NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Naldebain; Drug: Morpine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University & Hospital
    • Contact: Hung-Chang Chen; Phone Number: 81-221071 04-22052121; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplemental analgesics	The consumption of total amount (mg) of supplemental analgesics administered after surgery.	From Day 0 to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	2 hours after surgery
Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	6 hours after surgery
Pain assessment: VAS	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)	24 hours after surgery
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
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
Patient satisfaction: frequency of each option	Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied	Day 7
frequency of adverse event	Recording the frequency of treatment-emergent adverse event (TEAE)	From Day-1 to Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first farting	Observing when patients are able to pass gas after surgery	From post-OP to Day 7
Date of discharge	Observing when the condition of patients is good enough to discharge	From post-OP to Day 7

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Hung-Chang Chen, MD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2019
• Study Completion (ANTICIPATED): October 31, 2019

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Naldebain; long-term analgesia; take down of anastomosis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CMUH107-REC2-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No