NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

NCT03854851 | Unknown Phase 4

• 1 other identifier: CMUH107-REC2-110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Naldebain; long-term analgesia; take down of anastomosis

Outcome Measures

Primary Outcomes (1)

• Supplemental analgesics

  The consumption of total amount (mg) of supplemental analgesics administered after surgery.

  From Day 0 to Day 7

Secondary Outcomes (7)

• Pain assessment: VAS

  2 hours after surgery

• Pain assessment: VAS

  6 hours after surgery

• Pain assessment: VAS

  24 hours after surgery

• Pain assessment: VAS

  From Day 2 to Day 7

• Pain assessment: area under the curve of VAS

  From post-OP to Day 7

Other Outcomes (2)

• Time of first farting

  From post-OP to Day 7

• Date of discharge

  From post-OP to Day 7

Study Arms (2)

NALDEBAIN

EXPERIMENTAL

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.

Drug: Naldebain

MORPHINE

ACTIVE COMPARATOR

In group MORPHINE, subjects will receive morphine as needed after surgery.

Drug: Morpine

Interventions

Naldebain DRUG

In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.

NALDEBAIN

Morpine DRUG

In Morphine group, patients will receive morphine as needed after surgery.

MORPHINE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women between 20 and 80 years of age
• History of laparoscopic surgery
• American Society of Anesthesiology Physical Class 1-3
• Ability and willingness to provide informed consent

You may not qualify if:

• History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen
• Chronic preoperative opioid use
• Severe comorbidity which is able to interfere pain assessment
• Ostomy surgery of intestine within the past 8 weeks
• Pregnant or breastfeeding

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University & Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hung-Chang Chen, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chang Chen

CONTACT

04-22052121; D96591@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Minimally Invasive Centre

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: March 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)