Postoperative Pain
Conditions
Keywords
Postoperative Pain
Brief summary
This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.
Detailed description
Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. The control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.
Interventions
Intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (total 100 ml)
DRUGSaline
100 ml of normal saline
Sponsors
Kyongbo Pharmaceutical
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The nurse who is not involved in this study knows the allocated group and sends the bottle of the drug which looks the same in both groups, to the operation room and ward. The care provider, investigator, patients, and outcomes assessor will be not informed of the infusion of the drug 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 80 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/Breastfeeder * Medical or psychological disease that can affect thetreatment 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 6, 48 hours | postoperative fentanyl consumption (mcg) via IV patient controlled analgesia |
| Postoperative pain score | postoperative 6, 24, 48 hours | 11-pointed NRS pain score at resting/coughing NRS (0-10): 0,no pain; 10, worst pain imaginable |
| Postoperative nausea and vomiting | postoperative 24, 48 hours | Incidence of postoperative nausea and vomiting (%) |
| Quality of recovery-15 | postoperative 24, 48 hours | Korean version of Quality of recovery-15 questionnaire (0-150): 0, very poor recovery; 150, excellent recovery |
Countries
South Korea
Outcome results
None listed