NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

Postoperative Pain Clinical Trial

Official title:

NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03854851
• Other study ID #: CMUH107-REC2-110
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2019
• Source: China Medical University Hospital
• Contact: Hung-Chang Chen
• Phone: 04-22052121
• Email: D96591[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University & Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of first farting	Observing when patients are able to pass gas after surgery	From post-OP to Day 7
Other	Date of discharge	Observing when the condition of patients is good enough to discharge	From post-OP to Day 7
Primary	Supplemental analgesics	The consumption of total amount (mg) of supplemental analgesics administered after surgery.	From Day 0 to Day 7
Secondary	Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	2 hours after surgery
Secondary	Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	6 hours after surgery
Secondary	Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	24 hours after surgery
Secondary	Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain), once daily	From Day 2 to Day 7
Secondary	Pain assessment: area under the curve of VAS	Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 7 days after surgery	From post-OP to Day 7
Secondary	Patient satisfaction: frequency of each option	Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied	Day 7
Secondary	frequency of adverse event	Recording the frequency of treatment-emergent adverse event (TEAE)	From Day-1 to Day 7