Post Operative Pain ControlPhase 4NCT02160301
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
A Phase 4 study testing Gabapentin, Acetaminophen and Celecoxib in people with Post Operative Pain Control, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain Control
- What is being tested?
- Gabapentin, Acetaminophen and Celecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2017to Dec 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bone fracture
- Isolated injury
- Requires operative intervention
Who cannot join
- pathological fractures
- inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- severe head injury
- polytrauma patients with multiple fractures or other injuries
- pregnancy
- open fractures
Show all 11Show fewer
- metabolic bone disease
- allergies or contraindications to the study medications, including sulfa medications.
- prior or current drug or alcohol dependence or abuse
- liver or kidney disease
- physician directed narcotic use
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Chapel Hill Hospital
Chapel Hill, North Carolina, 27514
About this study
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
Read the detailed description
Patients will be assessed for inclusion or exclusion during admission to the hospital or during evaluation in the clinic or emergency room for an isolated extremity fracture for which surgery is indicated. Once enrolled in the study and consent obtained, patients will be randomized into either the standard therapy group or the multimodal therapy group using permuted block randomization based on injury site. The sites of fracture are as follows:
- wrist/hand/forearm
- elbow/upper arm/shoulder
- acetabulum/pelvis
- foot/ankle
- patella/tibia (shaft, proximal)
- femur (proximal to distal)
The investigators have assumed that these distinct areas result in a similar amount of disability and pain as compared to the other sites. This is an attempt to mitigate the possible confounder of disproportionate numbers of more painful or more debilitating injuries falling in one study group compared to another.
Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices, relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low). If there is to be a delay between initial presentation and surgery, as is often the case for distal radius or ankle fractures, among others, multimodal patients will begin their therapy immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard therapy patients will be prescribed oxycodone alone, using the same parameters, with the ability to take acetaminophen on an as needed basis.
Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed when indicated, to confirm to the investigators standard of care. Patients will then undergo surgery with the investigators standardized anesthesia protocol as described in the protocol. Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively, multimodal patients will be given 1000mg acetaminophen three times daily for the duration of their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated to 200mg three times daily for 1 additional week. They will also receive an oxycodone prescription as described previously. Standard therapy patients will be given an oxycodone prescription alone with the advice to take tylenol on an as needed basis not to exceed 4000mg/day. No placebo medications will be used as this is an open label study.
Patients will be instructed to avoid all anti-inflammatory medications. All patients across groups will be given aspirin 81mg for deep vein thrombosis prophylaxis if they suffered a lower extremity fracture. Should a patient require an alternative deep vein thrombosis prophylaxis regimen due to an allergy to aspirin or a personal history of deep vein thromboses, low molecular weight heparin will be used.
Patients will be given a diary to record their daily narcotic use, daily minimum, maximum and average pain scores using a visual analog scale and any side effects. Patients will be provided the contact information of the attending surgeon's nurse to report any serious allergies or adverse effects of the study medications. A case by case decision will be made to either continue the protocol or to drop the patient from the study and make needed medications changes.
Patients will be followed at defined time points after surgery including, 2 wks, 6wks, 3mo and 6mo.
At their 2 wk follow up visit they will fill out the Short Musculoskeletal Function Assessment for their preoperative functional state as well as the American Pain Society Patient Satisfaction Questionnaire. These will again be filled out at their 3 and 6 month visits. Union will be assessed at their 3 and 6 month visits by a third party, blinded observed. It will be defined as three cortices of bridging callus on 2 orthogonal views. Once fracture union occurs or nonunion is identified control patients will be allowed to use non steroidal anti-inflammatories as needed. Time to return to work/normal activity, total narcotic usage and duration of narcotic use will also be recorded.
- Conditions
- Post Operative Pain Control
- Being tested
- Gabapentin, Acetaminophen, Celecoxib, Dexamethasone, Oxycodone
- Keywords
- pain, postoperative, multimodal, satisfaction, narcotic
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
PO
AcetaminophenDrug
Also called Tylenol, Acephen, Cetafen, Mapap
PO
AcetaminophenDrug
Also called Ofirmev
IV
CelecoxibDrug
Also called Celebrex
PO
DexamethasoneDrug
Also called Baycadron
IV
OxycodoneDrug
Also called Roxicodone
PO
| Study group | Role | What they receive |
|---|---|---|
| Multimodal pain control | Experimental | Oxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op. Receives: Drug: Gabapentin; Drug: Acetaminophen; Drug: Celecoxib; Drug: Dexamethasone; Drug: Oxycodone |
| Standard pain control | Active comparator | Oxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn. Receives: Drug: Acetaminophen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.
Measured: 6 months
Narcotic Use
Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.
Measured: 2 months
Patient Satisfaction
Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).
Measured: 3 months
Secondary outcomes (3)
Patient function
Measurement of patient function using the Short Musculoskeletal Functional Assessment questionnaire.
Measured: 6 months
Fracture Union
Binary determination of fracture union (yes or no) during the 6 month duration of the study.
Measured: 6 months
Adverse events
Measurement of the rate of adverse events post operatively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startNov 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Insufficient infrastructure/funding for enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain ControlStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert F Ostrum, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160301
- Sponsor's protocol ID
- 13-2669
- Status last verified
- May 2017
- First submitted
- 6 Jun 2014
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
PubMed 23302898Maheshwari AV, Boutary M, Yun AG, Sirianni LE, Dorr LD. Multimodal analgesia without routine parenteral narcotics for total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:231-8. doi: 10.1097/01.blo.0000246545.72445.c4.
PubMed 17031312Kashefi P, Honarmand A, Safavi M. Effects of preemptive analgesia with celecoxib or acetaminophen on postoperative pain relief following lower extremity orthopedic surgery. Adv Biomed Res. 2012;1:66. doi: 10.4103/2277-9175.100197. Epub 2012 Aug 28.
PubMed 23459777Panah Khahi M, Yaghooti AA, Marashi SH, Nadjafi A. Effect of pre-emptive gabapentin on postoperative pain following lower extremity orthopaedic surgery under spinal anaesthesia. Singapore Med J. 2011 Dec;52(12):879-82.
PubMed 22159930Montazeri K, Kashefi P, Honarmand A. Pre-emptive gabapentin significantly reduces postoperative pain and morphine demand following lower extremity orthopaedic surgery. Singapore Med J. 2007 Aug;48(8):748-51.
PubMed 17657384Ho KY, Gan TJ, Habib AS. Gabapentin and postoperative pain--a systematic review of randomized controlled trials. Pain. 2006 Dec 15;126(1-3):91-101. doi: 10.1016/j.pain.2006.06.018. Epub 2006 Jul 18.
PubMed 16846695Yadeau JT, Paroli L, Kahn RL, Jules-Elysee KM, Lasala VR, Liu SS, Lin E, Powell K, Buschiazzo VL, Wukovits B, Roberts MM, Levine DS. Addition of pregabalin to multimodal analgesic therapy following ankle surgery: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2012 May-Jun;37(3):302-7. doi: 10.1097/AAP.0b013e31824c6846.
PubMed 22476240Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.
PubMed 23567482Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
PubMed 20375829Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.
PubMed 19258965Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
PubMed 20957469Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.
PubMed 22732860VanDenKerkhof EG, Hopman WM, Goldstein DH, Wilson RA, Towheed TE, Lam M, Harrison MB, Reitsma ML, Johnston SL, Medd JD, Gilron I. Impact of perioperative pain intensity, pain qualities, and opioid use on chronic pain after surgery: a prospective cohort study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):19-27. doi: 10.1097/AAP.0b013e318237516e.
PubMed 22157741Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas F, Whyte RI, Donington JS, Cannon WB, Mackey SC. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012 Sep;115(3):694-702. doi: 10.1213/ANE.0b013e31825c049f. Epub 2012 Jun 22.
PubMed 22729963Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
PubMed 23850410
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients
- ClinicalTrials.gov ID
- NCT02160301
- Acronym / sponsor ID
- 13-2669
- Conditions
- Post Operative Pain Control
- Keywords
- pain, postoperative, multimodal, satisfaction, narcotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient infrastructure/funding for enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- 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.
The study is a prospective, randomized, open-label comparison of a multimodal regimen and a standard, narcotic-based regimen for postoperative pain control in patients undergoing surgery for an operatively indicated, isolated extremity fracture. The investigators will be measuring pain levels, narcotic use, patient satisfaction, patient reported function, adverse events and fracture union. The investigators hypothesize that this multimodal regimen will lead to improved pain, less narcotic use and improved satisfaction as compared to the standard regimen.
Detailed description
Patients will be assessed for inclusion or exclusion during admission to the hospital or during evaluation in the clinic or emergency room for an isolated extremity fracture for which surgery is indicated. Once enrolled in the study and consent obtained, patients will be randomized into either the standard therapy group or the multimodal therapy group using permuted block randomization based on injury site. The sites of fracture are as follows:
- wrist/hand/forearm
- elbow/upper arm/shoulder
- acetabulum/pelvis
- foot/ankle
- patella/tibia (shaft, proximal)
- femur (proximal to distal)
The investigators have assumed that these distinct areas result in a similar amount of disability and pain as compared to the other sites. This is an attempt to mitigate the possible confounder of disproportionate numbers of more painful or more debilitating injuries falling in one study group compared to another.
Pre-operatively, patient demographic data will be recording including age, gender, BMI, hand dominance, occupation, use of tobacco/alcohol/illicit drugs, use of assistive devices, relevant comorbidities (i.e., diabetes), site of injury, mechanism and energy (high or low). If there is to be a delay between initial presentation and surgery, as is often the case for distal radius or ankle fractures, among others, multimodal patients will begin their therapy immediately after evaluation. Thus, they will be started on scheduled 1000mg acetaminophen and 100mg gabapentin both three times daily. They will also be provided an 5mg oxycodone prescription with instructions to take 1-3 tablets every 4 hours as needed for pain. Standard therapy patients will be prescribed oxycodone alone, using the same parameters, with the ability to take acetaminophen on an as needed basis.
Pre-operatively, multimodal patients will receive 1000mg IV acetaminophen, 100mg PO gabapentin and 400mg PO celecoxib. All patients will have a peripheral nerve block placed when indicated, to confirm to the investigators standard of care. Patients will then undergo surgery with the investigators standardized anesthesia protocol as described in the protocol. Intraoperatively, multimodal patients will receive 8mg of IV dexamethasone. Post-operatively, multimodal patients will be given 1000mg acetaminophen three times daily for the duration of their narcotic use and 100mg Gabapentin three times daily for 1 week, which will be titrated to 200mg three times daily for 1 additional week. They will also receive an oxycodone prescription as described previously. Standard therapy patients will be given an oxycodone prescription alone with the advice to take tylenol on an as needed basis not to exceed 4000mg/day. No placebo medications will be used as this is an open label study.
Patients will be instructed to avoid all anti-inflammatory medications. All patients across groups will be given aspirin 81mg for deep vein thrombosis prophylaxis if they suffered a lower extremity fracture. Should a patient require an alternative deep vein thrombosis prophylaxis regimen due to an allergy to aspirin or a personal history of deep vein thromboses, low molecular weight heparin will be used.
Patients will be given a diary to record their daily narcotic use, daily minimum, maximum and average pain scores using a visual analog scale and any side effects. Patients will be provided the contact information of the attending surgeon's nurse to report any serious allergies or adverse effects of the study medications. A case by case decision will be made to either continue the protocol or to drop the patient from the study and make needed medications changes.
Patients will be followed at defined time points after surgery including, 2 wks, 6wks, 3mo and 6mo.
At their 2 wk follow up visit they will fill out the Short Musculoskeletal Function Assessment for their preoperative functional state as well as the American Pain Society Patient Satisfaction Questionnaire. These will again be filled out at their 3 and 6 month visits. Union will be assessed at their 3 and 6 month visits by a third party, blinded observed. It will be defined as three cortices of bridging callus on 2 orthogonal views. Once fracture union occurs or nonunion is identified control patients will be allowed to use non steroidal anti-inflammatories as needed. Time to return to work/normal activity, total narcotic usage and duration of narcotic use will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal pain control | Experimental | Drug: Gabapentin, Drug: Acetaminophen, Drug: Celecoxib, Drug: Dexamethasone, Drug: OxycodoneOxycodone 5-15mg PO q4hrs prn pre- and post-op, Acetaminophen 1000mg IV once pre-op, Acetaminophen 1000mg PO q8hrs pre-op and x2 weeks post op, prn thereafter, Gabapentin 100mg/200mg PO a8hrs pre-op and x2 weeks post op, Dexamethasone 8mg IV once intra-op, Celecoxib 400mg PO once pre-op. |
| Standard pain control | Active comparator | Drug: Acetaminophen, Drug: OxycodoneOxycodone 5-15mg PO q4hrs prn, Acetaminophen 1000mg PO q8hrs prn. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bone fracture
- Isolated injury
- Requires operative intervention
Key exclusion criteria (11 listed)
- pathological fractures
- inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- severe head injury
- polytrauma patients with multiple fractures or other injuries
- pregnancy
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 |
|---|---|---|
| GabapentinAlso: NeurontinPO | Drug | Multimodal pain control |
| AcetaminophenAlso: Tylenol, Acephen, Cetafen, MapapPO | Drug | Multimodal pain control, Standard pain control |
| AcetaminophenAlso: OfirmevIV | Drug | Multimodal pain control |
| CelecoxibAlso: CelebrexPO | Drug | Multimodal pain control |
| DexamethasoneAlso: BaycadronIV | Drug | Multimodal pain control |
| OxycodoneAlso: RoxicodonePO | Drug | Multimodal pain control, Standard pain control |
Primary outcome
Pain
Time frame: 6 months
VAS score for pain control, daily for two weeks post op and at all follow up visits for 6 months.
Narcotic Use
Time frame: 2 months
Measurement of both daily narcotic use in milligrams as well as the duration of narcotic treatment in days.
Patient Satisfaction
Time frame: 3 months
Measurement of patient satisfaction with pain control regimen using the American Pain Society's Patient Outcome Questionnaire (APS-POQ).
3 secondary outcomes
Patient function
Time frame: 6 months
Fracture Union
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Background: PubMed 23302898Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.
- Background: PubMed 17031312Maheshwari AV, Boutary M, Yun AG, Sirianni LE, Dorr LD. Multimodal analgesia without routine parenteral narcotics for total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:231-8. doi: 10.1097/01.blo.0000246545.72445.c4.
- Background: PubMed 23459777Kashefi P, Honarmand A, Safavi M. Effects of preemptive analgesia with celecoxib or acetaminophen on postoperative pain relief following lower extremity orthopedic surgery. Adv Biomed Res. 2012;1:66. doi: 10.4103/2277-9175.100197. Epub 2012 Aug 28.
- Background: PubMed 22159930Panah Khahi M, Yaghooti AA, Marashi SH, Nadjafi A. Effect of pre-emptive gabapentin on postoperative pain following lower extremity orthopaedic surgery under spinal anaesthesia. Singapore Med J. 2011 Dec;52(12):879-82.
- Background: PubMed 17657384Montazeri K, Kashefi P, Honarmand A. Pre-emptive gabapentin significantly reduces postoperative pain and morphine demand following lower extremity orthopaedic surgery. Singapore Med J. 2007 Aug;48(8):748-51.
- Background: PubMed 16846695Ho KY, Gan TJ, Habib AS. Gabapentin and postoperative pain--a systematic review of randomized controlled trials. Pain. 2006 Dec 15;126(1-3):91-101. doi: 10.1016/j.pain.2006.06.018. Epub 2006 Jul 18.
- Background: PubMed 22476240Yadeau JT, Paroli L, Kahn RL, Jules-Elysee KM, Lasala VR, Liu SS, Lin E, Powell K, Buschiazzo VL, Wukovits B, Roberts MM, Levine DS. Addition of pregabalin to multimodal analgesic therapy following ankle surgery: a randomized double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2012 May-Jun;37(3):302-7. doi: 10.1097/AAP.0b013e31824c6846.
- Background: PubMed 23567482Khalili G, Janghorbani M, Saryazdi H, Emaminejad A. Effect of preemptive and preventive acetaminophen on postoperative pain score: a randomized, double-blind trial of patients undergoing lower extremity surgery. J Clin Anesth. 2013 May;25(3):188-92. doi: 10.1016/j.jclinane.2012.09.004. Epub 2013 Apr 6.
- Background: PubMed 20375829Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
- Background: PubMed 19258965Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.
- Background: PubMed 20957469Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19.
- Background: PubMed 22732860Goldstein RY, Montero N, Jain SK, Egol KA, Tejwani NC. Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study. J Orthop Trauma. 2012 Oct;26(10):557-61. doi: 10.1097/BOT.0b013e3182638b25.
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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.
Robert F Ostrum, MD principal investigator
UNC Chapel Hill
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, Acetaminophen and Celecoxib in people with Post Operative Pain Control, run by University of North Carolina, Chapel Hill 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: withdrawn, as of the sponsor's last update on 19 May 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: 6 months). The study lists 3 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 NCT02160301, 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 19 May 2017.