Postoperative Pain
Conditions
Keywords
Naldebain, long-term analgesia, take down of anastomosis
Brief 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.
Detailed description
This is an open-labeled, randomized clinical trial. After ICFs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. And then, on Day -1, eligible ones will randomly be divide into two separate group: NALDEBAIN or MORPHINE. Group NALDEBAIN will receive Nadebain by gluteus maximus injection between 12 and 24 hours prior to surgery for postoperative pain relief. Group MORPHINE will receive morphine as needed after surgery. All necessary data will be gain form EMR or patient dairies.
Interventions
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Men and Women between 20 and 80 years of age 2. History of laparoscopic surgery 3. American Society of Anesthesiology Physical Class 1-3 4. Ability and willingness to provide informed consent
Exclusion criteria
1. History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen 2. Chronic preoperative opioid use 3. Severe comorbidity which is able to interfere pain assessment 4. Ostomy surgery of intestine within the past 8 weeks 5. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Supplemental analgesics | From Day 0 to Day 7 | The consumption of total amount (mg) of supplemental analgesics administered after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment: VAS | 2 hours after surgery | Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain) |
| Pain assessment: area under the curve of VAS | 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 | Day 7 | Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied |
| frequency of adverse event | From Day-1 to Day 7 | Recording the frequency of treatment-emergent adverse event (TEAE) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time of first farting | From post-OP to Day 7 | Observing when patients are able to pass gas after surgery |
| Date of discharge | From post-OP to Day 7 | Observing when the condition of patients is good enough to discharge |
Countries
Taiwan
Contacts
Primary ContactHung-Chang Chen
Outcome results
None listed