Clinical trial NCT04082039: Two-channel Intravenous Patient-controlled Analgesia (IV-PCA) After Total Laparoscopic Hysterectomy (TLH)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Laparoscopic Hysterectomy
Patient-controlled Analgesia
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Korean version of the Quality of Recovery-40 questionnaire (QoR-40K) score
timeFrame: At postoperative 24 hour
Secondary outcomes:
measure: Pain level was evaluated according to a numeric rating scale
timeFrame: At 6, 12, 24, 36, 48 hours after surgery
measure: Cumulative consumption of PCA over 48 hours
timeFrame: At postoperative 48 hour
measure: The patient's overall satisfaction score
timeFrame: At postoperative 48 hour
measure: Occurrence of adverse effects
timeFrame: Participants will be followed for their entire hospital stay, an expected average of 3-4 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital
Study officials:
References:
citation: 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.