Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Pain, Postoperative Clinical Trial

— RA-TLH  

Official title:

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429022
• Other study ID #: STUDY00004549
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Gabapentin
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
• Acetaminophen
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
• Celecoxib
Celecoxib 200mg PO q 12h x 7d post op
• Ketorolac
30mg IV once at end of hysterectomy procedure

Procedure:
• Paracervical block with ropivacaine
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
• 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
• Oxycodone
To be discharged home with: 12 tabs of 5mg PRN q4h

Locations

Country	Name	City	State
United States	Millard Fillmore Suburban Hospital	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & 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

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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain Scores	Subjective, Score 0-10 with 0 being no pain and 10 being severe pain	3-24 hours after surgery
Secondary	Pain Scores	Subjective, Score 0-10 with 0 being no pain and 10 being severe pain	0-3 hours after surgery
Secondary	Length of Stay in Hours	Length of stay in hours	0- 240 hours
Secondary	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
Secondary	Operative Time	minutes	0-300 minutes
Secondary	Estimated Blood Loss	milliliters (mL)	0-300 minutes