Pecs Block vs Local Infiltration in Mastectomy

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: PECS II block; Drug: LIA

• Registration Number: NCT06451705
• Lead Sponsor: Hasanuddin University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2024-05-23
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS	PECS II block	PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)
LIA	LIA	Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.

Trial Locations

Locations (1)

RSUP dr. Wahidin Sudirohusodo; 🇮🇩 Makasar, Sulawesi Selatan, Indonesia