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| ID | Type | Description | Link |
|---|---|---|---|
| Hydromorphone_IT | Other Identifier | BrighamHospital |
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Research question answered by another group of researchers (Sviggum et al)
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Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery.
For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.
Intrathecal opioids in have been shown to produce analgesia. Lipid solubility and effect on specific mu opioid receptors in the dorsal horn of the spinal cord primarily determine the analgesic effect of intrathecally injected opioids. Rostral spread of intrathecal opioids causes some of the side effects like pruritus, respiratory depression, nausea and vomiting.
In the investigators' institute, during cesarean delivery under spinal anesthesia is usually performed with 1.6-1.8 ml of 0.75% bupivacaine with dextrose (hyperbaric solution) with 10-20mcg of fentanyl. Preservative free intrathecal (IT) morphine100 to 200 mcg is injected at the time of initiation of spinal block for postoperative pain relief. Multiple studies have shown excellent postoperative pain relief following cesarean delivery up to 18hrs with this dosing regimen.
However, there has been a national shortage of preservative free morphine since August 2012. Based on the pharmacokinetic and pharmacodynamic profile, intrathecal (IT) preservative free hydromorphone 100 mcg has been used as a substitute. Anecdotal experience during the past 8 months suggest that patients have comparable post partum pain relief, with a similar side-effect profile to IT morphine.
There is no published data on the optimal dose of IT hydromorphone for post cesarean analgesia. There are case reports and retrospective case study of use of 100mcg IT hydromorphone. One randomized controlled trial for knee arthroscopy used 2.5-5-10 mcg of IT hydromorphone for postoperative analgesia.
Hence it is important to determine the optimal dose of IT hydromorphone for post operative pain management following cesarean delivery in terms of analgesic efficacy, incidence of side effects and the need for treatment interventions
This study will aim to determine the optimal dose of intrathecal hydromorphone that would provide adequate postoperative analgesia with minimal side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone 25mcg | Active Comparator | The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia |
|
| Hydromorphone 50mcg | Active Comparator | The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia |
|
| Hydromorphone 100mcg | Active Comparator | The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone 25mcg | Drug | Intrathecal Hydromorphone 25mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24hr Post-partum IV Opioid Requirement | Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements. | 24hrs after administration of intrathecal hydromorphone |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation, Need for Supplemental Oxygen | Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice). | 24hrs post administration of IT hydromorphone |
| Patients With Nausea and Vomiting Requiring Rescue Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk J Varelmann, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 373503 | Background | Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available. | |
| 2888557 | Background | Ross BK, Hughes SC. Epidural and spinal narcotic analgesia. Clin Obstet Gynecol. 1987 Sep;30(3):552-65. doi: 10.1097/00003081-198709000-00010. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone 25mcg | The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| FG001 | Hydromorphone 50mcg | The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| FG002 | Hydromorphone 100mcg | The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydromorphone 25mcg | The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| BG001 | Hydromorphone 50mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 24hr Post-partum IV Opioid Requirement | Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements. | One 25 mcg patient is missing data on this outcome | Posted | Mean | Standard Deviation | mg | 24hrs after administration of intrathecal hydromorphone |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydromorphone 25mcg | The arm will receive 25mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 25mcg: Intrathecal Hydromorphone 25mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dirk J Varelmann, MD | Brigham and Women's Hospital | 617-732-8280 | dvarelmann@partners.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Hydromorphone 50mcg | Drug | Intrathecal Hydromorphone 50mcg |
|
|
| Hydromorphone 100mcg | Drug | Intrathecal Hydromorphone 100mcg |
|
|
| spinal anesthesia | Drug | bupivacaine 0.75% 1.6 mL (12mg) |
|
IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication. |
| 24hrs post administration of IT hydromorphone |
| Number of Patients With Hypothermia (Body Temperature < 95F/35C) | intrathecally administered opioids can cause hypothermia (body temperature <95F/35C) | 24hrs post administration of IT hydromorphone |
| Number of Patients With Visual Disturbances | IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported. | 24hrs post administration of IT hydromorphone |
| Number of Patients With Pruritus | IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded. | 24hrs post administration of IT hydromorphone |
| Intraoperative Vasopressor Use: Ephedrine Equivalents | IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents. | Intraoperatively (at time of operation) |
| Intraoperative Vasopressor Use: Phenylephrine Equivalents | IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for phenylephrine equivalents. | Intraoperatively (at time of operation) |
| 9952150 | Background | Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018. |
| 8882255 | Background | Milner AR, Bogod DG, Harwood RJ. Intrathecal administration of morphine for elective Caesarean section. A comparison between 0.1 mg and 0.2 mg. Anaesthesia. 1996 Sep;51(9):871-3. doi: 10.1111/j.1365-2044.1996.tb12622.x. |
| 21562420 | Background | Lee YS, Park YC, Kim JH, Kim WY, Yoon SZ, Moon MG, Min TJ. Intrathecal hydromorphone added to hyperbaric bupivacaine for postoperative pain relief after knee arthroscopic surgery: a prospective, randomised, controlled trial. Eur J Anaesthesiol. 2012 Jan;29(1):17-21. doi: 10.1097/EJA.0b013e3283476055. |
The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| BG002 | Hydromorphone 100mcg | The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
| OG002 | Hydromorphone 100mcg | The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) |
|
|
| Secondary | Oxygen Saturation, Need for Supplemental Oxygen | Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice). | One 25 mcg patient is missing data on this outcome | Posted | Mean | Standard Deviation | percentage oxygenated haemoglobin | 24hrs post administration of IT hydromorphone |
|
|
|
| Secondary | Patients With Nausea and Vomiting Requiring Rescue Medication | IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication. | One 25 mcg patient was missing data on this measure | Posted | Count of Participants | Participants | 24hrs post administration of IT hydromorphone |
|
|
|
| Secondary | Number of Patients With Hypothermia (Body Temperature < 95F/35C) | intrathecally administered opioids can cause hypothermia (body temperature <95F/35C) | One 25 mcg patient was missing data on this measure | Posted | Count of Participants | Participants | 24hrs post administration of IT hydromorphone |
|
|
|
| Secondary | Number of Patients With Visual Disturbances | IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported. | Posted | Count of Participants | Participants | 24hrs post administration of IT hydromorphone |
|
|
|
| Secondary | Number of Patients With Pruritus | IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded. | One 25 mcg patient is missing data on this outcome | Posted | Count of Participants | Participants | 24hrs post administration of IT hydromorphone |
|
|
|
| Secondary | Intraoperative Vasopressor Use: Ephedrine Equivalents | IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents. | One 25 mcg patient is missing data on this outcome | Posted | Mean | Standard Deviation | mg | Intraoperatively (at time of operation) |
|
|
|
| Secondary | Intraoperative Vasopressor Use: Phenylephrine Equivalents | IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for phenylephrine equivalents. | One 25 mcg patient is missing data on this outcome | Posted | Mean | Standard Deviation | mcg | Intraoperatively (at time of operation) |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Hydromorphone 50mcg | The arm will receive 50mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 50mcg: Intrathecal Hydromorphone 50mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) | 0 | 9 | 1 | 9 |
| EG002 | Hydromorphone 100mcg | The arm will receive 100mcg intrathecal hydromorphone to supplement the spinal anesthesia Hydromorphone 100mcg: Intrathecal Hydromorphone 100mcg spinal anesthesia: bupivacaine 0.75% 1.6 mL (12mg) | 0 | 9 | 1 | 9 |
| Pain | General disorders |
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| Dizziness | Nervous system disorders |
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| Nausea | Gastrointestinal disorders |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |