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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
Sponsor:
Information provided by (Responsible Party):
Hung-Chang Chen, China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Naldebain Drug: Morpine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NALDEBAIN
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
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.
Drug: Morpine
In Morphine group, patients will receive morphine as needed after surgery.




Primary Outcome Measures :
  1. Supplemental analgesics [ Time Frame: From Day 0 to Day 7 ]
    The consumption of total amount (mg) of supplemental analgesics administered after surgery.


Secondary Outcome Measures :
  1. Pain assessment: VAS [ Time Frame: 2 hours after surgery ]
    Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

  2. Pain assessment: VAS [ Time Frame: 6 hours after surgery ]
    Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

  3. Pain assessment: VAS [ Time Frame: 24 hours after surgery ]
    Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

  4. 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

  5. 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

  6. Patient satisfaction: frequency of each option [ Time Frame: Day 7 ]
    Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied

  7. frequency of adverse event [ Time Frame: From Day-1 to Day 7 ]
    Recording the frequency of treatment-emergent adverse event (TEAE)


Other Outcome Measures:
  1. Time of first farting [ Time Frame: From post-OP to Day 7 ]
    Observing when patients are able to pass gas after surgery

  2. Date of discharge [ Time Frame: From post-OP to Day 7 ]
    Observing when the condition of patients is good enough to discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Hung-Chang Chen 04-22052121 ext 81-221071 D96591@mail.cmuh.org.tw

Locations
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Taiwan
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         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Hung-Chang Chen, MD China Medical University Hospital

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Responsible Party: Hung-Chang Chen, Director of Minimally Invasive Centre, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03854851    
Other Study ID Numbers: CMUH107-REC2-110
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hung-Chang Chen, China Medical University Hospital:
Naldebain
long-term analgesia
take down of anastomosis
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents