Phantom LimbNCT03592901
Phantom Limb Experience After Brachial Plexus Anesthesia
An observational study of Phantom Limb and Brachial Plexus Block, run by University of Tennessee at 1 site in United States.
Trial summary
This study examines the sensations felt by patients receiving brachial plexus anesthesia for shoulder surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb, Brachial Plexus Block
- What is being tested?
- brachial plexus anesthesia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2016to 31 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient already receiving BPA as a part of a previously planned shoulder surgery
Who may be able to join
- Male or female subjects receiving brachial plexus anesthesia prior to upper extremity surgery
- Age 18 years or greater
- Ability to undergo 5-10 minutes of testing for multiple sessions: before anesthesia, following anesthesia but before surgery, following surgery while anesthesia remains effective, and throughout return of normal sensation
- Likely to complete all required sessions
Who cannot join
- Age less than 18 years old
- Physical or mental health condition which may interfere with being able to complete all required sessions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UTHSC
Memphis, Tennessee, 38103
Jack W Tsao, MD, DPhil, 901-287-6326, jtsao@uthsc.edu
Jen Pryweller, PhD, 901-287-6326, jprywel@uthsc.edu
About this study
This study examines the sensations felt by patients receiving brachial plexus anesthesia for shoulder surgeries.
Read the detailed description
- Purpose: The purpose of this study is to investigate whether phantom limb pain and/or sensations can arise after induction of BPA prior to upper extremity surgery. In addition, this study aims to investigate if there is cortical remapping of the hand sensation onto the face before and after surgery. The outcome of this research will provide insight into the characteristics of cortical reorganization and how this correlates to phantom limbs, phantom pain, and hand-to-face remapping.
- Rationale, Research has yet to elucidate the etiology of phantom limb experiences, and the debate over peripheral or central nervous system mechanisms remains contentious. Many recent studies on PLP have investigated the relationship between cortical reorganization and PLP with the objective of discerning new ways to minimize pain in the residual limb in amputees. However, this approach has not been successful in describing the changes that occur in the peripheral or the central nervous systems and have not been able to concretely link any changes to PLP. Studying patients undergoing brachial plexus anesthesia (BPA) prior to upper extremity surgery has the potential to aid in the understanding of cortical remapping and the roles of the peripheral and central nervous systems in not only PLP but PLS as well. During upper extremity surgery, there have been reports that patients do not sense repositioning of the upper limb by the surgeon after BPA takes effect. This is similar to the phenomenon of the immobile, "frozen" limb occasionally experienced by major limb amputees. The purpose of this study is to investigate whether phantom limb pain and/or sensations can arise after induction of BPA prior to upper extremity surgery. In addition, this study aims to investigate if there is cortical remapping of the hand sensation onto the face before and after surgery. The outcome of this research will provide insight into the characteristics of cortical reorganization and how this correlates to phantom limbs, phantom pain, and hand-to-face remapping.
- Study/Project Population, The general subject population includes male and female subjects greater than 18 years of age who are receiving BPA for the purposes of upper extremity surgery. Since this is a pilot study, we seek to recruit thirty (30) patients.
- Research Design, To complete this study, a sensory map of participants' facial responses to the brushing of a Q-tip will be collected by a researcher before, and again after, BPA has been induced. In addition, follow-up phone sessions will be conducted on the day after surgery while BPA is still in effect, and daily, up to seven days, to identify whether participants are experiencing any changes in hand-to-face remapping should it be detected. This will be used to determine if cortical remapping has occurred as well as the time course of onset and reversal.
- Study/Project Procedures, During the consent process all sections of the study will be described in detail. Participants will be able to determine if they can and would like to be enrolled in the study, Phantom Limb Experience After Brachial Plexus Anesthesia. 30 patients undergoing BPA in preparation for upper extremity surgery will be recruited for up to 10 data collection sessions. The first session will take place before the administration of BPA. The next sessions will occur after the administration of BPA and prior to surgery. A third session will occur after surgery is completed and prior to discharge home. Once the patient is discharged, follow-up phone sessions will be conducted in order to determine if hand-to-face remapping has occurred overnight and what the time course of onset and reversal of remapping and reorganization is. After obtaining informed consent, facial mapping of the patient's responses to light touch will be collected. To do this, a researcher will brush a Q-tip over all areas of the face, beginning at the forehead and working down towards the chin, while the participant's eyes are closed. During this process, the participant will be required to inform the researcher where the perception of brushing is being felt. During the follow-up phone sessions, the patient will answer questions about phantom limb sensations and pain, and will also be asked to touch different areas of his/her own face and report where the sensations are being perceived.
- Outcome Measures. Data will be collected in the form of a verbal report. Participants will be instructed to inform researchers about the location that the brushing sensation is portrayed. In addition any feeling of phantom sensations or pain will also be recorded. Verbal reports will be collected at all in person sessions as well as phone follow us sessions. Analysis of these reports will include: the determination of the presence or absence of hand to face remapping, a detailed time course of onset and reversal if it occurs, specific locations of the hand-to-face remapping, changes in location of sensation reports prior to and following BPA, presence or absence of phantom limb sensations, such as the inability to feel limb repositioning, as well as the presence or absence of PLP. If PLP is experienced, scores of overall pain ratings will be conducted using a 10-cm visual analogue scale composed of a linear line where one end is labeled "no pain" and the other end is labeled "worst pain possible."
- Conditions
- Phantom Limb, Brachial Plexus Block
- Being tested
- brachial plexus anesthesia
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachial plexus anesthesiaDrug
Anesthesia to some part of the brachial plexus prior to surgery. Patients are already receiving this regardless of participation in study.
| Study group | Role | What they receive |
|---|---|---|
| BPA Patients | Participants that are receiving brachial plexus anesthesia for a previously planned shoulder surgery. Receives: Drug: brachial plexus anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Report
descriptions of sensations
Measured: 3 days
Secondary outcomes (1)
Visual analog scale
100mm line, no pain on one end, worst pain of life of another end. Participants mark spot on line. Answers are reported as a measure from the no pain end of the line.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start8 Aug 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom LimbStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jack Tsao, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592901
- Sponsor's protocol ID
- 16-04696-XP
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phantom Limb Experience After Brachial Plexus Anesthesia
- ClinicalTrials.gov ID
- NCT03592901
- Acronym / sponsor ID
- 16-04696-XP
- Conditions
- Phantom Limb, Brachial Plexus Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Jul 2018 (actual)
- 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.
This study examines the sensations felt by patients receiving brachial plexus anesthesia for shoulder surgeries.
Detailed description
- Purpose: The purpose of this study is to investigate whether phantom limb pain and/or sensations can arise after induction of BPA prior to upper extremity surgery. In addition, this study aims to investigate if there is cortical remapping of the hand sensation onto the face before and after surgery. The outcome of this research will provide insight into the characteristics of cortical reorganization and how this correlates to phantom limbs, phantom pain, and hand-to-face remapping.
- Rationale, Research has yet to elucidate the etiology of phantom limb experiences, and the debate over peripheral or central nervous system mechanisms remains contentious. Many recent studies on PLP have investigated the relationship between cortical reorganization and PLP with the objective of discerning new ways to minimize pain in the residual limb in amputees. However, this approach has not been successful in describing the changes that occur in the peripheral or the central nervous systems and have not been able to concretely link any changes to PLP. Studying patients undergoing brachial plexus anesthesia (BPA) prior to upper extremity surgery has the potential to aid in the understanding of cortical remapping and the roles of the peripheral and central nervous systems in not only PLP but PLS as well. During upper extremity surgery, there have been reports that patients do not sense repositioning of the upper limb by the surgeon after BPA takes effect. This is similar to the phenomenon of the immobile, "frozen" limb occasionally experienced by major limb amputees. The purpose of this study is to investigate whether phantom limb pain and/or sensations can arise after induction of BPA prior to upper extremity surgery. In addition, this study aims to investigate if there is cortical remapping of the hand sensation onto the face before and after surgery. The outcome of this research will provide insight into the characteristics of cortical reorganization and how this correlates to phantom limbs, phantom pain, and hand-to-face remapping.
- Study/Project Population, The general subject population includes male and female subjects greater than 18 years of age who are receiving BPA for the purposes of upper extremity surgery. Since this is a pilot study, we seek to recruit thirty (30) patients.
- Research Design, To complete this study, a sensory map of participants' facial responses to the brushing of a Q-tip will be collected by a researcher before, and again after, BPA has been induced. In addition, follow-up phone sessions will be conducted on the day after surgery while BPA is still in effect, and daily, up to seven days, to identify whether participants are experiencing any changes in hand-to-face remapping should it be detected. This will be used to determine if cortical remapping has occurred as well as the time course of onset and reversal.
- Study/Project Procedures, During the consent process all sections of the study will be described in detail. Participants will be able to determine if they can and would like to be enrolled in the study, Phantom Limb Experience After Brachial Plexus Anesthesia. 30 patients undergoing BPA in preparation for upper extremity surgery will be recruited for up to 10 data collection sessions. The first session will take place before the administration of BPA. The next sessions will occur after the administration of BPA and prior to surgery. A third session will occur after surgery is completed and prior to discharge home. Once the patient is discharged, follow-up phone sessions will be conducted in order to determine if hand-to-face remapping has occurred overnight and what the time course of onset and reversal of remapping and reorganization is. After obtaining informed consent, facial mapping of the patient's responses to light touch will be collected. To do this, a researcher will brush a Q-tip over all areas of the face, beginning at the forehead and working down towards the chin, while the participant's eyes are closed. During this process, the participant will be required to inform the researcher where the perception of brushing is being felt. During the follow-up phone sessions, the patient will answer questions about phantom limb sensations and pain, and will also be asked to touch different areas of his/her own face and report where the sensations are being perceived.
- Outcome Measures. Data will be collected in the form of a verbal report. Participants will be instructed to inform researchers about the location that the brushing sensation is portrayed. In addition any feeling of phantom sensations or pain will also be recorded. Verbal reports will be collected at all in person sessions as well as phone follow us sessions. Analysis of these reports will include: the determination of the presence or absence of hand to face remapping, a detailed time course of onset and reversal if it occurs, specific locations of the hand-to-face remapping, changes in location of sensation reports prior to and following BPA, presence or absence of phantom limb sensations, such as the inability to feel limb repositioning, as well as the presence or absence of PLP. If PLP is experienced, scores of overall pain ratings will be conducted using a 10-cm visual analogue scale composed of a linear line where one end is labeled "no pain" and the other end is labeled "worst pain possible."
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPA Patients | – | Drug: brachial plexus anesthesiaParticipants that are receiving brachial plexus anesthesia for a previously planned shoulder surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient already receiving BPA as a part of a previously planned shoulder surgery
Key inclusion criteria (4 listed)
- Male or female subjects receiving brachial plexus anesthesia prior to upper extremity surgery
- Age 18 years or greater
- Ability to undergo 5-10 minutes of testing for multiple sessions: before anesthesia, following anesthesia but before surgery, following surgery while anesthesia remains effective, and throughout return of normal sensation
- Likely to complete all required sessions
Key exclusion criteria (2 listed)
- Age less than 18 years old
- Physical or mental health condition which may interfere with being able to complete all required sessions
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 |
|---|---|---|
| brachial plexus anesthesiaAnesthesia to some part of the brachial plexus prior to surgery. Patients are already receiving this regardless of participation in study. | Drug | BPA Patients |
Primary outcome
Verbal Report
Time frame: 3 days
descriptions of sensations
1 secondary outcome
Visual analog scale
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Limb and Brachial Plexus Block, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack W Tsao, MD, DPhil (9012876326, jtsao@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Report (time frame: 3 days). 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 23 Jul 2018.