Postoperative Pain
Conditions
Keywords
Postoperative Pain
Brief summary
This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of intravenous nefopam can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
Detailed description
Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam 20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control group will receive intravenous normal saline 50ml at the end of induction and receive intravenous normal saline 50ml at a rate of 2ml/hr.
Interventions
DRUGNefopam 80mg/day
continuous nefopam infusion
DRUGNormal saline
continuous normal saline infusion
Sponsors
Pharmbio Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes assessor not involved in this study will investigate the outcomes. The patient will be not informed of the infusion of nefopam by not attaching an identifiable label so that it cannot be distinguished from normal saline.
Intervention model description
A prospective randomized double-blinded study
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia * American Society of Anesthesiologists (ASA) physical classification I-II * Consent to IV-patient controlled analgesia use * Willingness and ability to sign an informed consent document
Exclusion criteria
* Do not understand our study * Allergies to anesthetic or analgesic medications * Continuous local anesthetics infiltration for postoperative pain control * Patients who receive mechanical ventilation more than 2 hours after surgery * Pregnancy/Breast feeder * Medical or psychological disease that can affect the treatment response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fentanyl consumption during 24 hours | postoperative 24 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total fentanyl consumption | postoperative 48 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia |
| Postoperative pain score | postoperative 24, 48 hours | 11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, no pain; 10, worst pain imaginable |
| Postoperative nausea and vomiting | postoperative 24, 48 hours | Incidence of postoperative nausea and vomiting (%) |
| chronic postsurgical pain | 3-months after surgery | Incidence of chronic postsurgical pain (NRS ≥ 3) (%) |
Countries
South Korea
Outcome results
None listed