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

NCT04082039 | Completed DMC

• 1 other identifier: 2019GR0294
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Laparoscopic Hysterectomy; Patient-controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain level was evaluated according to a numeric rating scale

  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

  At postoperative 48 hour

• Occurrence of adverse effects

  Participants will be followed for their entire hospital stay, an expected average of 3-4 days

Study Arms (2)

1-channel PCA

ACTIVE COMPARATOR

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

2-channel PCA

EXPERIMENTAL

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

Interventions

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)

1-channel PCA

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)

2-channel PCA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36224646 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: September 3, 2019
• Primary Completion: August 10, 2020
• Study Completion: October 30, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)