Clinical trial NCT03854851: NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
Official title: NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Naldebain
long-term analgesia
take down of anastomosis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Supplemental analgesics
timeFrame: From Day 0 to Day 7
Secondary outcomes:
measure: Pain assessment: VAS
timeFrame: 2 hours after surgery
measure: Pain assessment: VAS
timeFrame: 6 hours after surgery
measure: Pain assessment: VAS
timeFrame: 24 hours after surgery
measure: Pain assessment: VAS
timeFrame: From Day 2 to Day 7
measure: Pain assessment: area under the curve of VAS
timeFrame: From post-OP to Day 7
measure: Patient satisfaction: frequency of each option
timeFrame: Day 7
measure: frequency of adverse event
timeFrame: From Day-1 to Day 7
Other outcomes:
measure: Time of first farting
timeFrame: From post-OP to Day 7
measure: Date of discharge
timeFrame: From post-OP to Day 7
Locations:
city: Taichung
country: Taiwan
facility: China Medical University & Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hung-Chang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: