Post-thoracotomy Shoulder PainNCT00373984
A Study of the Incidence of Post-Thoracotomy Shoulder Pain
An observational study of Post-thoracotomy Shoulder Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients undergoing chest surgery (thoracotomy) often develop shoulder pain after their operation despite epidural pain control of the incision. We plan to study the incidence of this phenomenon in our institution to determine whether there are patterns that may predict those persons at highest risk of developing this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thoracotomy Shoulder Pain
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Jan 2006
- 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
Who may be able to join
- All procedures requiring thoracotomy including video assisted thoracoscopic surgery (VATS) be included.
Who cannot join
- Age less than 18 years
- Inability to communicate in English
- surgery in a position other than lateral ie. supine
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, 200 Elizabeth St.
Toronto, Ontario, B3H 1V7
About this study
Patients undergoing chest surgery (thoracotomy) often develop shoulder pain after their operation despite epidural pain control of the incision. We plan to study the incidence of this phenomenon in our institution to determine whether there are patterns that may predict those persons at highest risk of developing this type of pain. Further, we hope to determine whether newer surgical techniques have an impact on the development of this type of pain.
Read the detailed description
Patients undergoing thoracic surgery often benefit from aggressive post-operative pain management including thoracic epidural analgesia (1). However, a significant number of patients develop shoulder tip pain (SP) refractory to epidural analgesia. The incidence of post-thoracotomy ISTP has been noted in association with treatment studies to be high, as much as 88% of patients having thoracotomy for lobectomy (2). The actual incidence of SP has not been systematically studied. We propose to prospectively study all thoracotomy patients for a period of six months. The goal of this study is to determine the incidence of post-thoracotomy SP and to identify predictive factors. Further, we hope to elucidate the incidence of SP associated with newer minimally invasive surgical procedures such as video-assisted thoracoscopic surgery for lobectomy. This will facilitate early identification of the patients most likely to benefit from treatment.
All procedures requiring thoracotomy including video assisted thoracoscopic surgery (VATS) be included. The following non-nominal information will be collected:1. demographic data- age, sex, BMI, 2. presence/absence and tip position of epidural catheter3. type of surgery and duration of surgery4. surgeon5. inta-operative analgesia6. epidural infusion and rate7. position and number of chest drains8. pain assessment9. co-morbid conditions- diabetes, hypertension, coronary artery disease, pulmonary disease (obstructive/restrictive), arthritis (rheumatoid/osteo)10. pre-existing pain conditions 11. treatment for ISTPPatients will be separated into two groups for assessment of SP. The two groups will consist of patients with functional epidural analgesia (group E) and those without epidural catheters or with non-functioning epidural catheters (group NE). Epidural catheter level will be determined using nerve stimulation (Tsui test) prior to induction of anesthesia. Upon arrival to the Post Anesthetic Care Unit (PACU), patients in group E will be assessed for incision pain and shoulder tip pain. Epidural catheter function will be assessed by pinprick testing to assess the function of the anesthetic. In patients experiencing incisional pain and in whom nerve stimulation indicates positioning of the epidural catheter in the epidural space (stimulation at 1.1-10 mA), 4 millilitres of 2% lidocaine will be infused through the epidural catheter. Incision pain and anesthetic level will be reassessed after 10 minutes. The catheter will be considered non-functional if no improvement in incisional pain is noted 10 minutes after infusion of the 2% lidocaine. Time 0 will be the time at which incisional pain is determined by pinprick testing to be absent. This may be immediately on arrival to PACU or 10 minutes after instillation of 2% lidocaine. Standard epidural infusions of bupivacaine 0.1% plus hydromorphone 0.015mg/ml or ropivacaine 0.1% will be continued. Management of SP will be at the discretion of the attending anesthesiologist and the Acute Pain Service. Patients will be followed daily until resolution of the SP or hospital discharge. Patients with ongoing ISTP at discharge will be followed by telephone weekly for 3 months or until the pain resolves, whichever is earlier. Patients in group NE will also be assessed for incision and shoulder tip pain upon arrival to the PACU. VAS and VRS will be obtained after the initial nursing assessment. This will be recorded as time 0. Patients will be asked to identify the area of greatest pain. They will then be asked specifically about shoulder tip pain. VRS and VAS scores will be recorded for 1) incision pain, 2) ipsilateral shoulder pain 3) contralateral shoulder pain and 4) area of greatest pain if different from 1,2and 3. Management of pain will be at the discretion of the anesthesiologist and the Acute Pain Service. Patients will be followed until the resolution of their pain or until discharge. Patients with ongoing SP at discharge will be followed by telephone weekly for three months or until the pain resolves, whichever is earlier.
- Conditions
- Post-thoracotomy Shoulder Pain
- Keywords
- shoulder, thoracotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy Shoulder PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Slinger, MD, Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373984
- Sponsor's protocol ID
- Shoulderpain
- Status last verified
- Oct 2013
- First submitted
- 7 Sep 2006
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Incidence of Post-Thoracotomy Shoulder Pain
- ClinicalTrials.gov ID
- NCT00373984
- Acronym / sponsor ID
- Shoulderpain
- Conditions
- Post-thoracotomy Shoulder Pain
- Keywords
- shoulder, thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2006 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing chest surgery (thoracotomy) often develop shoulder pain after their operation despite epidural pain control of the incision. We plan to study the incidence of this phenomenon in our institution to determine whether there are patterns that may predict those persons at highest risk of developing this type of pain. Further, we hope to determine whether newer surgical techniques have an impact on the development of this type of pain.
Detailed description
Patients undergoing thoracic surgery often benefit from aggressive post-operative pain management including thoracic epidural analgesia (1). However, a significant number of patients develop shoulder tip pain (SP) refractory to epidural analgesia. The incidence of post-thoracotomy ISTP has been noted in association with treatment studies to be high, as much as 88% of patients having thoracotomy for lobectomy (2). The actual incidence of SP has not been systematically studied. We propose to prospectively study all thoracotomy patients for a period of six months. The goal of this study is to determine the incidence of post-thoracotomy SP and to identify predictive factors. Further, we hope to elucidate the incidence of SP associated with newer minimally invasive surgical procedures such as video-assisted thoracoscopic surgery for lobectomy. This will facilitate early identification of the patients most likely to benefit from treatment.
All procedures requiring thoracotomy including video assisted thoracoscopic surgery (VATS) be included. The following non-nominal information will be collected:1. demographic data- age, sex, BMI, 2. presence/absence and tip position of epidural catheter3. type of surgery and duration of surgery4. surgeon5. inta-operative analgesia6. epidural infusion and rate7. position and number of chest drains8. pain assessment9. co-morbid conditions- diabetes, hypertension, coronary artery disease, pulmonary disease (obstructive/restrictive), arthritis (rheumatoid/osteo)10. pre-existing pain conditions 11. treatment for ISTPPatients will be separated into two groups for assessment of SP. The two groups will consist of patients with functional epidural analgesia (group E) and those without epidural catheters or with non-functioning epidural catheters (group NE). Epidural catheter level will be determined using nerve stimulation (Tsui test) prior to induction of anesthesia. Upon arrival to the Post Anesthetic Care Unit (PACU), patients in group E will be assessed for incision pain and shoulder tip pain. Epidural catheter function will be assessed by pinprick testing to assess the function of the anesthetic. In patients experiencing incisional pain and in whom nerve stimulation indicates positioning of the epidural catheter in the epidural space (stimulation at 1.1-10 mA), 4 millilitres of 2% lidocaine will be infused through the epidural catheter. Incision pain and anesthetic level will be reassessed after 10 minutes. The catheter will be considered non-functional if no improvement in incisional pain is noted 10 minutes after infusion of the 2% lidocaine. Time 0 will be the time at which incisional pain is determined by pinprick testing to be absent. This may be immediately on arrival to PACU or 10 minutes after instillation of 2% lidocaine. Standard epidural infusions of bupivacaine 0.1% plus hydromorphone 0.015mg/ml or ropivacaine 0.1% will be continued. Management of SP will be at the discretion of the attending anesthesiologist and the Acute Pain Service. Patients will be followed daily until resolution of the SP or hospital discharge. Patients with ongoing ISTP at discharge will be followed by telephone weekly for 3 months or until the pain resolves, whichever is earlier. Patients in group NE will also be assessed for incision and shoulder tip pain upon arrival to the PACU. VAS and VRS will be obtained after the initial nursing assessment. This will be recorded as time 0. Patients will be asked to identify the area of greatest pain. They will then be asked specifically about shoulder tip pain. VRS and VAS scores will be recorded for 1) incision pain, 2) ipsilateral shoulder pain 3) contralateral shoulder pain and 4) area of greatest pain if different from 1,2and 3. Management of pain will be at the discretion of the anesthesiologist and the Acute Pain Service. Patients will be followed until the resolution of their pain or until discharge. Patients with ongoing SP at discharge will be followed by telephone weekly for three months or until the pain resolves, whichever is earlier.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All procedures requiring thoracotomy including video assisted thoracoscopic surgery (VATS) be included.
Key exclusion criteria (3 listed)
- Age less than 18 years
- Inability to communicate in English
- surgery in a position other than lateral ie. supine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Peter Slinger, MD principal investigator
Anesthesiologist
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 Post-thoracotomy Shoulder Pain, run by University Health Network, Toronto at 1 site in Canada.
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 3 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 Oct 2013. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 8 Oct 2013.