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

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

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.

Study Overview

• Status: Completed
• Conditions: Total Laparoscopic Hysterectomy; Patient-controlled Analgesia
• Intervention / Treatment: Other: convetional PCA method unsing only 1-channel; Other: utilizing 2-channel

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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)
Experimental: 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)	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital

Publications and helpful links

General Publications

• Oh SK, Kim H, Kim YS, Lee CH, Oh JS, Kwon DH. The effect of newly designed dual-channel elastomeric pump for intravenous patient-controlled analgesia after total laparoscopic hysterectomy: a randomized, double-blind, prospective study. Perioper Med (Lond). 2022 Oct 12;11(1):52. doi: 10.1186/s13741-022-00282-z.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 2019GR0294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: In order to protect patient priavacy and personal information, we will limit the provision of individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No