NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
Status:
Unknown status
Trial end date:
2019-10-31
Target enrollment:
Participant gender:
Summary
NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic
prodrug with oil-based solution to extend the release in human body by intramuscular
injection. It was approved for the premedication use for moderate to severe pain relief,
expected after surgery. There was limited experience with the combination of medication and
different type of surgeries. Only the effect of operative analgesia on the hemorrhoidectomy
patients have been well studied. Through reviewing the past medical cases, the pain intensity
after receiving take down of anastomosis was about 4 to 7 points (moderate pain), lasing
about 1 to 3 days. It was a suitable population with multi-day analgesic unmet need.
At present, the standard treatment after take down of anastomosis in the CMUH was morphine as
needed. This treatment might not provide for well-controlled postoperative pain management.
Patients might receive more painkillers when they needed than before pain occurred. Plus, it
also cost more postoperative medical care. Therefore, this study intended to compare the
standard treatment and NALDEBAIN for postoperative outcomes, safety and satisfaction.
The study will enroll patients scheduled to electively undergo take down of anastomosis.
Eligible subjects were randomly divided into two groups, one receiving NALDEBAIN and the
other receiving standard treatment. The study will evaluate pain intensity, dosage of
supplement analgesics, incidence of adverse reactions, patient satisfaction, time of the
first fart after surgery, and duration of postoperative hospital stay.