An interventional study of group A and group B in Post Operative Pain and Opioid Side Effects, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment
This study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. The investigators will randomize patients into three groups to compare the analgesia effects and side effects.
Nalbuphine is a FDA approved noncontrolled drug of opioid. And it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine.
However, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. If the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid.
The investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. If the pain or side effects of opioid were intolerable, the investigators will change pain medications into NSAIDs or other adequate medications to comfort the patient.
The primary outcome were numerical rating pain score and consumption of nalbuphine. The secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 150 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
mutonpain 0.05 mg/kg
Drug: group A
mutonpain 0.1 mg/kg
Drug: group B
mutonpain 0.2 mg/kg
Drug: group C
mutonpain 0.05 mg/kg
mutonpain 0.1 mg/kg
mutonpain 0.2 mg/kg
Numerical Rating Pain Scale
The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The investors will measure the pain score at rest state and upon movement state at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours.
Time frame: numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
consumption of nalbuphine
The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.
Time frame: Record the opioid dose changes 2 days.
nausea
we will go to bed side and have an self-report episode of nausea at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
Time frame: the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
vomiting
we will go to bed side and have an self-report episode of vomiting at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation
Time frame: the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
satisfactory score by net promoter score
The net promoter score is a subjective measure in which individuals rate their satisfactory on an ten-point numerical scale. The scale is composed of 1 to 10. We will measure the net promoter score at the end of the study
Time frame: 2 days
use of rescue pain medications
if the patient use other pain medication on request of poor pain control or poor tolerant of the side effects of nalbuphine
Time frame: record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
use of antiemetics
if the patient use of antiemetics during the hospitalization
Time frame: 2 days
use of antipruritics
if the patient use of antipruritics during the hospitalization
Time frame: 2 days
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Kaohsiung Medical University Chung-Ho Memorial Hospital