Shoulder ArthroscopyPhase 4NCT01112878
Oral Clonidine & Gabapentin: Improving Recovery and Pain Management After Outpatient With Major Orthopedic Surgery
A Phase 4 study testing Sugar pill, Gabapentin and Clonidine in people with Shoulder Arthroscopy and Knee Arthroscopy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving medications clonidine and gabapentin to see if they decrease the amount of opioid pain medications needed after surgery, thereby reducing opioid-related side effects, and time required to return to normal activities of daily… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Arthroscopy, Knee Arthroscopy
- What is being tested?
- Sugar pill, Gabapentin and Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo arthroscopic joint surgery
- Willingness and ability to sign an informed consent document
- No allergies to clonidine, gabapentin, anesthetic or analgesic medications
- 18 - 80 years of age
- American Society of Anesthesiologists (ASA) Class I - III adults of either sex
- Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test
Who cannot join
- Patients with known allergy, hypersensitivity or contraindications to clonidine, gabapentin, anesthetic or analgesic medications
- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
- Patients with chronic hypertension or pain syndromes receiving clonidine or gabapentin, respectively.
- Pregnant or lactating women
- Subjects with a history of alcohol or drug abuse within the past 3 months
- Patients taking any analgesic medications within 48 hours prior to the surgery
Show all 9Show fewer
- Any other conditions or use of any medication which may interfere with the conduct of the study
- Non-English speakers
- Patients greater than 80 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Randomized, Double-Blinded, Placebo-controlled Study to Evaluate the Analgesic Efficacy of Oral Clonidine and Gabapentin as Part of a Multi-modal Analgesic Regimen for Preventing Pain After Arthroscopic Shoulder or Knee Surgery
The purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving medications clonidine and gabapentin to see if they decrease the amount of opioid pain medications needed after surgery, thereby reducing opioid-related side effects, and time required to return to normal activities of daily living after surgery.
- Conditions
- Shoulder Arthroscopy, Knee Arthroscopy
- Being tested
- Sugar pill, Gabapentin, Clonidine
- Keywords
- Shoulder arthroscopy, Knee arthroscopy, Clonidine, Gabapentin, Pain management, Ambulatory surgery, Perioperative outcome, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar pillDrug
Also called placebo
Dosage form: capsule, by mouth
Dosage: not applicable
Frequency and Dosage:
- once in the preoperative holding area and once before discharge from PACU
- continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
GabapentinDrug
Also called Neurontin
Dosage form: capsule, by mouth
Dosage: 600 mg
Frequency and duration:
- once in the preoperative holding area and once before discharge from PACU
- continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
ClonidineDrug
Also called Catapres
Dosage form: capsule, by mouth
Dosage: 0.2 mg
Frequency and duration:
- once in the preoperative holding area and once before discharge from PACU
- continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Frequency and Dosage:
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. Receives: Drug: Gabapentin; Drug: Clonidine |
| Clonidine | Active comparator | Dosage: 0.2 mg
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. Receives: Drug: Sugar pill; Drug: Gabapentin |
| Gabapentin | Active comparator | Dosage: 600 mg
* once in the preoperative holding area and once before discharge from PACU
* continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. Receives: Drug: Sugar pill; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain using a Verbal Rating Scale (VRS)
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
Measured: 1 month
Secondary outcomes (4)
Opioid consumption obtained from the recorded data
Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery)
Measured: 1 month
postoperative nausea and vomiting using a Verbal Rating Scale
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
Measured: 1 month
return to normal activities of daily living using follow up questionnaires
return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)
Measured: 1 month
Patient satisfaction using a verbal rating scale from 0 to 100
0= Not satisfied 100= Excellent
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJun 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Several studies going on at the same time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Wender, Cedars-Sinai Medical Center
- Investigators
- Ronald H Wender, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112878
- Sponsor's protocol ID
- Pro00019373
- Status last verified
- Sep 2015
- First submitted
- 23 Apr 2010
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-controlled Study to Evaluate the Analgesic Efficacy of Oral Clonidine and Gabapentin as Part of a Multi-modal Analgesic Regimen for Preventing Pain After Arthroscopic Shoulder or Knee Surgery
- ClinicalTrials.gov ID
- NCT01112878
- Acronym / sponsor ID
- Pro00019373
- Conditions
- Shoulder Arthroscopy, Knee Arthroscopy
- Keywords
- Shoulder arthroscopy, Knee arthroscopy, Clonidine, Gabapentin, Pain management, Ambulatory surgery, Perioperative outcome, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Several studies going on at the same time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 29 Apr 2010 (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 purpose of this research is to investigate the non-opioid (non-narcotic) pain-relieving medications clonidine and gabapentin to see if they decrease the amount of opioid pain medications needed after surgery, thereby reducing opioid-related side effects, and time required to return to normal activities of daily living after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: Gabapentin, Drug: ClonidineFrequency and Dosage: * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. |
| Clonidine | Active comparator | Drug: Sugar pill, Drug: GabapentinDosage: 0.2 mg * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. |
| Gabapentin | Active comparator | Drug: Sugar pill, Drug: ClonidineDosage: 600 mg * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled to undergo arthroscopic joint surgery
- Willingness and ability to sign an informed consent document
- No allergies to clonidine, gabapentin, anesthetic or analgesic medications
- 18 - 80 years of age
- American Society of Anesthesiologists (ASA) Class I - III adults of either sex
Key exclusion criteria (9 listed)
- Patients with known allergy, hypersensitivity or contraindications to clonidine, gabapentin, anesthetic or analgesic medications
- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
- Patients with chronic hypertension or pain syndromes receiving clonidine or gabapentin, respectively.
- Pregnant or lactating women
- Subjects with a history of alcohol or drug abuse within the past 3 months
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 |
|---|---|---|
| Sugar pillAlso: placeboDosage form: capsule, by mouth Dosage: not applicable Frequency and Dosage: * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. | Drug | Clonidine, Gabapentin |
| GabapentinAlso: NeurontinDosage form: capsule, by mouth Dosage: 600 mg Frequency and duration: * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. | Drug | Clonidine, Sugar Pill |
| ClonidineAlso: CatapresDosage form: capsule, by mouth Dosage: 0.2 mg Frequency and duration: * once in the preoperative holding area and once before discharge from PACU * continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery. | Drug | Gabapentin, Sugar Pill |
Primary outcome
Postoperative Pain using a Verbal Rating Scale (VRS)
Time frame: 1 month
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery
4 secondary outcomes
Opioid consumption obtained from the recorded data
Time frame: 1 month
postoperative nausea and vomiting using a Verbal Rating Scale
Time frame: 1 month
return to normal activities of daily living using follow up questionnaires
Time frame: 1 month
Patient satisfaction using a verbal rating scale from 0 to 100
Time frame: 1 month
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 14 Sep 2015.
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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.
Ronald H Wender, MD principal investigator
Cedars-Sinai 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 Sugar pill, Gabapentin and Clonidine in people with Shoulder Arthroscopy and Knee Arthroscopy, run by Cedars-Sinai Medical Center 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 6 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: withdrawn, as of the sponsor's last update on 14 Sep 2015. 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?
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?
Postoperative Pain using a Verbal Rating Scale (VRS) (time frame: 1 month). 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 14 Sep 2015.