NCT04082039

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Laparoscopic Hysterectomy
• Patient-controlled Analgesia

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2019-09-03
• Primary completion: 2020-08-10
• Completion: 2020-10-30
• First posted: 2019-09-09
• Last updated: 2021-02-18

Locations

1 site across 1 country: South Korea