Postoperative PainNCT01566838
Continuous Subpleural Infusion of Bupivacaine
A study testing Subpleural pain catheter with infusion of 0.125% bupivacaine and Standard acute pain management in people with Postoperative Pain, run by Inova Health Care Services at 1 site in United States.
Trial summary
Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Subpleural pain catheter with infusion of 0.125% bupivacaine and Standard acute pain management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years of age
- Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Who cannot join
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic use of pain medication (narcotics or NSAIDS), sedatives or hypnotics
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
- Renal dysfunction (eGFR < 60ml/min/1.73m2)
Show all 11Show fewer
- History of peptic ulcerative disease
- Sleep apnea in need of Bipap
- Severe COPD requiring continuous oxygen supplementation
- Inability to consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy
Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del
Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval.
Read more
Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay.
The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications.
Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay.
Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology: Total amount of narcotic pain medication administered through postoperative day 7, will be compared between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.
Read the detailed description
Video-Assisted Thoracic Surgery (VATS) has been shown to hasten patient recovery by attenuating the physiologic stress of surgery and decreasing post-operative pain. Despite this approach, incisions in the chest are proportionally more painful than in other parts of the body, and most patients require some form of narcotic pain medication.
Multiple strategies for post-operative pain control have been attempted in thoracic surgery with no obvious superiority of one versus another. Pain catheters have been increasingly used over the past decade in different surgical procedures in order to minimize incisional pain for the first 3 to 7 days after an operation. The published literature is equivocal as to the efficacy of such approach following thoracic surgery with most recent series reporting no benefit in the use of these catheters. Of utmost importance is the placement techniques described thus far, which in our opinion, have been suboptimal.
In order for a pain catheter to work, the infused local anesthetic has to constantly bathe the nerve in question thus preventing painful stimuli from being transmitted. It is hard to dispute the ability of local anesthetic to block pain conduction. Consequently, the success of the intervention is directly dependent on the placement technique to achieve such goal, hence the rationale for our study.
- Conditions
- Postoperative Pain
- Being tested
- Subpleural pain catheter with infusion of 0.125% bupivacaine, Standard acute pain management
- Keywords
- Visual analog pain score, Length of stay, Hospital Cost, Subpleural pain catheter, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subpleural pain catheter with infusion of 0.125% bupivacaineDrug
Also called On-q pump
Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
Standard acute pain managementDrug
A standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures.
Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV, neuromuscular reversal agents, and ondansetron 4mg. Fentanyl will be given, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will be followed. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.
| Study group | Role | What they receive |
|---|---|---|
| On-q pump | Active comparator | Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days. Receives: Drug: Subpleural pain catheter with infusion of 0.125% bupivacaine |
| Standard of care | Active comparator | Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will also be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.
The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3. Receives: Drug: Standard acute pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With and Without 30-Day Pain Medication Usage
The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.
Measured: Postoperative day 1 through postoperative day 30
Secondary outcomes (5)
7-day Paresthesia
Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7
Measured: Postoperative day 1 through day 7
Length of Stay
Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
30-day Incidence of Parasthesia
30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)
Measured: 30 days
Return to Work
Returned to work in 30 days?
Measured: 30 days
Resumed Physical Activity
Did the patient resume physical activity.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
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 (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel L Fortes, MD, Principal investigator, Cardiac, Vascular, & Thoracic Surgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566838
- Sponsor's protocol ID
- 120104onq
- Status last verified
- Dec 2017
- First submitted
- 21 Feb 2012
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
PubMed 19022040Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
PubMed 19699918Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
PubMed 1914056Gurvich EB, Gladkova EV. [The results and outlook of a clinico-epidemiological study of the problem of the carcinogenic hazard in industry]. Gig Tr Prof Zabol. 1992;(7):17-20. Russian.
PubMed 1296910Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
PubMed 9725371American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
PubMed 15166580
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Continuous Subpleural Infusion of Bupivacaine After Thoracoscopy
- ClinicalTrials.gov ID
- NCT01566838
- Acronym / sponsor ID
- 120104onq
- Conditions
- Postoperative Pain
- Keywords
- Visual analog pain score, Length of stay, Hospital Cost, Subpleural pain catheter, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 4 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del
Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval.
Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay.
The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications.
Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay.
Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology: Total amount of narcotic pain medication administered through postoperative day 7, will be compared between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.
Detailed description
Video-Assisted Thoracic Surgery (VATS) has been shown to hasten patient recovery by attenuating the physiologic stress of surgery and decreasing post-operative pain. Despite this approach, incisions in the chest are proportionally more painful than in other parts of the body, and most patients require some form of narcotic pain medication.
Multiple strategies for post-operative pain control have been attempted in thoracic surgery with no obvious superiority of one versus another. Pain catheters have been increasingly used over the past decade in different surgical procedures in order to minimize incisional pain for the first 3 to 7 days after an operation. The published literature is equivocal as to the efficacy of such approach following thoracic surgery with most recent series reporting no benefit in the use of these catheters. Of utmost importance is the placement techniques described thus far, which in our opinion, have been suboptimal.
In order for a pain catheter to work, the infused local anesthetic has to constantly bathe the nerve in question thus preventing painful stimuli from being transmitted. It is hard to dispute the ability of local anesthetic to block pain conduction. Consequently, the success of the intervention is directly dependent on the placement technique to achieve such goal, hence the rationale for our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-q pump | Active comparator | Drug: Subpleural pain catheter with infusion of 0.125% bupivacainePatients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days. |
| Standard of care | Active comparator | Drug: Standard acute pain managementPatients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will also be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation. The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients over 18 years of age
- Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Key exclusion criteria (11 listed)
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic use of pain medication (narcotics or NSAIDS), sedatives or hypnotics
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
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 |
|---|---|---|
| Subpleural pain catheter with infusion of 0.125% bupivacaineAlso: On-q pumpPatients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days. | Drug | On-q pump |
| Standard acute pain managementA standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV, neuromuscular reversal agents, and ondansetron 4mg. Fentanyl will be given, as needed, to facilitate patient comfort and extubation. The ASA guidelines for acute pain management in the perioperative period will be followed. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3. | Drug | Standard of care |
Primary outcome
Number of Participants With and Without 30-Day Pain Medication Usage
Time frame: Postoperative day 1 through postoperative day 30
The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.
5 secondary outcomes
7-day Paresthesia
Time frame: Postoperative day 1 through day 7
Length of Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
30-day Incidence of Parasthesia
Time frame: 30 days
Return to Work
Time frame: 30 days
Resumed Physical Activity
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19022040Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.
- Background: PubMed 19699918Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139.
- Background: PubMed 1914056Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451.
- Background: PubMed 1296910Gurvich EB, Gladkova EV. [The results and outlook of a clinico-epidemiological study of the problem of the carcinogenic hazard in industry]. Gig Tr Prof Zabol. 1992;(7):17-20. Russian.
- Background: PubMed 9725371Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2.
- Background: PubMed 15166580American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available.
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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.
Daniel L Fortes, MD principal investigator
Cardiac, Vascular, & Thoracic Surgery Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subpleural pain catheter with infusion of 0.125% bupivacaine and Standard acute pain management in people with Postoperative Pain, run by Inova Health Care Services 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 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 20 Dec 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2016). 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?
Number of Participants With and Without 30-Day Pain Medication Usage (time frame: Postoperative day 1 through postoperative day 30). 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 NCT01566838, which also lists 6 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 20 Dec 2017.