Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Gabapentin; Acetaminophen; Celecoxib; Ketorolac; Paracervical block with ropivacaine; Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites; Hydromorphone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure; Drug; Drug
Intervention description(s): 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op; Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op; Celecoxib 200mg PO q 12h x 7d post op; 30mg IV once at end of hysterectomy procedure; 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL; 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total; 1mg IV PRN q3h, post op, while inpatient; To be discharged home with: 12 tabs of 5mg PRN q4h
Other intervention name(s): Tylenol; Celebrex; Toradol; Dilaudid
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Oxycodone; Gabapentin; Hydromorphone; Ropivacaine; Anesthetics, Local; Anesthetics
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Prospective cohort with retrospective controls
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hysterectomy