Opioid UsePhase 4NCT03540030
Opioid-Free Shoulder Arthroplasty
A Phase 4 study testing Gabapentin, Celecoxib and toradol in people with Opioid Use and Shoulder Osteoarthritis, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
Purpose of Study: To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Opioid Use, Shoulder Osteoarthritis, Avascular Necrosis
- What is being tested?
- Gabapentin, Celecoxib and toradol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2019
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
- Age greater than or equal to 50.
Who cannot join
- Revision total shoulder arthroplasty
- Chronic opioid therapy - per investigator discretion
- Liver or renal insufficiency - per investigator discretion
- Arthroplasty for fracture
- Sickle cell disease
- Workers compensation
Show all 9Show fewer
- Inability to receive block
- Intervention Arm Only: Creatinine clearance less than 30 mL/min
- Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications (NSAIDs).
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
Purpose of Study:
To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
Read the detailed description
Background and Significance:
Opioid-based analgesia has been a cornerstone of patient care in the setting of acute pain for the last century and has undergone logarithmic increase over the past twenty years. Unfortunately, the rise in utilization has brought with it a rise in opioid-induced side effects. These include constipation, nausea/vomiting, hyperalgesia, delirium, addiction/withdrawal (with 67% of those prescribed a long-term opioid program still on opioids at an average of 4.8 years of follow-up), and in some cases even respiratory depression/death. Patient expectations of opioid-based pain medication has driven a rapid rise in outpatient opioid prescriptions including both short and long-acting opioids. These prescriptions have in turn become a source of significant mortality in the United States, with nearly 20,000 deaths due to opioid overdose in 2014 alone.
There have been momentous efforts made in identifying synergistic compounds to use for acute pain management in the perioperative time period to begin to minimize the opioid requirement for pain control. These studies have focused on nerve modulation with gabapentinoids, intravenous and local administration of sodium-channel blockers such as lidocaine and bupivacaine, and even increased interest in non-steroidal anti-inflammatories and acetaminophen. At this time, no study has looked at the possibility of utilizing a multi-modal acute post-surgical pain control pathway that did not include some form of opioid medication for the general population.
Arthroplasty continues to be a dominant procedure in the orthopaedic armamentarium and accounts for well over a million surgeries done in the United States per year. With the ability to utilize targeted nerve blocks by anesthesia, and the increasing data showing efficacy of multi-modal therapy for acute pain, we propose a patient care pathway that is completely free of all opioid-based medications. From the time that patients are checked in until the time the patient follows up in clinic, they will utilize a pathway designed to eliminate pain and opioid-related side effects following shoulder arthroplasty. Our hope is that a well-designed pathway for total shoulder arthroplasty can quickly be modeled for other surgical procedures in an attempt to minimize the negative effects of opioid utilization both acutely and on a societal level.
- Conditions
- Opioid Use, Shoulder Osteoarthritis, Avascular Necrosis, Rotator Cuff Tear, Arthritis;Inflammatory
- Being tested
- Gabapentin, Celecoxib, toradol, acetaminophen, regional block
- Keywords
- Primary Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- Medical subject headings
- Osteonecrosis, Rotator Cuff Injuries, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
CelecoxibDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
toradolDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
acetaminophenDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
regional blockDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
propofolDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
IV lidocaineDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
rocuroniumDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
vecuroniumDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
sevofluraneDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
desfluraneDrug
opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
| Study group | Role | What they receive |
|---|---|---|
| Observational | No intervention | The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. |
| Non-Opioid Intervention | Active comparator | Oral dose of both gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without the aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but should include one dose of IV acetaminophen during the procedure. Anesthetic modalities will include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). As needed medications will include both oral and IV acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. Receives: Drug: Gabapentin; Drug: Celecoxib; Drug: toradol; Drug: acetaminophen; Drug: regional block; Drug: propofol; Drug: IV lidocaine; Drug: rocuronium; Drug: vecuronium; Drug: sevoflurane; Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Op Pain
Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)
Measured: 24 hours
Secondary outcomes (15)
Additional Post Op Pain
post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain)
Measured: 6hrs, 12hrs, 2weeks, 2 months
Nausea
rate of nausea
Measured: 2 Weeks
Constipation
rate of constipation
Measured: 2 Weeks
Falls
rate of falls
Measured: 2 Weeks
Morphine Use
Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge.
Measured: In-hospital Stay
Pain Satisfaction
Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.
Measured: 2 Weeks
ASES
American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score.
Measured: 2 Weeks
Simple Shoulder Test
Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.
Measured: 2 Weeks
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
Measured: 2 Weeks
Nausea
rate of nausea
Measured: 2 Months
Constipation
rate of constipation
Measured: 2 Months
Falls
rate of falls
Measured: 2 Months
Pain Satisfaction
Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes.
Measured: 2 Months
Simple Shoulder Test
Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score.
Measured: 2 Months
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study startSep 2016
- Primary completionMar 2019
- Study completionJun 2019
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 (27)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540030
- Sponsor's protocol ID
- Pro00021833
- Status last verified
- Oct 2020
- First submitted
- 8 May 2018
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
PubMed 24829420Lee HJ, Yeomans DC. Opioid induced hyperalgesia in anesthetic settings. Korean J Anesthesiol. 2014 Nov;67(5):299-304. doi: 10.4097/kjae.2014.67.5.299. Epub 2014 Nov 26.
PubMed 25473457McKeown JL. Pain Management Issues for the Geriatric Surgical Patient. Anesthesiol Clin. 2015 Sep;33(3):563-76. doi: 10.1016/j.anclin.2015.05.010. Epub 2015 Jul 3.
PubMed 26315638Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. doi: 10.1177/0310057X1404200504.
PubMed 25233168Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.
PubMed 16636030Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A systematic review and meta-regression analysis of prophylactic gabapentin for postoperative pain. Anaesthesia. 2015 Oct;70(10):1186-204. doi: 10.1111/anae.13179. Epub 2015 Aug 24.
PubMed 26300519Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.
PubMed 25209095Banerjee P, Rogers BA. Systematic review of high-volume multimodal wound infiltration in total knee arthroplasty. Orthopedics. 2014 Jun;37(6):403-12. doi: 10.3928/01477447-20140528-07.
PubMed 24972430Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220.
PubMed 24996539Skolnik A, Gan TJ. New formulations of bupivacaine for the treatment of postoperative pain: liposomal bupivacaine and SABER-Bupivacaine. Expert Opin Pharmacother. 2014 Aug;15(11):1535-42. doi: 10.1517/14656566.2014.930436. Epub 2014 Jul 3.
PubMed 24992382Kazerooni R, Tran MH. Evaluation of Celecoxib Addition to Pain Protocol After Total Hip and Knee Arthroplasty Stratified by Opioid Tolerance. Clin J Pain. 2015 Oct;31(10):903-8. doi: 10.1097/AJP.0000000000000178.
PubMed 25380221Khan JS, Margarido C, Devereaux PJ, Clarke H, McLellan A, Choi S. Preoperative celecoxib in noncardiac surgery: A systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2016 Mar;33(3):204-14. doi: 10.1097/EJA.0000000000000346.
PubMed 26760402Koh W, Nguyen KP, Jahr JS. Intravenous non-opioid analgesia for peri- and postoperative pain management: a scientific review of intravenous acetaminophen and ibuprofen. Korean J Anesthesiol. 2015 Feb;68(1):3-12. doi: 10.4097/kjae.2015.68.1.3. Epub 2015 Jan 28.
PubMed 25664148Nir RR, Nahman-Averbuch H, Moont R, Sprecher E, Yarnitsky D. Preoperative preemptive drug administration for acute postoperative pain: A systematic review and meta-analysis. Eur J Pain. 2016 Aug;20(7):1025-43. doi: 10.1002/ejp.842. Epub 2016 Mar 15.
PubMed 26991963Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10.
PubMed 25436192
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT03540030
- Acronym / sponsor ID
- Pro00021833
- Conditions
- Opioid Use, Shoulder Osteoarthritis, Avascular Necrosis, Rotator Cuff Tear, Arthritis;Inflammatory
- Keywords
- Primary Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of Study:
To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
Detailed description
Background and Significance:
Opioid-based analgesia has been a cornerstone of patient care in the setting of acute pain for the last century and has undergone logarithmic increase over the past twenty years. Unfortunately, the rise in utilization has brought with it a rise in opioid-induced side effects. These include constipation, nausea/vomiting, hyperalgesia, delirium, addiction/withdrawal (with 67% of those prescribed a long-term opioid program still on opioids at an average of 4.8 years of follow-up), and in some cases even respiratory depression/death. Patient expectations of opioid-based pain medication has driven a rapid rise in outpatient opioid prescriptions including both short and long-acting opioids. These prescriptions have in turn become a source of significant mortality in the United States, with nearly 20,000 deaths due to opioid overdose in 2014 alone.
There have been momentous efforts made in identifying synergistic compounds to use for acute pain management in the perioperative time period to begin to minimize the opioid requirement for pain control. These studies have focused on nerve modulation with gabapentinoids, intravenous and local administration of sodium-channel blockers such as lidocaine and bupivacaine, and even increased interest in non-steroidal anti-inflammatories and acetaminophen. At this time, no study has looked at the possibility of utilizing a multi-modal acute post-surgical pain control pathway that did not include some form of opioid medication for the general population.
Arthroplasty continues to be a dominant procedure in the orthopaedic armamentarium and accounts for well over a million surgeries done in the United States per year. With the ability to utilize targeted nerve blocks by anesthesia, and the increasing data showing efficacy of multi-modal therapy for acute pain, we propose a patient care pathway that is completely free of all opioid-based medications. From the time that patients are checked in until the time the patient follows up in clinic, they will utilize a pathway designed to eliminate pain and opioid-related side effects following shoulder arthroplasty. Our hope is that a well-designed pathway for total shoulder arthroplasty can quickly be modeled for other surgical procedures in an attempt to minimize the negative effects of opioid utilization both acutely and on a societal level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational | No intervention | –The observational treatment group will not have any changes from your surgeon's normal pain management process. Anesthesia will be utilized in a routine fashion with all routine perioperative medications. You will be discharged on routine postoperative medications including opioids, NSAIDS, and any other modalities typically used by the treating surgeon. |
| Non-Opioid Intervention | Active comparator | Drug: Gabapentin, Drug: Celecoxib, Drug: toradol, Drug: acetaminophen, Drug: regional block, Drug: propofol, Drug: IV lidocaine, Drug: rocuronium, Drug: vecuronium, Drug: sevoflurane, Drug: desfluraneOral dose of both gabapentin and celecoxib (toradol if sulfa allergy) in the preop area. US-guided interscalene regional block without the aid of opioid co-medication. Intra-op management by anesthesia with non-opioid modalities but should include one dose of IV acetaminophen during the procedure. Anesthetic modalities will include, but not limited to, regional block, propofol, IV lidocaine, rocuronium/vecuronium, and sevoflurane/desflurane. If the attending anesthesiologist deems it necessary to dose with opioids during procedure, it will be recorded and reported. Liposomal bupivacaine will be injected into the peri-articular soft tissues as an adjunct to the block. Post Op, cryotherapy, gabapentin, toradol. Toradol will transition to celecoxib for the duration of the hospitalization (or meloxicam for patients with sulfa allergy). As needed medications will include both oral and IV acetaminophen, as well as up to an additional 15mg of toradol per 6hr, depending on Cr clearance. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
- Age greater than or equal to 50.
Key exclusion criteria (9 listed)
- Revision total shoulder arthroplasty
- Chronic opioid therapy - per investigator discretion
- Liver or renal insufficiency - per investigator discretion
- Arthroplasty for fracture
- Sickle cell disease
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 |
|---|---|---|
| Gabapentinopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| Celecoxibopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| toradolopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| acetaminophenopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| regional blockopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| propofolopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| IV lidocaineopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| rocuroniumopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| vecuroniumopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| sevofluraneopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
| desfluraneopioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment | Drug | Non-Opioid Intervention |
Primary outcome
Post Op Pain
Time frame: 24 hours
Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain)
15 secondary outcomes
Additional Post Op Pain
Time frame: 6hrs, 12hrs, 2weeks, 2 months
Nausea
Time frame: 2 Weeks
Constipation
Time frame: 2 Weeks
Falls
Time frame: 2 Weeks
Morphine Use
Time frame: In-hospital Stay
Pain Satisfaction
Time frame: 2 Weeks
ASES
Time frame: 2 Weeks
Simple Shoulder Test
Time frame: 2 Weeks
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
Time frame: 2 Weeks
Nausea
Time frame: 2 Months
Constipation
Time frame: 2 Months
Falls
Time frame: 2 Months
Pain Satisfaction
Time frame: 2 Months
Simple Shoulder Test
Time frame: 2 Months
Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
Time frame: 2 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24829420Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
- Background: PubMed 25473457Lee HJ, Yeomans DC. Opioid induced hyperalgesia in anesthetic settings. Korean J Anesthesiol. 2014 Nov;67(5):299-304. doi: 10.4097/kjae.2014.67.5.299. Epub 2014 Nov 26.
- Background: PubMed 26315638McKeown JL. Pain Management Issues for the Geriatric Surgical Patient. Anesthesiol Clin. 2015 Sep;33(3):563-76. doi: 10.1016/j.anclin.2015.05.010. Epub 2015 Jul 3.
- Background: PubMed 25233168Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. doi: 10.1177/0310057X1404200504.
- Background: PubMed 16636030Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.
- Background: PubMed 26300519Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A systematic review and meta-regression analysis of prophylactic gabapentin for postoperative pain. Anaesthesia. 2015 Oct;70(10):1186-204. doi: 10.1111/anae.13179. Epub 2015 Aug 24.
- Background: PubMed 25209095Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.
- Background: PubMed 24972430Banerjee P, Rogers BA. Systematic review of high-volume multimodal wound infiltration in total knee arthroplasty. Orthopedics. 2014 Jun;37(6):403-12. doi: 10.3928/01477447-20140528-07.
- Background: PubMed 24996539Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220.
- Background: PubMed 24992382Skolnik A, Gan TJ. New formulations of bupivacaine for the treatment of postoperative pain: liposomal bupivacaine and SABER-Bupivacaine. Expert Opin Pharmacother. 2014 Aug;15(11):1535-42. doi: 10.1517/14656566.2014.930436. Epub 2014 Jul 3.
- Background: PubMed 25380221Kazerooni R, Tran MH. Evaluation of Celecoxib Addition to Pain Protocol After Total Hip and Knee Arthroplasty Stratified by Opioid Tolerance. Clin J Pain. 2015 Oct;31(10):903-8. doi: 10.1097/AJP.0000000000000178.
- Background: PubMed 26760402Khan JS, Margarido C, Devereaux PJ, Clarke H, McLellan A, Choi S. Preoperative celecoxib in noncardiac surgery: A systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2016 Mar;33(3):204-14. doi: 10.1097/EJA.0000000000000346.
- Individual participant dataSharing planned: No
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Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gabapentin, Celecoxib and toradol in people with Opioid Use and Shoulder Osteoarthritis, run by OrthoCarolina Research Institute, Inc. 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 9 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 14 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2020). 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?
Post Op Pain (time frame: 24 hours). 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 NCT03540030, which also lists 27 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 2020.