRS of \>4/10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time until first rescue opioid requirement | Within 24 hours after surgery | in minutes |
| Nausea and vomiting | Within 24 hours after surgery | Nausea and vomiting were assessed using a numerical scale (0 = no nausea, 1 = mild nausea, 2 = severe nausea or vomiting once, and 3 = vomiting more than once). If the score was \> 2, rescue antiemetics with ondansetron 0.1 mg/IV were given. |
| Demographic baseline data | baseline (before the surgery) | Medical record number, age, body weight (in kilogram), height (in centimeter), BMI (in kg/m2), ASA PS class, duration of surgery (in minutes) |
Countries
Indonesia
Outcome results
None listed