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

Patient-controlled Analgesia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082039
• Other study ID #: 2019GR0294
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 30, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient-controlled Analgesia
• Total Laparoscopic Hysterectomy

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cumulative consumption of PCA over 48 hours		At postoperative 48 hour
Secondary	The patient's overall satisfaction score	(0-10; 0 = un-satisfied to 10 = full-satisfied)	At postoperative 48 hour
Secondary	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