NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

• Status: Unknown status
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Treatments: Morphine

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