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

Korea University

Status: Completed

Conditions: Patient-controlled Analgesia; Total Laparoscopic Hysterectomy

Treatments: Other: utilizing 2-channel; Other: convetional PCA method unsing only 1-channel

Study type: Interventional

Funder types: Other

Identifiers

NCT04082039

2019GR0294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

1-channel PCA

Active Comparator group

Description:

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)

Treatment:

Other: convetional PCA method unsing only 1-channel

2-channel PCA

Experimental group

Description:

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)

Treatment:

Other: utilizing 2-channel