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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Williamsville, New York, United States, 14221
      • Millard Fillmore Suburban Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective cohort; 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; 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op; Drug: Acetaminophen; 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; Drug: Celecoxib; Celecoxib 200mg PO q 12h x 7d post op; Other Names: Celebrex; Drug: Ketorolac; 30mg IV once at end of hysterectomy procedure; Other Names: Toradol; Procedure: Paracervical block with ropivacaine; 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL; Procedure: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites; 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total; Drug: Hydromorphone; 1mg IV PRN q3h, post op, while inpatient; Other Names: Dilaudid; Drug: Oxycodone; To be discharged home with: 12 tabs of 5mg PRN q4h
Active Comparator: Historical Control; Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge	Drug: Hydromorphone; 1mg IV PRN q3h, post op, while inpatient; Other Names: Dilaudid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Sarah Andres, D.O., University at Buffalo

Publications and helpful links

General Publications

• 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.
• 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.
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Cyclooxygenase 2 Inhibitors; Anesthetics; Gabapentin; Ketorolac; Celecoxib; Acetaminophen; Anesthetics, Local; Ropivacaine; Oxycodone; Hydromorphone
• Other Study ID Numbers: STUDY00004549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available to other researchers

Drug and device information, study documents

• 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