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Completed

NCT Number: NCT04082039

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

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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Key information

Conditions

Total Laparoscopic Hysterectomy Patient-Controlled Analgesia

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Seoul, 08308, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

convetional PCA method unsing only 1-channel

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)

utilizing 2-channel

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)

Primary outcomes

  1. Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score

    Time frame: At postoperative 24 hour

    Patient recovery measured by QoR-40K score (maximum score 200)

Secondary outcomes

  1. Pain level was evaluated according to a numeric rating scale

    Time frame: At 6, 12, 24, 36, 48 hours after surgery

    (NRS; 0-100; no pain [0] to worst pain imaginable [100])

  2. Cumulative consumption of PCA over 48 hours

    Time frame: At postoperative 48 hour

  3. The patient's overall satisfaction score

    Time frame: At postoperative 48 hour

    (0-10; 0 = un-satisfied to 10 = full-satisfied)

  4. Occurrence of adverse effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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