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Completed

NCT Number: NCT04429022

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

25 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Millard Fillmore Suburban Hospital

Williamsville, New York, 14221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op

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

Other names: Tylenol

Celecoxib

Drug

Celecoxib 200mg PO q 12h x 7d post op

Other names: Celebrex

Ketorolac

Drug

30mg IV once at end of hysterectomy procedure

Other names: Toradol

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

Other names: Dilaudid

Oxycodone

Drug

To be discharged home with: 12 tabs of 5mg PRN q4h

Primary outcomes

  1. Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)

    Time frame: 0-3 hours after surgery

    Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)

  2. Total Opioid Pain Medications Required Through 3-24h Post op in MME

    Time frame: 3-24 hours after surgery

    Total opioid pain medications required through 3-24h post op in MME

Secondary outcomes

  1. Pain Scores

    Time frame: 3-24 hours after surgery

    Subjective, Score 0-10 with 0 being no pain and 10 being severe pain

  2. Pain Scores

    Time frame: 0-3 hours after surgery

    Subjective, Score 0-10 with 0 being no pain and 10 being severe pain

  3. Length of Stay in Hours

    Time frame: 0- 240 hours

    Length of stay in hours

  4. Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period

    Time frame: 0-14 days

    Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period

  5. Operative Time

    Time frame: 0-300 minutes

    minutes

  6. Estimated Blood Loss

    Time frame: 0-300 minutes

    milliliters (mL)

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Acronym: RA-TLH

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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