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Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy (RA-TLH)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Acetaminophen
Celecoxib
Ketorolac
Paracervical block with ropivacaine
Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
Hydromorphone
Oxycodone
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Hysterectomy

Eligibility Criteria

25 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Millard Fillmore Suburban Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prospective cohort

Historical Control

Arm Description

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

Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge

Outcomes

Primary Outcome Measures

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)
Total Opioid Pain Medications Required Through 3-24h Post op in MME
Total opioid pain medications required through 3-24h post op in MME

Secondary Outcome Measures

Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Length of Stay in Hours
Length of stay in 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
Operative Time
minutes
Estimated Blood Loss
milliliters (mL)

Full Information

First Posted
April 28, 2020
Last Updated
July 28, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04429022
Brief Title
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Acronym
RA-TLH
Official Title
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Hysterectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Prospective cohort with retrospective controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective cohort
Arm Type
Experimental
Arm Description
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
Arm Title
Historical Control
Arm Type
Active Comparator
Arm Description
Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Celecoxib 200mg PO q 12h x 7d post op
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
30mg IV once at end of hysterectomy procedure
Intervention Type
Procedure
Intervention Name(s)
Paracervical block with ropivacaine
Intervention Description
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
Intervention Description
0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dilaudid
Intervention Description
1mg IV PRN q3h, post op, while inpatient
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
To be discharged home with: 12 tabs of 5mg PRN q4h
Primary Outcome Measure Information:
Title
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
Description
Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
Time Frame
0-3 hours after surgery
Title
Total Opioid Pain Medications Required Through 3-24h Post op in MME
Description
Total opioid pain medications required through 3-24h post op in MME
Time Frame
3-24 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Time Frame
3-24 hours after surgery
Title
Pain Scores
Description
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Time Frame
0-3 hours after surgery
Title
Length of Stay in Hours
Description
Length of stay in hours
Time Frame
0- 240 hours
Title
Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
Description
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
Title
Operative Time
Description
minutes
Time Frame
0-300 minutes
Title
Estimated Blood Loss
Description
milliliters (mL)
Time Frame
0-300 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Andres, D.O.
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Millard Fillmore Suburban Hospital
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be available to other researchers
Citations:
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
Results Reference
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PubMed Identifier
28043841
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.
Results Reference
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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
Results Reference
background
PubMed Identifier
30646274
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.
Results Reference
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Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

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