Acute PainPhase 4NCT02519023
TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
A Phase 4 study testing Liposomal Bupivacaine, Bupivacaine and Ultrasound in people with Acute Pain, run by University of Minnesota at 1 site in United States.
Trial summary
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Pain
- What is being tested?
- Liposomal Bupivacaine, Bupivacaine and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- Females >/=18-years of age
- Scheduled for laparoscopic/robot-assisted hysterectomy.
Who cannot join
- Contraindication to surgical infiltration or regional blockade
- History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder
- Inability to understand the informed consent and demands of the study
- Surgery scheduled to start after 1700
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.
Read the detailed description
This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.
In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.
A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 This layer is found using an ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side.
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures.
Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
- Conditions
- Acute Pain
- Being tested
- Liposomal Bupivacaine, Bupivacaine, Ultrasound, Epinephrine, acetaminophen
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.
BupivacaineDrug
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
UltrasoundDevice
An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
EpinephrineDrug
TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.
acetaminophenDrug
all individuals will receive scheduled acetaminophen (1 gram every 6 hours),
ibuprofenDrug
all individuals will receive scheduled ibuprofen (800 mg every 8 hours)
OxycodoneDrug
all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
| Study group | Role | What they receive |
|---|---|---|
| TAP-Block with liposomal bupivacaine | Experimental | TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site. Receives: Drug: Liposomal Bupivacaine; Device: Ultrasound; Drug: Epinephrine; Drug: acetaminophen; Drug: ibuprofen; Drug: Oxycodone |
| Surgical infiltration with bupivacaine | Active comparator | Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. Receives: Drug: Bupivacaine; Device: Ultrasound; Drug: acetaminophen; Drug: ibuprofen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Use for Pain Control
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
Measured: 72 hours
Secondary outcomes (13)
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.
Measured: 0-72 hours post-procedure
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Measured: 0-24 post-procedure
Quality of Recovery 15 (QoR15) Score
The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.
Measured: 72 hours post-procedure
Overall Benefit of Analgesia Score (OBAS)
The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.
Measured: 72 hours post-procedure
Number of Participants With Nausea and Vomiting
Measured: 72 hours post-procedure
Length of Time in Phase 1 and Phase 2 of Recovery
time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.
Measured: an expected average of 120 mins
Number of Patients Admitted Post Operatively
Measured: 72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery
opioids in mg of morphine equivalents used from 24-48 hours after surgery
Measured: 24-48 hours after the end of surgery
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
opioid use from time 48-72 hours in mg morphine equivalents
Measured: 48-72 hours after end of surgery
Patient Satisfaction With Pain Management
number of patients who answered yes to if they were satisfied with their pain management
Measured: at 72 hours after surgery
Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Measured: 0-24 hours after surgery
Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Measured: 24-48 hours after surgery
Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.
Measured: 48-72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionJun 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 Acute PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Geller, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519023
- Sponsor's protocol ID
- 7152222222
- Status last verified
- Jan 2019
- First submitted
- 28 Jul 2015
- Last updated
- 8 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
PubMed 25170277Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
PubMed 22381092Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
PubMed 19561014Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
PubMed 20175754Singh M, Chin KJ, Chan V. Ultrasound-guided transversus abdominis plane (TAP) block: a useful adjunct in the management of postoperative respiratory failure. J Clin Anesth. 2011 Jun;23(4):303-6. doi: 10.1016/j.jclinane.2010.05.012.
PubMed 21663815
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy
- ClinicalTrials.gov ID
- NCT02519023
- Acronym / sponsor ID
- 7152222222
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.
Detailed description
This is a double blinded randomized study. All patients will receive one form of local anesthetic pain relief either from TAP or infiltration. Patients will be randomized to one of two study arms in a double-blinded, placebo controlled study. All patients will receive a TAP infiltration and all patients will receive infiltration into the incision.
In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site.
In the second arm the bilateral TAP infiltration will consist of 30 mL of normal saline per side. In the same arm the surgeon infiltration will consist of 10 mL of 0.25% bupivacaine per port site. The surgeon infiltration will consist of 5 ml of 0.25% bupivacaine prior to incision and 5 ml of 0.25% bupivacaine prior to closure at each port site.
A TAP infiltration is an injection of local anesthetic under the covering of the transversus abdominis muscle layer which provides effective post operative analgesia.2-5 This layer is found using an ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound the investigators can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is infiltrated into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and facial layers of the abdomen. This is currently standard of care at our institution and will be performed within one hour of surgical incision. The injection will consist of 10 mL of 0.25% bupivacaine with epinephrine followed by 20 mL of liposomal bupivacaine saline mixture or 10 ml of saline followed by 20 ml of saline and then repeated on the contralateral side.
Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
Investigational Drug Service (IDS) pharmacy will be charged with the blinding of medications vs. saline for these procedures.
Following the procedure, all individuals will receive scheduled acetaminophen (1 gram every 6 hours), scheduled ibuprofen (800 mg every 8 hours), and PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP-Block with liposomal bupivacaine | Experimental | Drug: Liposomal Bupivacaine, Device: Ultrasound, Drug: Epinephrine, Drug: acetaminophen, Drug: ibuprofen, Drug: OxycodoneTAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. In the same arm the surgeon infiltration into the incision will consist of 10 ml of normal saline per port site, 5 ml prior to incision and 5 ml prior to closure at each port site. |
| Surgical infiltration with bupivacaine | Active comparator | Drug: Bupivacaine, Device: Ultrasound, Drug: acetaminophen, Drug: ibuprofen, Drug: OxycodoneSurgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-III
- Females >/=18-years of age
- Scheduled for laparoscopic/robot-assisted hysterectomy.
Key exclusion criteria (4 listed)
- Contraindication to surgical infiltration or regional blockade
- History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder
- Inability to understand the informed consent and demands of the study
- Surgery scheduled to start after 1700
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: ExparelIn one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side. | Drug | TAP-Block with liposomal bupivacaine |
| BupivacaineSurgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions. | Drug | Surgical infiltration with bupivacaine |
| UltrasoundAn ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane | Device | Surgical infiltration with bupivacaine, TAP-Block with liposomal bupivacaine |
| EpinephrineTAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine. | Drug | TAP-Block with liposomal bupivacaine |
| acetaminophenall individuals will receive scheduled acetaminophen (1 gram every 6 hours), | Drug | Surgical infiltration with bupivacaine, TAP-Block with liposomal bupivacaine |
| ibuprofenall individuals will receive scheduled ibuprofen (800 mg every 8 hours) | Drug | Surgical infiltration with bupivacaine, TAP-Block with liposomal bupivacaine |
| Oxycodoneall individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale. | Drug | Surgical infiltration with bupivacaine, TAP-Block with liposomal bupivacaine |
Primary outcome
Total Opioid Use for Pain Control
Time frame: 72 hours
total opioid used from time 0 after surgery through 72 hours after surgery was complete.
13 secondary outcomes
Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
Time frame: 0-72 hours post-procedure
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Time frame: 0-24 post-procedure
Quality of Recovery 15 (QoR15) Score
Time frame: 72 hours post-procedure
Overall Benefit of Analgesia Score (OBAS)
Time frame: 72 hours post-procedure
Number of Participants With Nausea and Vomiting
Time frame: 72 hours post-procedure
Length of Time in Phase 1 and Phase 2 of Recovery
Time frame: an expected average of 120 mins
Number of Patients Admitted Post Operatively
Time frame: 72 hours post-procedure
Opioid Used From 24-48 Hours Post Surgery
Time frame: 24-48 hours after the end of surgery
Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
Time frame: 48-72 hours after end of surgery
Patient Satisfaction With Pain Management
Time frame: at 72 hours after surgery
Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
Time frame: 0-24 hours after surgery
Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
Time frame: 24-48 hours after surgery
Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
Time frame: 48-72 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25170277Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.
- Background: PubMed 22381092Mitchell AU, Torup H, Hansen EG, Petersen PL, Mathiesen O, Dahl JB, Rosenberg J, Moller AM. Effective dermatomal blockade after subcostal transversus abdominis plane block. Dan Med J. 2012 Mar;59(3):A4404.
- Background: PubMed 19561014Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.
- Background: PubMed 20175754Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
- Background: PubMed 21663815Singh M, Chin KJ, Chan V. Ultrasound-guided transversus abdominis plane (TAP) block: a useful adjunct in the management of postoperative respiratory failure. J Clin Anesth. 2011 Jun;23(4):303-6. doi: 10.1016/j.jclinane.2010.05.012.
- 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.
Melissa Geller, MD principal investigator
University of Minnesota
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 Liposomal Bupivacaine, Bupivacaine and Ultrasound in people with Acute Pain, run by University of Minnesota 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 4 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 8 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2018). 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?
Total Opioid Use for Pain Control (time frame: 72 hours). 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 NCT02519023, 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 8 Feb 2019.