Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00824772
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative

Detailed Description

The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.

Study Design

• Study Type: Observational
• Actual Enrollment: 204 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. Postoperative Cumulative Fentanyl Consumption [24 hr after surgery]

Secondary Outcome Measures

1. Postoperative Cumulative Fentanyl Consumption [48hr after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia

• Patients who want to use intravenous patient controlled analgesia (PCA) after surgery

• ASA physical status class I, II

Exclusion Criteria:

• history of drug addiction

• opioid medication within 12 hours before surgery

• previous history of opioid medication for 3 months

• neurologic disorder

• cardiac disorder

• hepatic disease

• renal disease

• respiratory disease such as COPD, asthma

• sleep apnea

• BMI > 30

• psycotic disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Sanggye Paik Hospital	Seoul		Korea, Republic of	139-707

Sponsors and Collaborators

• Inje University

Investigators

• Principal Investigator: Kye-Min Kim, MD. PhD., Department of Anesthesia, Inje University Sanggye Paik Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kye-Min Kim, Associate professor, Department of Anesthesiolgy & Pain Medicine, Inje University, Inje University
• ClinicalTrials.gov Identifier: NCT00824772
• Other Study ID Numbers: 00012007317-00
• First Posted: Jan 19, 2009
• Last Update Posted: Jun 4, 2013
• Last Verified: May 1, 2013

• Keywords provided by Kye-Min Kim, Associate professor, Department of Anesthesiolgy & Pain Medicine, Inje University, Inje University: pharmacogenetics
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Recruitment Details	Dates of recruitment: 2008 Sep - 2010 Feb Type of location: university hospital
Pre-assignment Detail	No group assignment required for this study.

Arm/Group Title	Gynecologic Patients Undergoing TAH, LAVH
Arm/Group Description	Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Period Title: Overall Study
STARTED	204
COMPLETED	196
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Gynecologic Patients Undergoing TAH, LAVH
Arm/Group Description	Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Overall Participants	204
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	204 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.3 (4.9)
Sex: Female, Male (Count of Participants)
Female	204 100%
Male	0 0%
Region of Enrollment (participants) [Number]
Korea, Republic of	204 100%

Outcome Measures

1. Primary Outcome

Title	Postoperative Cumulative Fentanyl Consumption
Time Frame	24 hr after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gynecologic Patients Undergoing TAH, LAVH
Arm/Group Description	Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Measure Participants	196
Mean (Standard Deviation) [mcg]	836 (416)

2. Secondary Outcome

Title	Postoperative Cumulative Fentanyl Consumption
Time Frame	48hr after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gynecologic Patients Undergoing TAH, LAVH
Arm/Group Description	Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Measure Participants	196
Mean (Standard Deviation) [mcg]	1028 (520)

Adverse Events

Arm/Group Title	Gynecologic Patients Undergoing TAH, LAVH
Arm/Group Description	Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
All Cause Mortality
	Gynecologic Patients Undergoing TAH, LAVH
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Gynecologic Patients Undergoing TAH, LAVH
	Affected / at Risk (%)	# Events
Total	0/204 (0%)
Other (Not Including Serious) Adverse Events
	Gynecologic Patients Undergoing TAH, LAVH
	Affected / at Risk (%)	# Events
Total	0/204 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.