Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00418015 · ClinicalTrials.gov registry record
Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia
A clinical trial of Labor Pain and Post-cesarean Delivery, sponsored by Northwestern University.
- Completed
- Registry status
- 293
- Enrollment target
- 1
- Study location
NCT00418015: Completed study of Labor Pain and Post-cesarean Delivery, sponsored by Northwestern University.
NCT00418015 is a study of Labor Pain and Post-cesarean Delivery that has completed, run by Northwestern University. The registered enrollment target is 293 participants, above the 183-participant average among 14 other Labor Pain trials with a reported enrollment target (60% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00418015, a study of Labor Pain and Post-cesarean Delivery, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 293 participants
- Enrollment target
- 1
- Study location
Study Summary
Pharmacogenetics has allowed clinicians to identify associations between an individual's genetic profile and his/her response to drugs. The A118G (c.188A\>G)is a single nucleotide polymorphism (SNP) of the mu-opioid receptor (OPRM1). The mutated protein, N40D, appears to increase the binding affinity and potency of beta-endorphin approximately 3-fold. Individuals carrying the variant receptor gene (A118G) may show differences in some of the functions mediated by beta-endorphin action at the altered OPRM1. Combined spinal-epidural (CSE) analgesia is a commonly utilized technique for labor analgesia. Analgesia is initiated with the intrathecal administration of a lipid-soluble opioid (e.g. fentanyl), sometimes combined with a local anesthetic. The mean (± SD) duration of analgesia after intrathecal fentanyl 25 microgram was 89 ± 43 min. The ED50 of intrathecal fentanyl for labor analgesia varies between 14 microgram to 18.2 microgram. The wide variability in the duration of analgesia, as was well the differences in ED50 may result from differences known to affect labor pain (e.g., ethnicity, parity, stage of labor). Another possible explanation for the differences in opioid requirements and duration, as well as incidence of side effects such as itching and nausea/vomiting, is that opioid responsiveness is determined by genetic variability of the µ-opioid receptor. The ED50 for intrathecal fentanyl labor analgesia was significantly lower for parturients carrying the A118G variant of the mu-opioid receptor, compared to parturients with the A118 wild type receptor. The purpose of this study is to determine whether polymorphism at nucleotide 118 of OPRM1 influences the duration of intrathecal opioid (fentanyl) labor analgesia, and intrathecal opioid (morphine) postoperative analgesia.
Primary Outcome
Time from intrathecal drug administration to request for analgesia either in laboring women of after cesarean delivery
Conditions Studied
Interventions
- PROCEDURE Blood Draw
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-06 |
What the finished NCT00418015 record still lists
NCT00418015 is an observational study that tracks outcomes without assigning an intervention. The registered 293 participants enrollment target is mid-sized for trials with a published cap, above the 183-participant average among 14 other Labor Pain trials with a reported enrollment target (60% higher).
The record links to 2 conditions, with Labor Pain appearing as the primary indexed condition, and to 1 intervention - of which Blood Draw is the first listed.
NCT00418015 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00418015 about?
NCT00418015 is a clinical study titled "Mu-Opioid Receptor Genetic Polymorphism and Intrathecal Analgesia". Pharmacogenetics has allowed clinicians to identify associations between an individual's genetic profile and his/her response to drugs. The A118G (c.188A\>G)is a single nucleotide polymorphism (SNP) of the mu-opioid receptor (OPRM1). The mutated protein, N40D, appears to increase the binding affinit...
What is the current status of trial NCT00418015?
This trial is currently completed. The enrollment target is 293 participants. The study started on 2005-10. Estimated completion is 2007-06.
What conditions does trial NCT00418015 study?
This clinical trial studies the following conditions: Labor Pain, Post-cesarean Delivery.
What interventions are being tested in trial NCT00418015?
The interventions under investigation include: Blood Draw (PROCEDURE).
Who is sponsoring clinical trial NCT00418015?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00418015 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Labor Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00418015's enrollment target sits among peer trials
293 3rd of 14 higher than 12 of 14 other Labor Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Labor Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Stimulation To Induce Mothers Study
RECRUITING · Phase 4
-
ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
RECRUITING · Phase 4
-
Intracervical Balloon Placement With Nitrous Oxide Administration
RECRUITING · Phase 3
-
CSE v. Epidural for Postpartum Depression
COMPLETED · NA
-
Virtual Reality Compared to Nitrous Oxide for Labor Analgesia
COMPLETED · NA
-
Comparison of PIEB vs CEI for Labor Analgesia
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05775159 · 294 participants · Phase 2
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
- NCT06262113 · 294 participants · NA
A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1
- NCT06338865 · 294 participants · NA
Short Title: Standard vs. Lower Pressure Pneumoperitoneum
- NCT06395467 · 294 participants · NA
Integrated Treatment for Enhancing Growth in Recovery During Adolescence
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia