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Completed

NCT Number: NCT06451705

Pecs Block vs Local Infiltration in Mastectomy

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUP dr. Wahidin Sudirohusodo

Makassar, South Sulawesi, 90173, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PECS II block

Drug

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

LIA

Drug

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

Primary outcomes

  1. Concentration of Plasma Interleukin-6

    Time frame: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery

    in pg/dL

  2. Neutrophil-lymphocyte ratio

    Time frame: 1 hour before surgery, 2 hour after surgery, 12 hour after surgery

    Neutrophil divided by lymphocyte

  3. Pain intensity (Using Numeric Rating Scale)

    Time frame: hour 0, 2, 4, 6, 12, 24

    Scale from 0-10, lower score = better outcome

  4. Rescue opioid requirement

    Time frame: 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 outcomes

  1. Demographic baseline data

    Time frame: 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)

  2. Time until first rescue opioid requirement

    Time frame: Within 24 hours after surgery

    in minutes

  3. Nausea and vomiting

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Acronym: PBLIM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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