Clinical trial NCT04429022: Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Official title: Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Hysterectomy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 68
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective cohort with retrospective controls
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
timeFrame: 0-3 hours after surgery
measure: Total Opioid Pain Medications Required Through 3-24h Post op in MME
timeFrame: 3-24 hours after surgery
Secondary outcomes:
measure: Pain Scores
timeFrame: 3-24 hours after surgery
measure: Pain Scores
timeFrame: 0-3 hours after surgery
measure: Length of Stay in Hours
timeFrame: 0- 240 hours
measure: Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
timeFrame: 0-14 days
measure: Operative Time
timeFrame: 0-300 minutes
measure: Estimated Blood Loss
timeFrame: 0-300 minutes
Other outcomes:
Locations:
city: Williamsville
country: United States
facility: Millard Fillmore Suburban Hospital
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah Andres, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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
citation: 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.