The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery

NCT03296488 | Unknown Phase 4 DMC

• 1 other identifier: KMUHIRB-F(I)-20170089
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.

Conditions

Pain, Postoperative

Keywords

post-laparotomy wound pain; NALDEBAIN (150 mg Nalbuphine Sebacate); PCA (patient-control-ed alagesia)

Outcome Measures

Primary Outcomes (1)

• pain assessment (post-OP 48 hours)

  Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery.

  During post-OP 48 hours

Secondary Outcomes (5)

• supplemental analgesics

  From post-OP to Day 6

• Pain assessment (post-OP to Day 6)

  From post-OP to Day 6

• Brief Pain Inventory

  pre-OP Day -1, post-OP Day 2 and Day 6

• Patient satisfaction

  On discharge Day, between post-OP Day 7 and Day 14

• Length of postoperative hospital stay

  From post-OP to Discharge Day, about 1 to 2 weeks

Other Outcomes (2)

• Adverse event

  From post-OP Day 1 to Discharge Day, about 1 to 2 weeks

• other abnormalities

  From Screening Day to Discharge Day, about 1 to 2 weeks

Study Arms (2)

Nalbuphine Sebacate

EXPERIMENTAL

receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery.

Drug: Nalbuphine Sebacate

Fentanyl Citrate

ACTIVE COMPARATOR

receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.

Drug: Fentanyl Citrate

Interventions

Nalbuphine Sebacate DRUG

intramuscular single dose of NALDEBAIN 24±12 hours before surgery.

Also known as: NALDEBAIN

Nalbuphine Sebacate

Fentanyl Citrate DRUG

Intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.

Also known as: PCA with fentanyl

Fentanyl Citrate

Eligibility Criteria

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

You may qualify if:

• Male or female who is among 20 to 80 years of age at screening.
• Scheduled to electively undergo open-laparotomy.
• American Society of Anesthesiology Physical Class 1-3.
• Ability and willingness to provide informed consent

You may not qualify if:

• Body mass index less than 18 kg/m2 or greater than 30 kg/m2.
• History of previous open-laparotomy.
• Surgery with major complication, or need blood transfusion.
• History of hypersensitivity or adverse reaction to local anesthetics, opioid, or any ingredient of the medications administered in this study.
• Severe comorbidity.
• Chronic preoperative opioid consumption.
• Pregnant or breastfeeding.
• Inability to use the PCA device.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

RECRUITING

Related Publications (2)

• Chang TK, Huang CW, Su WC, Tsai HL, Ma CJ, Yeh YS, Chen YC, Li CC, Cheng KI, Su MP, Wang JY. Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial. Pain Ther. 2020 Dec;9(2):671-681. doi: 10.1007/s40122-020-00197-x. Epub 2020 Sep 29.

  PMID: 32990938 DERIVED

• Tsai HL, Chang TK, Su WC, Yeh YS, Huang CW, Ma CJ, Wang JY. Comparing efficacy and safety between Naldebain(R) and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial. Trials. 2019 Mar 18;20(1):173. doi: 10.1186/s13063-019-3260-4.

  PMID: 30885242 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Jaw-Yuan Wang, PhD

  Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

  STUDY CHAIR

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: Professor

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 28, 2017
• Study Start: August 17, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)