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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2020-10-30

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.

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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.

Conditions

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Total Laparoscopic Hysterectomy Patient-controlled Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1-channel PCA

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)

Group Type ACTIVE_COMPARATOR

convetional PCA method unsing only 1-channel

Intervention Type OTHER

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)

2-channel PCA

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)

Group Type EXPERIMENTAL

utilizing 2-channel

Intervention Type OTHER

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)

Interventions

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convetional 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)

Intervention Type OTHER

utilizing 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)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No