Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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) Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area) Intra-Op: Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL Will operate at <15mmHg intra-abdominal pressure with goal of <12mmHg At end of procedure during closure of fascia, give 30mg ketorolac IV x 1 Post-Op: Gabapentin 300mg PO BID for 7 days Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN Celecoxib 200mg PO q 12h x 7d Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge Also include standard post-op medications such as zofran, reglan, mylicon… 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.

Official Title
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Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Acetaminophen
* Drug: Celecoxib
* Drug: Ketorolac
* Procedure: Paracervical block with ropivacaine
* Procedure: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
* Drug: Hydromorphone
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy Uterine weight ≤325 grams Exclusion Criteria: contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD) current opioid prescription

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective cohort with retrospective controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective cohort<br>Pre-Op: Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op) Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Intra-Op: Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg At end of procedure during closure of fascia, give 30mg ketorolac IV x 1 Post-Op: Gabapentin 300mg PO BID for 7 days Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN Celecoxib 200mg PO q 12h x 7d Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge | Drug: Gabapentin<br>* 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op<br>Drug: Acetaminophen<br>* Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op<br>* Other names: Tylenol;Drug: Celecoxib<br>* Celecoxib 200mg PO q 12h x 7d post op<br>* Other names: Celebrex;Drug: Ketorolac<br>* 30mg IV once at end of hysterectomy procedure<br>* Other names: Toradol;Procedure: Paracervical block with ropivacaine<br>* 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL<br>Procedure: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites<br>* 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total<br>Drug: Hydromorphone<br>* 1mg IV PRN q3h, post op, while inpatient<br>* Other names: Dilaudid;Drug: Oxycodone<br>* To be discharged home with: 12 tabs of 5mg PRN q4h<br>|
| Active Comparator: Historical Control<br>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge | Drug: Hydromorphone<br>* 1mg IV PRN q3h, post op, while inpatient<br>* Other names: Dilaudid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy