PainPhase 4NCT01868425
ACL Repair and Multimodal Analgesia
A Phase 4 study testing multimodal:acetaminophen, gabapentin, ketamine, bupivacaine in people with Pain, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- multimodal:acetaminophen, gabapentin, ketamine, bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2017
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
- American Society of Anesthesiologists (ASA) physical status 1-3
- BMI of < 40 kg/m2
- Consents to general anesthesia and pre-operative femoral nerve block for case
Who cannot join
- Any contraindication to a femoral nerve block
- Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
- Peripheral or central nervous system disease
- Renal or hepatic impairment
- History of opioid dependence or current regular narcotic use
- Significant psychiatric disease
Show all 11Show fewer
- Pregnancy or lactation (by verbal report)
- Seizure Disorder
- History of post-operative nausea and vomiting
- Latex allergy
- Clinically significant cardiac or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.
- Conditions
- Pain
- Being tested
- multimodal:acetaminophen, gabapentin, ketamine, bupivacaine, placebo pills and injectables
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal:acetaminophen, gabapentin, ketamine, bupivacaineDrug
acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
placebo pills and injectablesDrug
receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds
| Study group | Role | What they receive |
|---|---|---|
| multimodal:acetaminophen, gabapentin, ketamine, bupivacaine | Experimental | aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane Receives: Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaine |
| placebo pills and injectables | Placebo comparator | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane Receives: Drug: placebo pills and injectables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption in the Immediate Postoperative Period
This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours.
Measured: Up to 10 hours
Secondary outcomes (12)
Pain Scores During Recovery
Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain.
Measured: up to 24 hours postoperatively
Number of Participants Who Received Medication for Nausea
Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.
Measured: Up to 24 hours following surgery
Post-Operative Incidence of Nausea
Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.
Measured: Up to 24 hours following surgery
Post-Operative Nausea Scores
Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible).
Measured: Up to 24 hours following surgery
Incidence of Post-Operative Pruritus
Pruritus in recovery and through the first 24 hours post-op.
Measured: Up to 24 hours following surgery
Post-Operative Pruritis Score
Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call.
Measured: Up to 24 hours following surgery
Sedation Scale
Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake.
Measured: Up to 24 hours following surgery
Impact of Block Characteristics on Pain Control
Measured: Up to 24 hours following surgery
Intraoperative Medication Use: Ketorolac and Lidocaine
All participants received standard induction medications.
Measured: From induction until arrival in post anesthesia care unit.
Intraoperative Medication Use: Fentanyl
All participants received standard induction medications.
Measured: From induction until arrival in post anesthesia care unit.
Number of Participants With Complications From the Procedure
Measured: Up to 24 hours following surgery
Time to Discharge
Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).
Measured: Up to 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2017
- Study completionDec 2017
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.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Shepler, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868425
- Sponsor's protocol ID
- 2012-0538
- Other IDs
- 2017-0712, A530900, SMPH/ANESTHESIOLOGY
- Status last verified
- Mar 2020
- First submitted
- 13 May 2013
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Repair and Multimodal Analgesia
- ClinicalTrials.gov ID
- NCT01868425
- Acronym / sponsor ID
- 2012-0538
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multimodal:acetaminophen, gabapentin, ketamine, bupivacaine | Experimental | Drug: multimodal:acetaminophen, gabapentin, ketamine, bupivacaineaggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
| placebo pills and injectables | Placebo comparator | Drug: placebo pills and injectablesstandard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
Key exclusion criteria (11 listed)
- Any contraindication to a femoral nerve block
- Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
- Peripheral or central nervous system disease
- Renal or hepatic impairment
- History of opioid dependence or current regular narcotic use
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 |
|---|---|---|
| multimodal:acetaminophen, gabapentin, ketamine, bupivacaineacetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane | Drug | multimodal:acetaminophen, gabapentin, ketamine, bupivacaine |
| placebo pills and injectablesreceives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds | Drug | placebo pills and injectables |
Primary outcome
Opioid Consumption in the Immediate Postoperative Period
Time frame: Up to 10 hours
This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours.
12 secondary outcomes
Pain Scores During Recovery
Time frame: up to 24 hours postoperatively
Number of Participants Who Received Medication for Nausea
Time frame: Up to 24 hours following surgery
Post-Operative Incidence of Nausea
Time frame: Up to 24 hours following surgery
Post-Operative Nausea Scores
Time frame: Up to 24 hours following surgery
Incidence of Post-Operative Pruritus
Time frame: Up to 24 hours following surgery
Post-Operative Pruritis Score
Time frame: Up to 24 hours following surgery
Sedation Scale
Time frame: Up to 24 hours following surgery
Impact of Block Characteristics on Pain Control
Time frame: Up to 24 hours following surgery
Intraoperative Medication Use: Ketorolac and Lidocaine
Time frame: From induction until arrival in post anesthesia care unit.
Intraoperative Medication Use: Fentanyl
Time frame: From induction until arrival in post anesthesia care unit.
Number of Participants With Complications From the Procedure
Time frame: Up to 24 hours following surgery
Time to Discharge
Time frame: Up to 24 hours following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John A Shepler principal investigator
University of Wisconsin, Madison
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 multimodal:acetaminophen, gabapentin, ketamine, bupivacaine in people with Pain, run by University of Wisconsin, Madison 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 4 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: finished, as of the sponsor's last update on 30 Mar 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. Some participants in this study may receive a placebo. 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 16 Mar 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?
Opioid Consumption in the Immediate Postoperative Period (time frame: Up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2020.