Breast CancerNCT02659501
Liposomal Bupivacaine in Implant Based Breast Reconstruction
A study testing Liposomal bupivacaine, Bupivacaine with epinephrine and Morphine sulfate in people with Breast Cancer and Postoperative Pain, run by Loma Linda University at 1 site in United States.
Trial summary
Objectives: 1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels. 2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events. 3. To evaluate the effect of liposomal bupivacaine on length of hospital stay. 4. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Pain
- What is being tested?
- Liposomal bupivacaine, Bupivacaine with epinephrine and Morphine sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2017
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy
Who cannot join
- Women who are unable to give informed consent to participate in this study
- Women with a documented history of hypersensitivity reactions to local-anesthetic agents
- Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
- Women who are currently pregnant
- Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
- Women with impaired hepatic function
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health System
Loma Linda, California, 92354
About this study
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
Read the detailed description
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.
Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.
The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.
- Conditions
- Breast Cancer, Postoperative Pain
- Being tested
- Liposomal bupivacaine, Bupivacaine with epinephrine, Morphine sulfate, Hydrocodone/acetaminophen, Diazepam
- Keywords
- Breast reconstruction, Bupivacaine, Liposomal bupivacaine, Postoperative analgesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
Bupivacaine with epinephrineDrug
Also called Marcaine, Sensorcaine
Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
Morphine sulfateDrug
Also called Roxanol
Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
Hydrocodone/acetaminophenDrug
Also called Norco
Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
DiazepamDrug
Also called Valium
Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with epinephrine injections | Active comparator | Patients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam. Receives: Drug: Bupivacaine with epinephrine; Drug: Morphine sulfate; Drug: Hydrocodone/acetaminophen; Drug: Diazepam |
| Liposomal bupivacaine | Experimental | Patients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam. Receives: Drug: Liposomal bupivacaine; Drug: Morphine sulfate; Drug: Hydrocodone/acetaminophen; Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
Measured: Average Pain Scores 24 hours Post-Operatively
The Effect of Liposomal Bupivacaine on Antiemetic Consumption
The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.
Measured: 24 hours
The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.
Measured: 24 hours
The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.
Measured: 24 hours
The Effect of Liposomal Bupivacaine on Length of Hospital Stay
Length of hospital stay will be determined for patients in each group, in total hours.
Measured: 24-60 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionJul 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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhas Gupta, MD, PhD, Loma Linda University
- Investigators
- Subhas C. Gupta, MD, PhD, Principal investigator, Loma Linda UniversityWendy W. Wong, MD, Study director, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659501
- Sponsor's protocol ID
- 5150012
- Status last verified
- Dec 2020
- First submitted
- 29 Jun 2015
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
PubMed 18827631Wheble GA, Tan EK, Turner M, Durrant CA, Heppell S. Surgeon-administered, intra-operative transversus abdominis plane block in autologous breast reconstruction: a UK hospital experience. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1665-70. doi: 10.1016/j.bjps.2013.07.017. Epub 2013 Jul 31.
PubMed 23910912Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
PubMed 22900785Richard BM, Ott LR, Haan D, Brubaker AN, Cole PI, Nelson KG, Ross PE, Rebelatto MC, Newton PE. The safety and tolerability evaluation of DepoFoam bupivacaine (bupivacaine extended-release liposome injection) administered by incision wound infiltration in rabbits and dogs. Expert Opin Investig Drugs. 2011 Oct;20(10):1327-41. doi: 10.1517/13543784.2011.611499. Epub 2011 Aug 26.
PubMed 21867476Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.
PubMed 20357145
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine in Implant Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02659501
- Acronym / sponsor ID
- 5150012
- Conditions
- Breast Cancer, Postoperative Pain
- Keywords
- Breast reconstruction, Bupivacaine, Liposomal bupivacaine, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
Detailed description
Objectives:
- To evaluate the effect of liposomal bupivacaine on postoperative pain levels.
- To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.
- To evaluate the effect of liposomal bupivacaine on length of hospital stay.
- To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.
- To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.
The objective of this project is to evaluate the role of liposomal bupivacaine in postoperative pain control following tissue expander and implant based breast reconstruction. This unique formulation of bupivacaine lends this drug a longer duration of action and reduced plasma bupivacaine concentrations compared to plain bupivacaine. This agent has been demonstrated to be safe, well tolerated, and effective in a number of different clinical applications. However, its role has yet to be evaluated in the context of breast reconstruction.
Thus, the authors propose the first, randomized, controlled clinical trial of liposomal bupivacaine for postoperative pain management following tissue expander and implant based breast reconstruction. Patients will be stratified into two study groups. Patients in the Group 1 (Bupivacaine) will be treated intraoperatively with injections of 0.5% bupivacaine and epinephrine 1:200,000, with 50 mg delivered to perform a field block of each pocket. This is the current standard of care. Patients in the Group 2 (Liposomal Bupivacaine) will be treated intraoperatively with injections of 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. This is the experimental intervention. Postoperatively, the investigators will assess pain levels, opioid consumption, opioid related adverse events, length of stay, and satisfaction.
The findings from this study will allow the authors to better elucidate the role of liposomal bupivacaine in expander/implant based breast reconstruction. In doing so, they may allow the authors to identify the ideal pain regimen for these patients. This holds important implications, with the potential to reduce postoperative pain, opioid consumption, opioid related adverse events, length of stay, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with epinephrine injections | Active comparator | Drug: Bupivacaine with epinephrine, Drug: Morphine sulfate, Drug: Hydrocodone/acetaminophen, Drug: DiazepamPatients in the control arm of the study will be treated intra-operatively with standard of care, 0.5% bupivacaine and epinephrine injection (1:200,000), with 50 mg delivered into each breast pocket to perform a field block of the breast pocket (see below). Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam. |
| Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine, Drug: Morphine sulfate, Drug: Hydrocodone/acetaminophen, Drug: DiazepamPatients in the experimental arm of the study will be treated intra-operatively with 1.33% liposomal bupivacaine, with 133 mg delivered to perform a field block of each breast pocket. Postoperatively, these patients will be treated with standard postoperative pain control, including narcotics as needed, such as morphine sulfate and hydrocodone/acetaminophen, and muscle relaxants, such as diazepam. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy
Key exclusion criteria (6 listed)
- Women who are unable to give informed consent to participate in this study
- Women with a documented history of hypersensitivity reactions to local-anesthetic agents
- Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
- Women who are currently pregnant
- Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander
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 |
|---|---|---|
| Liposomal bupivacaineAlso: ExparelLiposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action. | Drug | Liposomal bupivacaine |
| Bupivacaine with epinephrineAlso: Marcaine, SensorcaineBupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia. | Drug | Bupivacaine with epinephrine injections |
| Morphine sulfateAlso: RoxanolMorphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain. | Drug | Bupivacaine with epinephrine injections, Liposomal bupivacaine |
| Hydrocodone/acetaminophenAlso: NorcoHydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain. | Drug | Bupivacaine with epinephrine injections, Liposomal bupivacaine |
| DiazepamAlso: ValiumDiazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction. | Drug | Bupivacaine with epinephrine injections, Liposomal bupivacaine |
Primary outcome
The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
Time frame: Average Pain Scores 24 hours Post-Operatively
Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.
The Effect of Liposomal Bupivacaine on Antiemetic Consumption
Time frame: 24 hours
The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.
The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
Time frame: 24 hours
Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.
The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
Time frame: 24 hours
Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.
The Effect of Liposomal Bupivacaine on Length of Hospital Stay
Time frame: 24-60 hours
Length of hospital stay will be determined for patients in each group, in total hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18827631Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
- Background: PubMed 23910912Wheble GA, Tan EK, Turner M, Durrant CA, Heppell S. Surgeon-administered, intra-operative transversus abdominis plane block in autologous breast reconstruction: a UK hospital experience. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1665-70. doi: 10.1016/j.bjps.2013.07.017. Epub 2013 Jul 31.
- Background: PubMed 22900785Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
- Background: PubMed 21867476Richard BM, Ott LR, Haan D, Brubaker AN, Cole PI, Nelson KG, Ross PE, Rebelatto MC, Newton PE. The safety and tolerability evaluation of DepoFoam bupivacaine (bupivacaine extended-release liposome injection) administered by incision wound infiltration in rabbits and dogs. Expert Opin Investig Drugs. 2011 Oct;20(10):1327-41. doi: 10.1517/13543784.2011.611499. Epub 2011 Aug 26.
- Background: PubMed 20357145Davidson EM, Barenholz Y, Cohen R, Haroutiunian S, Kagan L, Ginosar Y. High-dose bupivacaine remotely loaded into multivesicular liposomes demonstrates slow drug release without systemic toxic plasma concentrations after subcutaneous administration in humans. Anesth Analg. 2010 Apr 1;110(4):1018-23. doi: 10.1213/ANE.0b013e3181d26d2a.
- 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.
Subhas C. Gupta, MD, PhD principal investigator
Loma Linda University
Wendy W. Wong, MD study director
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal bupivacaine, Bupivacaine with epinephrine and Morphine sulfate in people with Breast Cancer and Postoperative Pain, run by Loma Linda University 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Jan 2021. 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 21 Aug 2019). 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?
The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1. (time frame: Average Pain Scores 24 hours Post-Operatively). The study lists 5 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 NCT02659501, which also lists 5 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 12 Jan 2021.