Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

NCT04429022 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STUDY00004549
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Hysterectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pain Scores

  3-24 hours after surgery

• Pain Scores

  0-3 hours after surgery

• 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

  0-14 days

• Operative Time

  0-300 minutes

Study Arms (2)

Prospective cohort

EXPERIMENTAL

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; 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

Historical Control

ACTIVE COMPARATOR

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

Drug: Hydromorphone

Interventions

Gabapentin DRUG

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

Prospective cohort

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

Also known as: Tylenol

Prospective cohort

Celecoxib DRUG

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

Also known as: Celebrex

Prospective cohort

Ketorolac DRUG

30mg IV once at end of hysterectomy procedure

Also known as: Toradol

Prospective cohort

Paracervical block with ropivacaine PROCEDURE

0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL

Prospective cohort

Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites PROCEDURE

0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total

Prospective cohort

Hydromorphone DRUG

1mg IV PRN q3h, post op, while inpatient

Also known as: Dilaudid

Historical Control; Prospective cohort

Oxycodone DRUG

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

Prospective cohort

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
• Uterine weight ≤325 grams

You may not qualify if:

• contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
• current opioid prescription

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Millard Fillmore Suburban Hospital

Williamsville, New York, 14221, United States

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 28043841 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30646274 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Acetaminophen; Celecoxib; Ketorolac; Ketorolac Tromethamine; Anesthesia, Obstetrical; Ropivacaine; Anesthetics, Local; Hydromorphone; Oxycodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anesthesia; Anesthesia and Analgesia; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Results Point of Contact

• Title: Dr Sarah Andres, PI
• Organization: University at Buffalo

seandres@buffalo.edu

7163230631

Study Officials

• Sarah Andres, D.O.

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective cohort with retrospective controls

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: June 11, 2020
• Study Start: November 24, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)