Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04808544 |
| Other study ID # |
EMRP28110N |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2021 |
| Est. completion date |
April 18, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
E-DA Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Laparoscopic cholecystectomy is the most common surgical procedure for removal of the
inflamed gall bladder or other gall bladder pathologies. There are more than 12,000 cases of
cholecystectomy performed in Taiwan annually, and more than 85% of this procedure are
undertook with laparoscopic techniques. Even with minimally invasive laparoscopic operation,
patients may still suffer from postoperative wound pain, deep visceral or referred pain.
About 80% of patients who received laparoscopic procedures complain of moderate-to-severe
pain within the first day after cholecystectomy. Most importantly, up to 20% (range from 3 to
20%) of these patients complained surgical-related pain one year after operation and they
require prolonged use of opioid to control chronic postoperative pain (CPSP). However, there
are currently lack of clinical practice guidelines or recommendations for prevention of CPSP
after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block
or intrathecal opioid) are considered as effective supplementary analgesic approaches to
improve postoperative pain control, parenteral administration of analgesics remain as the
mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of
nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release
dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release
nalbuphine. A number of clinical studies have shown that single-dose of pre-operative
intramuscular administration of Naldebain® provides significantly higher analgesic effect up
to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile.
Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to
investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in
patients receiving laparoscopic cholecystectomy, and prevention of the development of CPSP
after surgery.
Description:
Clinical studies indicate that more than 80% of patients suffer from surgical-related pain in
the first few days after major laparotomy or laparoscopic abdominal surgery and about 10% of
these patients may develop chronic postoperative pain (CPSP), which can last up to several
years after surgery. One of the major risk factors for developing CPSP is inadequate
management of the acute postoperative pain. Laparoscopic cholecystectomy is the most common
surgical procedure for removal of the inflamed gall bladder or other gall bladder
pathologies. There are more than 12,000 cases of cholecystectomy performed in Taiwan
annually, and more than 85% of this procedure are undertook with laparoscopic techniques.
Even with the minimally invasive laparoscopic operation, patients may still suffer from acute
postoperative surgical-related pain. About 80% of patients who received laparoscopic
procedures complain of moderate-to-severe pain within the first day after cholecystectomy.
Most importantly, up to 20% (range from 3 to 20%) of these patients complained
surgical-related pain one year after operation and they require prolonged use of opioid to
control CPSP. The proposed mechanisms of CPSP after laparoscopic cholecystectomy include
somatic component (incisional wound pain), visceral component (deep abdominal pain) and
referred pain component (shoulder pain). Several important clinical observational studies
suggested that inadequate management of surgical-related pain within one week after
cholecystectomy is one of the major risk factors for developing CPSP. In addition to
pain-related complications, CPSP may also impair patient's quality of life after surgery.
However, there are currently lack of clinical practice guidelines or recommendations for
prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques
(i.e. truncal block or intrathecal opioid) are considered as effective supplementary
analgesic approaches to improve postoperative pain control, parenteral administration of
analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery.
Nalbuphine is a semi-synthetic opioid that acts as a mixed kappa opioid agonist and mu opioid
antagonist, but its clinical applications in relieving acute postoperative pain is limited by
the relatively short duration of action of 3-6h. Naldebain® is prodrug of nalbuphine, which
was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine
sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A
number of clinical studies have shown that single-dose of pre-operative intramuscular
administration of Naldebain® provides significantly higher analgesic effect up to 1 week in
hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Naldebain® has
not been tested in laparoscopic surgery. Therefore, this PI-initiated randomized,
double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain®
in management of acute postoperative pain in patients receiving laparoscopic cholecystectomy,
and prevention of the development of CPSP after surgery.
