MedTrace Logo

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

NCT04082039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

  • Total Laparoscopic Hysterectomy
  • Patient-controlled Analgesia

Interventions

OTHER

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)

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)

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2020-08-10
Completion
2020-10-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082039 on ClinicalTrials.gov