AnalgesiaPhase 4NCT05200806
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
A Phase 4 study testing Non-Narcotic ERAS Post-Operative Pain Management in people with Analgesia and Post-Operative Pain, run by University of Vermont at 1 site in United States.
Trial summary
With this pilot investigation, the investigators aim to challenge the reliance on opiate analgesia following colon and rectal surgery. Narcotic misuse and abuse is a pressing public health concern, and reduction in prescription rates could help to mitigate this issue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Post-Operative Pain, Breakthrough Pain
- What is being tested?
- Non-Narcotic ERAS Post-Operative Pain Management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Undergoing elective abdominal colectomy
- Eligible for the Enhanced Recovery After Surgery (ERAS) protocol currently in place for colectomy patients at UVMMC
Who cannot join
- allergy to any protocol medication
- emergent or urgent bowel surgery
- pre-operative plan for a stoma
- pre-operative diagnosis of rectal cancer (pre-operative diagnosis of rectosigmoid cancer is not necessarily excluded)
- neoadjuvant chemoradiation
- additional malignant disease outside of the colon
Show all 11Show fewer
- narcotic usage within the three months of scheduled operation date, for more than one week
- chronic pain
- pain score >2 at the initial evaluation for study inclusion
- dementia
- Note: Eligibility will be determined by the research coordinator and approved by the surgeon
Trial locations and contacts
1 site in 1 country.
OCTR Main Line contact
United States1 site, 1 recruiting
- Recruiting
UVM Medical Center
Burlington, Vermont, 05405
Ethan D Jones, MPH, 802-656-9437, ethan.d.jones@med.uvm.edu
OCTR Main Line, 8026561313
About this study
With this pilot investigation, the investigators aim to challenge the reliance on opiate analgesia following colon and rectal surgery. Narcotic misuse and abuse is a pressing public health concern, and reduction in prescription rates could help to mitigate this issue. The goal of this pilot study is to establish feasibility of sufficient post-operative pain control after colectomy using non-narcotic analgesics. The investigators hypothesize that patients will be able to manage their post-operative pain without narcotic intervention, while minimizing side effects and complications. This initial pilot study will provide proof-of-concept for a larger, randomized investigation on non-narcotic analgesia after colectomy.
Read the detailed description
Our primary objectives are:
- Determine the rate of patients needing rescue narcotics prescriptions for breakthrough postoperative pain after colectomy while on a non-narcotic postoperative protocol.
- Search for patterns pain and in timing of need for narcotic medication (e.g. in PACU, after intrathecal morphine wear off, etc.)
Secondary objectives:
- Measure patient satisfaction with pain management via survey administered at discharge and during the 30 days post-operation. This will include questions regarding medication side-effects.
- Determine factors that may affect patient need for narcotic pain medication, including complications (return to OR, anastomotic leak, prolonged ileus, post-operative hemorrhage), return of bowel function, side effects of medications, and length of hospital stay, which will be taken from patients' charts and surveys for analysis.
Procedures:
At their initial clinic visit for surgical scheduling, patients will be explained appropriate risks and benefits of participating in this pilot program. If interested, patients will choose to opt in to the protocol and consent to participate at this time. Pre-operatively, patients will adhere to the Enhanced Recovery After Surgery (ERAS) protocol in standard use at UVMMC for colectomy patients. This protocol includes administration of gabapentin (900 mg capsule), acetaminophen (1,000 mg tablet), dexamethasone (8 mg intravenously), granisetron (1 mg intravenously), and morphine (0.15 mg intrathecally). Appropriate medications will be administered at the discretion of the treating anesthesiologist during colectomy, but ketamine use will be encouraged if not contraindicated. Following the completion of colectomy, patients will only be given oral acetaminophen (650 mg, every 4 hours), gabapentin (300 mg, every 6 hours), methocarbamol (750mg, 4 times daily), and 5% lidocaine pat (every 12 hours, as needed), for analgesia from their stay in the PACU onwards. A one-time opioid rescue prescription for hydromorphone, morphine, or oxycodone will be available for breakthrough pain during their hospital stay. This differs from standard ERAS post-operative pain management, where hydromorphone, morphine, or oxycodone can be administered as needed. If a patient uses the one-time rescue dose, the covering physician will be notified and can then choose to order an appropriate narcotic regimen for the remainder of the patient's hospitalization. All patients will be discharged with a narcotics prescription that they can choose to fill. Throughout their hospitalization, patients will be asked to provide their pain level on the Visual Analog Scale (VAS) per typical protocol. At discharge, they will be given instructions for weaning pain medications at home. They will also be provided a medication diary, where they will record their pain levels, the time of administration of pain medications, and the name of the medications being administered. A patient satisfaction survey will be provided with the medication diary. The patient will be instructed to fill out the survey when they return home after discharge and to return the survey with their medication diary at their first follow up visit. An automated telephone call will occur daily for 1 week after discharge to remind the patient to record their pain level and medication use in the medication diary. At the patient's follow-up clinic visit, which occurs 3-4 weeks after discharge, the patient will bring their completed medication diary and first satisfaction survey. At this visit, a second patient satisfaction survey will be completed.
Outcome measures will be monitored through use of the rescue prescription while hospitalized, as well as self-reported surveys measuring post-operative pain, protocol side effects, and satisfaction of pain control, which will be given to the patients at discharge and at a follow-up clinic visit. Information on return of bowel function, length of hospital stay, and other medical complications will be gleaned from the patients' charts. Analysis of outcomes will be performed with the aid of a statistician.
- Conditions
- Analgesia, Post-Operative Pain, Breakthrough Pain, Colectomy
- Being tested
- Non-Narcotic ERAS Post-Operative Pain Management
- Medical subject headings
- Agnosia, Pain, Postoperative, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Narcotic ERAS Post-Operative Pain ManagementOther
As described previously.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Pre-Op Enhanced Recovery After Surgery (ERAS): Gabapentin (900mg capsule), Acetaminophen (1,000mg tablet), Dexamethasone (8mg IV), Granisetron (1mg IV), Morphine (0.15mg Intrathecal) Intraoperatively: Appropriate medications administered at discretion of the treating anesthesiologist during colectomy, with Ketamine use encouraged if not contraindicated. Post-Op (PACU, Onward during inpatient stay): Acetaminophen (Oral) (650mg, q4hrs), Gabapentin (300mg, q6hours), Methocarbamol (750mg, QID), 5% Lidocaine Patch (q12hrs PRN) One time rescue dose (Hydromorphone, Morphine, Oxycodone) available for breakthrough pain during hospital stay (differs from traditional ERAS protocol where medications can be administered as needed). If one-time rescue dose is needed, the covering physician will be notified and can choose to order an appropriate narcotic regimen for remainder of patient's hospitalization. All patients are discharged with a narcotics prescription that they can choose to fill. Receives: Other: Non-Narcotic ERAS Post-Operative Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure Rate
Need for rescue narcotics for inadequately controlled pain as indicated in Electronic Medical Record (EMR).
Measured: Until post-op clinic visit (estimated 3-4 weeks post-op)
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction with pain management via satisfaction survey administration at discharge and during the 30 days post-operation.
Measured: Until post-op clinic visit (estimated 3-4 weeks post-op)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start7 Feb 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort Study, without randomization, and evaluation of a single intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Cataldo, MD, University of Vermont
- Investigators
- Peter Cataldo, MD, Principal investigator, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200806
- Sponsor's protocol ID
- STUDY00000915
- Status last verified
- Oct 2022
- First submitted
- 10 Nov 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PubMed 27631771Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
PubMed 27400458Zin CS, Nazar NI, Rahman NSA, Ahmad WR, Rani NS, Ng KS. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naive patients in Malaysia: a retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e027203. doi: 10.1136/bmjopen-2018-027203.
PubMed 31270113Fields AC, Cavallaro PM, Correll DJ, Rubin MS, Sequist T, Khawaja A, Yao Y, Bordeianou LG, Bleday R. Predictors of Prolonged Opioid Use Following Colectomy. Dis Colon Rectum. 2019 Sep;62(9):1117-1123. doi: 10.1097/DCR.0000000000001429.
PubMed 31318765Alvarez MP, Foley KE, Zebley DM, Fassler SA. Comprehensive enhanced recovery pathway significantly reduces postoperative length of stay and opioid usage in elective laparoscopic colectomy. Surg Endosc. 2015 Sep;29(9):2506-11. doi: 10.1007/s00464-014-4006-8. Epub 2014 Dec 6.
PubMed 25480622Sobel DW, Cisu T, Barclay T, Pham A, Callas P, Sternberg K. A Retrospective Review Demonstrating the Feasibility of Discharging Patients Without Opioids After Ureteroscopy and Ureteral Stent Placement. J Endourol. 2018 Nov;32(11):1044-1049. doi: 10.1089/end.2018.0539. Epub 2018 Oct 23.
PubMed 30244594Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
PubMed 31154092
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
- ClinicalTrials.gov ID
- NCT05200806
- Acronym / sponsor ID
- STUDY00000915
- Conditions
- Analgesia, Post-Operative Pain, Breakthrough Pain, Colectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With this pilot investigation, the investigators aim to challenge the reliance on opiate analgesia following colon and rectal surgery. Narcotic misuse and abuse is a pressing public health concern, and reduction in prescription rates could help to mitigate this issue. The goal of this pilot study is to establish feasibility of sufficient post-operative pain control after colectomy using non-narcotic analgesics. The investigators hypothesize that patients will be able to manage their post-operative pain without narcotic intervention, while minimizing side effects and complications. This initial pilot study will provide proof-of-concept for a larger, randomized investigation on non-narcotic analgesia after colectomy.
Detailed description
Our primary objectives are:
- Determine the rate of patients needing rescue narcotics prescriptions for breakthrough postoperative pain after colectomy while on a non-narcotic postoperative protocol.
- Search for patterns pain and in timing of need for narcotic medication (e.g. in PACU, after intrathecal morphine wear off, etc.)
Secondary objectives:
- Measure patient satisfaction with pain management via survey administered at discharge and during the 30 days post-operation. This will include questions regarding medication side-effects.
- Determine factors that may affect patient need for narcotic pain medication, including complications (return to OR, anastomotic leak, prolonged ileus, post-operative hemorrhage), return of bowel function, side effects of medications, and length of hospital stay, which will be taken from patients' charts and surveys for analysis.
Procedures:
At their initial clinic visit for surgical scheduling, patients will be explained appropriate risks and benefits of participating in this pilot program. If interested, patients will choose to opt in to the protocol and consent to participate at this time. Pre-operatively, patients will adhere to the Enhanced Recovery After Surgery (ERAS) protocol in standard use at UVMMC for colectomy patients. This protocol includes administration of gabapentin (900 mg capsule), acetaminophen (1,000 mg tablet), dexamethasone (8 mg intravenously), granisetron (1 mg intravenously), and morphine (0.15 mg intrathecally). Appropriate medications will be administered at the discretion of the treating anesthesiologist during colectomy, but ketamine use will be encouraged if not contraindicated. Following the completion of colectomy, patients will only be given oral acetaminophen (650 mg, every 4 hours), gabapentin (300 mg, every 6 hours), methocarbamol (750mg, 4 times daily), and 5% lidocaine pat (every 12 hours, as needed), for analgesia from their stay in the PACU onwards. A one-time opioid rescue prescription for hydromorphone, morphine, or oxycodone will be available for breakthrough pain during their hospital stay. This differs from standard ERAS post-operative pain management, where hydromorphone, morphine, or oxycodone can be administered as needed. If a patient uses the one-time rescue dose, the covering physician will be notified and can then choose to order an appropriate narcotic regimen for the remainder of the patient's hospitalization. All patients will be discharged with a narcotics prescription that they can choose to fill. Throughout their hospitalization, patients will be asked to provide their pain level on the Visual Analog Scale (VAS) per typical protocol. At discharge, they will be given instructions for weaning pain medications at home. They will also be provided a medication diary, where they will record their pain levels, the time of administration of pain medications, and the name of the medications being administered. A patient satisfaction survey will be provided with the medication diary. The patient will be instructed to fill out the survey when they return home after discharge and to return the survey with their medication diary at their first follow up visit. An automated telephone call will occur daily for 1 week after discharge to remind the patient to record their pain level and medication use in the medication diary. At the patient's follow-up clinic visit, which occurs 3-4 weeks after discharge, the patient will bring their completed medication diary and first satisfaction survey. At this visit, a second patient satisfaction survey will be completed.
Outcome measures will be monitored through use of the rescue prescription while hospitalized, as well as self-reported surveys measuring post-operative pain, protocol side effects, and satisfaction of pain control, which will be given to the patients at discharge and at a follow-up clinic visit. Information on return of bowel function, length of hospital stay, and other medical complications will be gleaned from the patients' charts. Analysis of outcomes will be performed with the aid of a statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort Study, without randomization, and evaluation of a single intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Non-Narcotic ERAS Post-Operative Pain ManagementPre-Op Enhanced Recovery After Surgery (ERAS): Gabapentin (900mg capsule), Acetaminophen (1,000mg tablet), Dexamethasone (8mg IV), Granisetron (1mg IV), Morphine (0.15mg Intrathecal) Intraoperatively: Appropriate medications administered at discretion of the treating anesthesiologist during colectomy, with Ketamine use encouraged if not contraindicated. Post-Op (PACU, Onward during inpatient stay): Acetaminophen (Oral) (650mg, q4hrs), Gabapentin (300mg, q6hours), Methocarbamol (750mg, QID), 5% Lidocaine Patch (q12hrs PRN) One time rescue dose (Hydromorphone, Morphine, Oxycodone) available for breakthrough pain during hospital stay (differs from traditional ERAS protocol where medications can be administered as needed). If one-time rescue dose is needed, the covering physician will be notified and can choose to order an appropriate narcotic regimen for remainder of patient's hospitalization. All patients are discharged with a narcotics prescription that they can choose to fill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Undergoing elective abdominal colectomy
- Eligible for the Enhanced Recovery After Surgery (ERAS) protocol currently in place for colectomy patients at UVMMC
Key exclusion criteria (11 listed)
- allergy to any protocol medication
- emergent or urgent bowel surgery
- pre-operative plan for a stoma
- pre-operative diagnosis of rectal cancer (pre-operative diagnosis of rectosigmoid cancer is not necessarily excluded)
- neoadjuvant chemoradiation
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 |
|---|---|---|
| Non-Narcotic ERAS Post-Operative Pain ManagementAs described previously. | Other | Intervention |
Primary outcome
Failure Rate
Time frame: Until post-op clinic visit (estimated 3-4 weeks post-op)
Need for rescue narcotics for inadequately controlled pain as indicated in Electronic Medical Record (EMR).
1 secondary outcome
Patient Satisfaction
Time frame: Until post-op clinic visit (estimated 3-4 weeks post-op)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 27631771Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
- Background: PubMed 27400458Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
- Background: PubMed 31270113Zin CS, Nazar NI, Rahman NSA, Ahmad WR, Rani NS, Ng KS. Patterns of initial opioid prescription and its association with short-term and long-term use among opioid-naive patients in Malaysia: a retrospective cohort study. BMJ Open. 2019 Jul 2;9(7):e027203. doi: 10.1136/bmjopen-2018-027203.
- Background: PubMed 31318765Fields AC, Cavallaro PM, Correll DJ, Rubin MS, Sequist T, Khawaja A, Yao Y, Bordeianou LG, Bleday R. Predictors of Prolonged Opioid Use Following Colectomy. Dis Colon Rectum. 2019 Sep;62(9):1117-1123. doi: 10.1097/DCR.0000000000001429.
- Background: PubMed 25480622Alvarez MP, Foley KE, Zebley DM, Fassler SA. Comprehensive enhanced recovery pathway significantly reduces postoperative length of stay and opioid usage in elective laparoscopic colectomy. Surg Endosc. 2015 Sep;29(9):2506-11. doi: 10.1007/s00464-014-4006-8. Epub 2014 Dec 6.
- Background: PubMed 30244594Sobel DW, Cisu T, Barclay T, Pham A, Callas P, Sternberg K. A Retrospective Review Demonstrating the Feasibility of Discharging Patients Without Opioids After Ureteroscopy and Ureteral Stent Placement. J Endourol. 2018 Nov;32(11):1044-1049. doi: 10.1089/end.2018.0539. Epub 2018 Oct 23.
- Background: PubMed 31154092Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
- Individual participant dataSharing planned: No
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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.
OCTR Main Line contact
Peter Cataldo, MD principal investigator
University of Vermont Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-Narcotic ERAS Post-Operative Pain Management in people with Analgesia and Post-Operative Pain, run by University of Vermont 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Oct 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ethan D Jones, MPH (8026569437, ethan.d.jones@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure Rate (time frame: Until post-op clinic visit (estimated 3-4 weeks post-op)). 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 NCT05200806, which also lists 7 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 14 Oct 2022.