Pecs Block vs Local Infiltration in Mastectomy

Pain, Postoperative Clinical Trial

— PBLIM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06451705
• Other study ID #: 173/UN4.6.4.5.31/PP36/2AZ4
• Status: Completed
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2024
• Source: Hasanuddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• PECS II block
Treatment group that received the PECS II block using isobaric bupivacaine 0.5% 50 mg
• LIA
Treatment group that received the local infiltration anesthesia using isobaric bupivacaine 0.5% 50 mg

Locations

Country	Name	City	State
Indonesia	RSUP dr. Wahidin Sudirohusodo	Makasar	Sulawesi Selatan

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Plasma Interleukin-6	in pg/dL	1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Primary	Neutrophil-lymphocyte ratio	Neutrophil divided by lymphocyte	1 hour before surgery, 2 hour after surgery, 12 hour after surgery
Primary	Pain intensity (Using Numeric Rating Scale)	Scale from 0-10, lower score = better outcome	hour 0, 2, 4, 6, 12, 24
Primary	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	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)
Secondary	Time until first rescue opioid requirement	in minutes	Within 24 hours after surgery
Secondary	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