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Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier:
NCT00418015
First received: December 31, 2006
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: February 15, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Labor Pain
Post-cesarean Delivery
Intervention: Procedure: Blood Draw

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Laboring subject recruited from 10/2005 to 9/2006 Post cesarean delivery subjects recruited from 10/2005 to 5/2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded from the labor analgesia group if they had received an opioid analgesic before initiation of intrathecal analgesia or if they received neuraxial analgesia before 2cm of cervical dilation.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Participant Flow:   Overall Study
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
STARTED     144     46     78     25  
COMPLETED     144     46     78     25  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
Total Total of all reporting groups

Baseline Measures
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G     Total  
Number of Participants  
[units: participants]
  144     46     78     25     293  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     144     46     78     25     293  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Median ( Inter-Quartile Range )
  30  
  ( 28 to 34 )  
  32  
  ( 30 to 34 )  
  34  
  ( 31 to 37 )  
  32  
  ( 29 to 35 )  
  32  
  ( 28 to 34 )  
Gender  
[units: participants]
         
Female     144     46     78     25     293  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     144     46     78     25     293  



  Outcome Measures
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1.  Primary:   Duration of Intrathecal Fentanyl Analgesia   [ Time Frame: Time (0-1440 minutes) to first analgesia request ]

Measure Type Primary
Measure Title Duration of Intrathecal Fentanyl Analgesia
Measure Description Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery
Time Frame Time (0-1440 minutes) to first analgesia request  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Laboring parturients that received intrathecal fentanyl (25 micrograms) for initiation of labor analgesia were evaluated for this outcome per protocol.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Measured Values
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
Number of Participants Analyzed  
[units: participants]
  144     46     0     0  
Duration of Intrathecal Fentanyl Analgesia  
[units: Minutes]
Median ( 95% Confidence Interval )
  70  
  ( 62 to 78 )  
  63  
  ( 50 to 76 )  
   
   
   
   


Statistical Analysis 1 for Duration of Intrathecal Fentanyl Analgesia
Groups [1] Labor Analgesia OPRM1 c304A vs. Labor Analgesia OPRM1 c304A>G
Method [2] Log Rank
P Value [3] 0.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Log rank test
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Duration of Intrathecal Analgesia Following Cesarean Delivery   [ Time Frame: 0 to 72 hours following cesarean delivery ]

Measure Type Primary
Measure Title Duration of Intrathecal Analgesia Following Cesarean Delivery
Measure Description Time until request for supplemental analgesia following intrathecal morphine/fentanyl for cesarean delivery
Time Frame 0 to 72 hours following cesarean delivery  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects that received fentanyl and morphine for postpartum analgesia after planned cesarean delivery were analyzed per protocol.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Measured Values
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
Number of Participants Analyzed  
[units: participants]
  0     0     78     25  
Duration of Intrathecal Analgesia Following Cesarean Delivery  
[units: Hours]
Median ( Inter-Quartile Range )
   
   
   
   
  26  
  ( 0 to 47 )  
  40  
  ( 0 to 60 )  


Statistical Analysis 1 for Duration of Intrathecal Analgesia Following Cesarean Delivery
Groups [1] Cesarean Delivery OPRM1 c304A vs. Cesarean Delivery OPRM1 c304A>G
Method [2] Log Rank
P Value [3] 0.15
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Primary:   Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention   [ Time Frame: VAS at analgesia request ]

Measure Type Primary
Measure Title Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention
Measure Description Visual analog pain scale (0 to 100) at 1st request for supplemental analgesia
Time Frame VAS at analgesia request  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population per protocol.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Measured Values
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
Number of Participants Analyzed  
[units: participants]
  144     46     78     25  
Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention  
[units: Units on a scale]
Median ( Inter-Quartile Range )
  33  
  ( 21 to 50 )  
  38  
  ( 23 to 51 )  
  26  
  ( 0 to 47 )  
  40  
  ( 0 to 60 )  


Statistical Analysis 1 for Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention
Groups [1] Labor Analgesia OPRM1 c304A vs. Labor Analgesia OPRM1 c304A>G
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.23
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Visual Analog Pain Scale (0 to 100) at Analgesia Request Following Intrathecal Intervention
Groups [1] Cesarean Delivery OPRM1 c304A vs. Cesarean Delivery OPRM1 c304A>G
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.84
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Severity of Pruritus Following Fentanyl   [ Time Frame: Labor analgesia ]

Measure Type Secondary
Measure Title Severity of Pruritus Following Fentanyl
Measure Description Severity of pruritus during labor analgesia
Time Frame Labor analgesia  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Measured Values
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
Number of Participants Analyzed  
[units: participants]
  144     46     0     0  
Severity of Pruritus Following Fentanyl  
[units: participants]
       
None     9     13          
Mild     48     59          
Moderate     35     26          
Severe     8     2          


Statistical Analysis 1 for Severity of Pruritus Following Fentanyl
Groups [1] Labor Analgesia OPRM1 c304A vs. Labor Analgesia OPRM1 c304A>G
Method [2] Chi-squared, Corrected
P Value [3] 0.06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Subjects With Pruritus at 24 Hours Post Morphine   [ Time Frame: 24 hours post cesarean delivery ]

Measure Type Secondary
Measure Title Subjects With Pruritus at 24 Hours Post Morphine
Measure Description Subjects reporting pruritus in the first 24 hours post cesarean delivery
Time Frame 24 hours post cesarean delivery  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Labor Analgesia OPRM1 c304A Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
Labor Analgesia OPRM1 c304A>G Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
Cesarean Delivery OPRM1 c304A Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
Cesarean Delivery OPRM1 c304A>G Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G

Measured Values
    Labor Analgesia OPRM1 c304A     Labor Analgesia OPRM1 c304A>G     Cesarean Delivery OPRM1 c304A     Cesarean Delivery OPRM1 c304A>G  
Number of Participants Analyzed  
[units: participants]
  0     0     78     25  
Subjects With Pruritus at 24 Hours Post Morphine  
[units: participants]
          33     3  


Statistical Analysis 1 for Subjects With Pruritus at 24 Hours Post Morphine
Groups [1] Cesarean Delivery OPRM1 c304A vs. Cesarean Delivery OPRM1 c304A>G
Method [2] Chi-squared, Corrected
P Value [3] 0.02
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A limitation to the finding of this study was the relatively low number of OPRM1 heterozygous subjects.


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