Pecs Block vs Local Infiltration in Mastectomy

NCT06451705 | Completed

• 1 other identifier: 173/UN4.6.4.5.31/PP36/2AZ4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

postoperative pain; modified radical mastectomy; peripheral nerve block; local infiltration anesthesia; pectoralis nerve block

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Demographic baseline data

  baseline (before the surgery)

• Time until first rescue opioid requirement

  Within 24 hours after surgery

• Nausea and vomiting

  Within 24 hours after surgery

Study Arms (2)

PECS

ACTIVE COMPARATOR

PECS II block before surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)

Drug: PECS II block

LIA

ACTIVE COMPARATOR

Local infiltration anesthesia after completion of surgery using isobaric bupivacaine 0.25% 20 mL (50 mg)

Drug: LIA

Interventions

PECS II block DRUG

Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg

PECS

LIA DRUG

Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg

LIA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years old.
• Body weight (BW): 50-70 kg.
• Height (TB): 150-170 cm.
• Body mass index (BMI): 18.5-29.9 kg/m2.
• American Society of Anesthesiologists physical status (ASA PS) class I-II.
• Patients undergoing elective MRM surgery under general anesthesia.

You may not qualify if:

• Patients with contraindications to PECS II block.
• Patients with contraindications to LIA.
• Patients with coagulation disorders or receiving anticoagulant therapy.
• Patients with a history of chronic pain.
• Patients with a history of allergy to study materials.
• Patients with a history of previous breast surgery.
• Patient refuses to participate in the study.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

RSUP dr. Wahidin Sudirohusodo

Makassar, South Sulawesi, 90173, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blind randomized trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 11, 2024
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)