The purpose of this study is to compare the dual channel intravenous patient-controlled analgesia (IV-PCA) with single channel elastomeric pump (only one channel of dual channel pump is used for blinding and the other channel is filled with same volume of saline) in patients undergoing total laparoscopic hysterectomy, in terms of quality of recovery, efficacy of postoperative pain, drug consumption, adverse event, and patient subjective satisfaction.
The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si, Gyeonggi-do, Republic of Korea) is a newly designed IV-PCA device that is a 2-channel infusion elastomeric pump with two balloon chambers. Conventional elastomeric IV-PCA devices were administered with a mixture of drugs in one chamber; when severe opioid related side effects occur, the IV-PCA administration is suspended by clipping, in this situation, not only the analgesic effect of opioid but also the effect of adjuvants could not be applied. On the other hand, this newly designed device can be controlled as needed by administering adjuvant analgesics or antiemetic agents through another adjustable chamber. It will be expected that facilitate the pain management and increased the patient satisfaction and recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
90
Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg, ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline); Ch-2 (flow 2ml/h): 100ml normal saline only (for blinding)
Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg (total volume 100 ml with normal saline; Ch-2 (flow 2ml/h fixed): ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline)
Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital
Seoul, South Korea
Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score
Patient recovery measured by QoR-40K score (maximum score 200)
Time frame: At postoperative 24 hour
Pain level was evaluated according to a numeric rating scale
(NRS; 0-100; no pain \[0\] to worst pain imaginable \[100\])
Time frame: At 6, 12, 24, 36, 48 hours after surgery
Cumulative consumption of PCA over 48 hours
Time frame: At postoperative 48 hour
The patient's overall satisfaction score
(0-10; 0 = un-satisfied to 10 = full-satisfied)
Time frame: At postoperative 48 hour
Occurrence of adverse effects
nausea and vomiting, dry mouth, dizziness, urinary retention, headache, sedation, itchiness, shivering, respiratory depression, confusion, hypotension, and bradycardia
Time frame: Participants will be followed for their entire hospital stay, an expected average of 3-4 days
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