Pain, PostoperativePhase 3RA-TLHNCT04429022
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
A Phase 3 study testing Gabapentin, Acetaminophen and Celecoxib in people with Pain, Postoperative, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin, Acetaminophen and Celecoxib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 31 May 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
- Uterine weight ≤325 grams
Who cannot join
- contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
- current opioid prescription
Trial locations and contacts
1 site in 1 country.
United States1 site
Millard Fillmore Suburban Hospital
Williamsville, New York, 14221
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin, Acetaminophen, Celecoxib, Ketorolac, Paracervical block with ropivacaine
- Keywords
- Hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
AcetaminophenDrug
Also called Tylenol
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
CelecoxibDrug
Also called Celebrex
Celecoxib 200mg PO q 12h x 7d post op
KetorolacDrug
Also called Toradol
30mg IV once at end of hysterectomy procedure
Paracervical block with ropivacaineProcedure or surgery
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
Local anesthetic injection with ropivacaine at abdominal laparoscopic port sitesProcedure or surgery
0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
HydromorphoneDrug
Also called Dilaudid
1mg IV PRN q3h, post op, while inpatient
OxycodoneDrug
To be discharged home with: 12 tabs of 5mg PRN q4h
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 3-24 hours after surgery
Secondary outcomes (6)
Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Measured: 3-24 hours after surgery
Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Measured: 0-3 hours after surgery
Length of Stay in Hours
Length of stay in hours
Measured: 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
Measured: 0-14 days
Operative Time
minutes
Measured: 0-300 minutes
Estimated Blood Loss
milliliters (mL)
Measured: 0-300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start24 Nov 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective cohort with retrospective controls
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Andres, D.O., State University of New York at Buffalo
- Investigators
- Sarah Andres, D.O., Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429022
- Sponsor's protocol ID
- STUDY00004549
- Acronym
- RA-TLH
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers
Publications
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.
PubMed 28043841Chopra, 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.
PubMed 30646274
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04429022
- Acronym / sponsor ID
- RA-TLH / STUDY00004549
- Conditions
- Pain, Postoperative
- Keywords
- Hysterectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort with retrospective controls
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | 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: OxycodonePre-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 |
| Historical Control | Active comparator | Drug: HydromorphoneTraditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
- Uterine weight ≤325 grams
Key exclusion criteria (2 listed)
- contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
- current opioid prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op | Drug | Prospective cohort |
| AcetaminophenAlso: TylenolAcetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op | Drug | Prospective cohort |
| CelecoxibAlso: CelebrexCelecoxib 200mg PO q 12h x 7d post op | Drug | Prospective cohort |
| KetorolacAlso: Toradol30mg IV once at end of hysterectomy procedure | Drug | Prospective cohort |
| Paracervical block with ropivacaine0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL | Procedure or surgery | Prospective cohort |
| Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total | Procedure or surgery | Prospective cohort |
| HydromorphoneAlso: Dilaudid1mg IV PRN q3h, post op, while inpatient | Drug | Historical Control, Prospective cohort |
| OxycodoneTo be discharged home with: 12 tabs of 5mg PRN q4h | Drug | Prospective cohort |
Primary outcome
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)
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
6 secondary outcomes
Pain Scores
Time frame: 3-24 hours after surgery
Pain Scores
Time frame: 0-3 hours after surgery
Length of Stay in Hours
Time frame: 0- 240 hours
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
Operative Time
Time frame: 0-300 minutes
Estimated Blood Loss
Time frame: 0-300 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAdajar, 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: PubMed 28043841Blanton 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.
- BackgroundChopra, 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: PubMed 30646274Mark 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.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Andres, D.O. principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin, Acetaminophen and Celecoxib in people with Pain, Postoperative, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) (time frame: 0-3 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04429022, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.