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Hypnosis is an effective pain management tool for surgery that can reduce opioid use up to 40%. COMT single nucleotide polymorphisms (SNPs) can predict pain sensitivity and opioid use perioperatively, and may also be associated with hypnotizability or response to hypnotic analgesia. Analyzing COMT haplotypes from DNA extracted from saliva or blood using a giant magnetoresistive (GMR) nanotechnology platform may be faster, less expensive, and at least as accurate as pyrosequencing. This study aims to validate a multi-SNP point-of-care (POC) GMR assay for the rapid genotyping of SNPs predictive of COMT activity, and test the feasibility of using COMT activity as a biomarker for hypnotizability and/or response to hypnotic analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HIP previously measured | This cohort of patients will have their genetics analyzed and compared to their HIP scores. |
| |
| Participants without HIP measured | This cohort of patients from the control group of the knee replacement trial (who did not have their HIP measured) will have their genetics, pain, and opioid use analyzed, and compared to the genetics, pain, and opioid use of the hypnosis group from that trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giant magnetoresistive sensor (GMR) | Device | Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing | We will test the hypothesis that the four COMT SNPs (rs4680, rs4818, rs4633, and rs6269) can be detected on the GMR platform with 99% accuracy when compared to pyrosequencing | Through study completion, average of 2 years |
| Determine which COMT SNP haplotypes associate with high/medium/low hypnotizability measured by the Hypnotic Induction Profile score. | Through study completion, average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine which COMT diplotypes/haplotypes associate with high/medium/low postoperative opioid use in milligram morphine equivalents/hour/kilogram of body weight (MME/kg/hr), and high/medium/low average pain scores on the Numeric Pain Scale. | Determine if there is a relationship between COMT diplotypes/haplotypes and pain or opioid use in a subgroup of patients who underwent hypnosis prior to knee replacement surgery vs. patients in the control group who were not hypnotized, during their inpatient admission postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in this trial are drawn from three prior trials. One trial measured hypnotizability and collected genetic samples with permission to use for future research, 23 samples will be drawn from this cohort. The second trial measured hypnotizability in healthy volunteers, 42 participants agreed to be contacted for future studies will be invited to participate by submitting a saliva sample for DNA analysis. The third trial used hypnotic analgesia for knee replacement surgery, approximately 32 patients had hypnotizability tested and will be invited to participate for the primary analysis. Another approximately 30 patients from the control group of that trial had pain and opioid use collected postoperatively, and will be invited to provide genetic sample to be used for the secondary outcome analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Shan Wang, PhD | Stanford University | Principal Investigator |
| David Spiegel, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University/Stanford Healthcare | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020022 | Genetic Predisposition to Disease |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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Saliva samples for DNA analysis
| Through study completion, average of 2 years |
| D012816 | Signs and Symptoms |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |