Patient-controlled Analgesia, Total Laparoscopic Hysterectomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERconvetional PCA method unsing only 1-channel
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)
OTHERutilizing 2-channel
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)
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patient who was scheduled to undergo elective TLH under general anesthesia, was a female aged 19-75 years, and had an American Society of Anesthesiologists physical status I-II
Exclusion criteria
* body mass index \> 30.0 kg/m2, known hypersensitivity to the drugs used in this study, significant liver or renal dysfunction, or a history of drug abuse or dependence, recent major procedure or surgery, or preoperative analgesic use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score | At postoperative 24 hour | Patient recovery measured by QoR-40K score (maximum score 200) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level was evaluated according to a numeric rating scale | At 6, 12, 24, 36, 48 hours after surgery | (NRS; 0-100; no pain \[0\] to worst pain imaginable \[100\]) |
| Cumulative consumption of PCA over 48 hours | At postoperative 48 hour | — |
| The patient's overall satisfaction score | At postoperative 48 hour | (0-10; 0 = un-satisfied to 10 = full-satisfied) |
| Occurrence of adverse effects | Participants will be followed for their entire hospital stay, an expected average of 3-4 days | nausea and vomiting, dry mouth, dizziness, urinary retention, headache, sedation, itchiness, shivering, respiratory depression, confusion, hypotension, and bradycardia |
Countries
South Korea
Outcome results
None listed