NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis

NCT ID: NCT03854851

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-10-31

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Naldebain

Intervention Type: DRUG

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

MORPHINE

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

Group Type: ACTIVE_COMPARATOR

Morpine

Intervention Type: DRUG

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

Interventions

Naldebain

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

Intervention Type: DRUG

Morpine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hung-Chang Chen

Director of Minimally Invasive Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hung-Chang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University & Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Chang Chen

Role: CONTACT

D96591@mail.cmuh.org.tw

04-22052121 ext. 81-221071

Facility Contacts

Hung-Chang Chen

Role: primary

D96591@mail.cmuh.org.tw

04-22052121 ext. 81-221071

Other Identifiers

CMUH107-REC2-110

Identifier Type: -

Identifier Source: org_study_id