The Effect of Perioperative Nefopam on Postoperative Pain After Mastectomy: A Randomized Controlled Trial

Phase 4

Active, not recruiting

• Conditions: Breast cancerPostmastectomy pain; Breast cancer; Mastectomy; Nefopam; Postmastectomy pain

• Registration Number: TCTR20200806006
• Lead Sponsor: Ratchadapisek Sompoch Endowment Fund, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Study Completion: 2022-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

1. Diagnosed with breast cancer
2. Undergoing unilateral simple mastectomy, modified radical mastectomy, radical mastectomy, skin sparing mastectomy, nipple sparing mastectomy with or without axillary lymphnode dissection
3. ASA physical status I-III

Exclusion Criteria

1. Patient refusal
2. Unable to properly use intravenous PCA machine
3. Preexisting chronic pain
4. Currently take analgesic medications within 14 days
5. Currently take monoamine oxidase inhibitor within 14 days
6. Pregnant or lactation
7. Previous surgery (excision or mastectomy) due to breast cancer
8. Medical history of seizure, acute angle-closure glaucoma, myocardial infarction, chronic obstructive pulmonary disease
9. Renal impairment (eGFR lower than 30 mL/min/1.73sq.m.)
10. Acute liver failure or severe liver impairment
11. Contraindicated to any medication using in study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total morphine consumption at 24 hours after surgery collected data from PCA machine in milligram of morphine

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption At post anesthesia care unit, at 6 and 48 hours after surgery collected data from PCA machine in milligram of morphine,Severity of pain At post anesthesia care unit, at 6, 24, and 48 hours after surgery Patient reported as verbal numerical rating scale 0-10,Incidence of chronic post operative pain At 3 months after surgery Patient reported during telephone follow up,Incidence of neuropathic pain At 48 hours and 3 months after surgery Patient reported outcome using Thai DN4 questionaire,Adverse events within 48 hours after surgery Patient reported or observed by health care personnels