NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
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|ClinicalTrials.gov Identifier: NCT03854851|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Naldebain Drug: Morpine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
In group NALDEBAIN, subjects will receive single dose of Naldebain (150 mg/2 ml) by gluteus maximus injection between 12 and 24 hours prior to surgery.
In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.
Active Comparator: MORPHINE
In group MORPHINE, subjects will receive morphine as needed after surgery.
In Morphine group, patients will receive morphine as needed after surgery.
- Supplemental analgesics [ Time Frame: From Day 0 to Day 7 ]The consumption of total amount (mg) of supplemental analgesics administered after surgery.
- Pain assessment: VAS [ Time Frame: 2 hours after surgery ]Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
- Pain assessment: VAS [ Time Frame: 6 hours after surgery ]Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
- Pain assessment: VAS [ Time Frame: 24 hours after surgery ]Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
- Pain assessment: VAS [ Time Frame: From Day 2 to Day 7 ]Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain), once daily
- Pain assessment: area under the curve of VAS [ Time Frame: From post-OP to Day 7 ]Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 7 days after surgery
- Patient satisfaction: frequency of each option [ Time Frame: Day 7 ]Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied
- frequency of adverse event [ Time Frame: From Day-1 to Day 7 ]Recording the frequency of treatment-emergent adverse event (TEAE)
- Time of first farting [ Time Frame: From post-OP to Day 7 ]Observing when patients are able to pass gas after surgery
- Date of discharge [ Time Frame: From post-OP to Day 7 ]Observing when the condition of patients is good enough to discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854851
|Contact: Hung-Chang Chen||04-22052121 ext 81-221071||D96591@mail.cmuh.org.tw|
|China Medical University & Hospital||Recruiting|
|Taichung, Taiwan, 404|
|Contact: Hung-Chang Chen 04-22052121 ext 81-221071 D96591@mail.cmuh.org.tw|
|Principal Investigator: Hung-Chang Chen|
|Sub-Investigator: Tzu-Liang Chen|
|Sub-Investigator: Hwei-Ming Wang|
|Sub-Investigator: Tao-Wei Ke|
|Sub-Investigator: Hua-Che Chiang|
|Sub-Investigator: Sheng-Chi Chang|
|Sub-Investigator: Yu-Chuen Huang|
|Sub-Investigator: Yi-Chang Chen|
|Sub-Investigator: Ming-Hao Hsieh|
|Sub-Investigator: Yuan-Yao Tsai|
|Principal Investigator:||Hung-Chang Chen, MD||China Medical University Hospital|