Interaction Between Nalbuphine and Morphine in PCA

Back to results

Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Nalbuphine and morphine

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring analgeisa, postoperatve, side effects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age 18-65 y/o Female patients of ASA physical status I to III Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor Exclusion Criteria: Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants) Intraoperative fentanyl use > 3 μg/kg Patients with definite diagnosis of esophageal reflux syndrome Use of sedatives, antiemetics, or antipruritics within 24 hours before operation Surgery > 4 hours or laparoscopy surgery

Sites / Locations

National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

analgesic effect

Secondary Outcome Measures

incidence of opioid-related side effects

Full Information

NCT ID

NCT00155233

First Posted

September 8, 2005

Last Updated

November 22, 2005

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00155233

Brief Title

Interaction Between Nalbuphine and Morphine in PCA

Official Title

Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist This study was designed to investigate the interaction between nalbuphine and morphine

Detailed Description

Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist This study was designed to investigate the interaction between nalbuphine and morphine The analgesic effect and opioid-related side effects will be investigated

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

analgeisa, postoperatve, side effects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nalbuphine and morphine

Primary Outcome Measure Information:

Title

analgesic effect

Secondary Outcome Measure Information:

Title

incidence of opioid-related side effects

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age 18-65 y/o Female patients of ASA physical status I to III Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor Exclusion Criteria: Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants) Intraoperative fentanyl use > 3 μg/kg Patients with definite diagnosis of esophageal reflux syndrome Use of sedatives, antiemetics, or antipruritics within 24 hours before operation Surgery > 4 hours or laparoscopy surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-Zen Sun, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu Chang Yeh, MD

Email

cooltony@ha.mc.ntu.edu.tw

First Name & Middle Initial & Last Name & Degree

Wei-Zen Sun, MD

Postoperative Pain

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial