The analgesic efficacy and safety of nefopam in patient-controlled analgesia after breast reconstruction surgery: A randomized, double-blind, non-inferiority study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006970

Enrollment

120

Registered

2022-01-27

Start date

2022-02-07

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Patients are assigned to one of three PCA groups using a randomization plan generator (available at http://www.randomizer.org) : Fentanyl only

nefopam + fentanyl

nefopam only. Group F : Fentanyl (10microgram/kg) mixed normal saline, total 100ml Group FN : Fentanyl (5microgram/kg) + Nefopam 100 mg mixed to normal saline, total 100 ml Group N : Nefopam 100 m

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) age over 20 and under 75 years old female patients 2) patients scheduled to undergo breast cancer resection surgery with immediate reconstruction 3) ASA physical status I-III

Exclusion criteria

Exclusion criteria: 1) History of drug abuse 2) Chronic pain that requires continuous administration of opioids 3) History of seizure or mental illness 4) Bradycardia (Heart rate < 50 beats per minute) or arrhythmia 5) Cardiovascular diseases(coronary artery disease, ischemic heart disease, etc.) other than diabetes and hypertension 6) Moderate to severe renal of hepatic disease 7) Pregnant or breast feeding patients 8) History of allergy to study drugs 9) Fail to give informed consent

Design outcomes

Primary

Measure	Time frame
VAS (Visual Analogue Scale) pain score measured at 12-24 hours after surgery	—

Secondary

Measure	Time frame
(1) VAS measured at 0-1, 1-6, 6-12, 24-48 hours after surgery (2) Total opioids dose used at 0-1, 1-6, 6-12, and 12-24 hours after surgery (3) The first rescue drug injection time from the end of surgery (4) Total infusion dose of intravenous anesthetics and opioids during the surgery (5) Vital sign during surgery (Before induction, at incision, during the surgery, end of the surgery) (6) The number of rescue drug injections during the surgery due to hypotension or bradycardia (7) Adverse event (PONV, hypotension, dyspnea, urinary retention, dizziness	—

Measure

Time frame

(1) VAS measured at 0-1, 1-6, 6-12, 24-48 hours after surgery (2) Total opioids dose used at 0-1, 1-6, 6-12, and 12-24 hours after surgery (3) The first rescue drug injection time from the end of surgery (4) Total infusion dose of intravenous anesthetics and opioids during the surgery (5) Vital sign during surgery (Before induction, at incision, during the surgery, end of the surgery) (6) The number of rescue drug injections during the surgery due to hypotension or bradycardia (7) Adverse event (PONV, hypotension, dyspnea, urinary retention, dizziness

—

Countries

Korea, Republic of

Contacts

Public ContactWonjung Hwang

The Catholic University of Korea, Seoul St. Mary's Hospital

amoeba97@naver.com+82-2-2258-6162

Outcome results