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Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.
Material and Methods:
This is a prospective cohort study with historical controls. Cases of those receiving a non-opioid multimodal pain regimen will be compared to historical controls of those receiving a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325 grams will be included in this study. Multimodal pain regimen will include the following:
Protocol:
Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area)
Intra-Op:
Post-Op:
Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes include pain scores as rated subjectively by the patient, length of stay in hours and whether the patient returns to the clinic or emergency department due to post operative pain within a 2 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort | Experimental | Pre-Op:
Intra-Op:
Post-Op:
|
|
| Historical Control | Active Comparator | Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) | Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) | 0-3 hours after surgery |
| Total Opioid Pain Medications Required Through 3-24h Post op in MME | Total opioid pain medications required through 3-24h post op in MME | 3-24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Subjective, Score 0-10 with 0 being no pain and 10 being severe pain | 3-24 hours after surgery |
| Pain Scores | Subjective, Score 0-10 with 0 being no pain and 10 being severe pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Andres, D.O. | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Millard Fillmore Suburban Hospital | Williamsville | New York | 14221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Adajar, A. (2018). 73: Eliminating post-operative narcotic use after mini-laparoscopic hysterectomy: Effectiveness of a multimodal pain management regimen adopted into clinical practice. American Journal of Obstetrics and Gynecology, 218(2), S937-S938. https://doi.org/10.1016/j.ajog.2017.12.092 | ||
| 28043841 | Background | Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30. | |
| Background | Chopra, V., Kown, D., & Sangha, R. (2018). Decreasing Postoperative Narcotic Use for Patients Undergoing Hysterectomy. Journal of Minimally Invasive Gynecology, 25(7), S194-S194. https://doi.org/10.1016/j.jmig.2018.09.526 | ||
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IPD will not be available to other researchers
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49 patients were analyzed as 18 of 28 intervention arm participants did not receive the intervention or their care required deviation from the from study protocol (e.g., no minimally invasive hysterectomy due to laparotomy, no paracervical block due to indocyanine green injection for lymph node mapping, no postoperative protocol medications due to limited resources and logistical issues). One of the 40 control participants was excluded due to uterine weight exceeding the study protocol range.
For the intervention arm, patients were recruited from November 24, 2020 to May 24, 2022. Data for the retrospective controls who underwent their hysterectomy from 11/27/2018 to 12/12/2019, was obtained via chart review. This was a prospective cohort study with retrospective controls. To allow for adjustment to this new protocol, 11 months were allocated to the institution and staff, prior to enrolling patients in the intervention arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Cohort | Pre-Op:
Intra-Op:
Post-Op:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2023 |
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Prospective cohort with retrospective controls
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| Acetaminophen | Drug | Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op |
|
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| Celecoxib | Drug | Celecoxib 200mg PO q 12h x 7d post op |
|
|
| Ketorolac | Drug | 30mg IV once at end of hysterectomy procedure |
|
|
| Paracervical block with ropivacaine | Procedure | 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL |
|
| Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites | Procedure | 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total |
|
| Hydromorphone | Drug | 1mg IV PRN q3h, post op, while inpatient |
|
|
| Oxycodone | Drug | To be discharged home with: 12 tabs of 5mg PRN q4h |
|
| 0-3 hours after surgery |
| Length of Stay in Hours | Length of stay in hours | 0- 240 hours |
| Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period | Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period | 0-14 days |
| Operative Time | minutes | 0-300 minutes |
| Estimated Blood Loss | milliliters (mL) | 0-300 minutes |
| Background |
| Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452. |
| FG001 | Historical Control | Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge Hydromorphone: 1mg IV PRN q3h, post op, while inpatient |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Cohort | Pre-Op:
Intra-Op:
Post-Op:
|
| BG001 | Historical Control | Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge Hydromorphone: 1mg IV PRN q3h, post op, while inpatient |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 | Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) | Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) | Posted | Mean | Full Range | morphine milligram equivalents (MME) | 0-3 hours after surgery |
|
|
| |||||||||||||||||||||||||||||
| Primary | Total Opioid Pain Medications Required Through 3-24h Post op in MME | Total opioid pain medications required through 3-24h post op in MME | Posted | Mean | Full Range | morphine milligram equivalents (MME) | 3-24 hours after surgery |
| |||||||||||||||||||||||||||||||
| Secondary | Pain Scores | Subjective, Score 0-10 with 0 being no pain and 10 being severe pain | Posted | Mean | Full Range | score on a scale | 3-24 hours after surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pain Scores | Subjective, Score 0-10 with 0 being no pain and 10 being severe pain | Posted | Mean | Full Range | score on a scale | 0-3 hours after surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Length of Stay in Hours | Length of stay in hours | Posted | Mean | Full Range | hours | 0- 240 hours |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period | Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period | Posted | Count of Participants | Participants | 0-14 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Operative Time | minutes | Posted | Mean | Full Range | minutes | 0-300 minutes |
|
| ||||||||||||||||||||||||||||||
| Secondary | Estimated Blood Loss | milliliters (mL) | Posted | Mean | Full Range | milliliters | 0-300 minutes |
|
|
14 days
All participants were assessed for adverse events
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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 | Prospective Cohort | Pre-Op:
Intra-Op:
Post-Op:
| 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Historical Control | Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge Hydromorphone: 1mg IV PRN q3h, post op, while inpatient | 0 | 39 | 0 | 39 | 0 | 39 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sarah Andres, PI | University at Buffalo | 7163230631 | seandres@buffalo.edu |
| May 10, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2020 | Jul 28, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000082 | Acetaminophen |
| D000068579 | Celecoxib |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000773 | Anesthesia, Obstetrical |
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| D004091 | Hydromorphone |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003061 | Codeine |
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