Pecs Block vs Local Infiltration in Mastectomy (PBLIM)

Comparison Between Pectoral Nerve Block II and Local Anesthesia Infiltration of Isobaric Bupivacaine 0.25% 50 MG on Neutrophil-Lymphocyte Ratio, Interleukin-6 Levels, Pain Intensity, and Post-surgical Opioid Requirements in Modified Radical Mastectomy Patients

Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: PECS II block; Drug: LIA

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Sulawesi Selatan
    • Makasar, Sulawesi Selatan, Indonesia, 90173
      • RSUP dr. Wahidin Sudirohusodo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PECS; PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)	Drug: PECS II block; Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg
Active Comparator: LIA; Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)	Drug: LIA; Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Plasma Interleukin-6	in pg/dL	1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Neutrophil-lymphocyte ratio	Neutrophil divided by lymphocyte	1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Pain intensity (Using Numeric Rating Scale)	Scale from 0-10, lower score = better outcome	hour 0, 2, 4, 6, 12, 24
Rescue opioid requirement	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)	Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic baseline data	Medical record number, age, body weight (in kilogram), height (in centimeter), BMI (in kg/m2), ASA PS class, duration of surgery (in minutes)	baseline (before the surgery)
Time until first rescue opioid requirement	in minutes	Within 24 hours after surgery
Nausea and vomiting	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.	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; modified radical mastectomy; local infiltration anesthesia; peripheral nerve block; pectoralis nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 173/UN4.6.4.5.31/PP36/2AZ4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No