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Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.
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The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.
In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.
The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine plus Magnesium sulfate | Active Comparator | Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose |
|
| Placebo | Placebo Comparator | Normal Saline (NaCl 0.9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine plus Magnesium sulfate | Drug | Patients will receive 2 IV infusions:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain score using the Numeric Rating Scale (NRS) | Patient described pain level on a scale of 0-10 | 1st 24 hours post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative opioid use | Dilaudid and Oxycodone in mg. | 24 hours post operative |
| Recovery Questionnaire | Patient perception of quality of recovery as measured by the QoR-40 Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey Duryea, DO | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate |
|
|
| 3-5 days post operative |
| Intraoperative fentanyl use | Amount of fentanyl used intra-operatively in mcg. | Intraoperative |
| Nausea Scores using PONV Impact Scale Score | Patient described nausea level using 2 questions each with 4 answers with numerical value from 0-3. To calculate the PONV Impact Scale score, the numerical responses to questions 1 and 2 are added to obtain the PONV impact scale score. A PONV Impact Scale score of ≥5 defines clinically important PONV. | 24 hours Post operative |
| Length of Hospital Stay | Number of days the patient was an inpatient in the hospital. | 24 hours Post operative |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |