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

Not Applicable

Completed

• Conditions: Total Laparoscopic Hysterectomy; Patient-controlled Analgesia
• Interventions: Other: utilizing 2-channel; Other: convetional PCA method unsing only 1-channel

• Registration Number: NCT04082039
• Lead Sponsor: Korea University Guro Hospital

Brief 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.

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 Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Primary Completion: 2020-08-10
• Study Completion: 2020-10-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-channel PCA	utilizing 2-channel	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)
1-channel PCA	convetional PCA method unsing only 1-channel	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)

Primary Outcome Measures

Name	Time	Method
Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score	At postoperative 24 hour	Patient recovery measured by QoR-40K score (maximum score 200)

Secondary Outcome Measures

Name	Time	Method
The patient's overall satisfaction score	At postoperative 48 hour	(0-10; 0 = un-satisfied to 10 = full-satisfied)
Cumulative consumption of PCA over 48 hours	At postoperative 48 hour
Occurrence of adverse effects	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
Pain level was evaluated according to a numeric rating scale	At 6, 12, 24, 36, 48 hours after surgery	(NRS; 0-100; no pain \[0\] to worst pain imaginable \[100\])

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of