Two-channel Intravenous Patient-controlled Analgesia (IV-PCA) After Total Laparoscopic Hysterectomy (TLH)

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of New Design Dual Channel Elastomeric Pump for Intravenous Patient-controlled Analgesia After Total Laparoscopic Hysterectomy: a Randomized, Double-blind, Prospective Study

Conditions
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Total Laparoscopic Hysterectomy, Patient-controlled Analgesia

Intervention / Treatment
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* Other: convetional PCA method unsing only 1-channel
* Other: utilizing 2-channel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-channel PCA<br>Ch-1: fentanyl 16 µg/kg, ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline) Ch-2: 100ml normal saline only (for blinding) | Other: convetional PCA method unsing only 1-channel<br>* 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)<br>|
| Experimental: 2-channel PCA<br>Ch-1: fentanyl 16 µg/kg (total volume 100 ml with normal saline) Ch-2: ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline) | Other: utilizing 2-channel<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score | Patient recovery measured by QoR-40K score (maximum score 200) | At postoperative 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level was evaluated according to a numeric rating scale | (NRS; 0-100; no pain [0] to worst pain imaginable [100]) | At 6, 12, 24, 36, 48 hours after surgery | 
| Cumulative consumption of PCA over 48 hours |  | At postoperative 48 hour | 
| The patient's overall satisfaction score | (0-10; 0 = un-satisfied to 10 = full-satisfied) | 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 | Participants will be followed for their entire hospital stay, an expected average of 3-4 days |