Postoperative PainNCT01449318
Predictors of Postoperative Pain
A study testing Thermal Sensory Analyzer (Senselab) in people with Postoperative Pain, run by American University of Beirut Medical Center at 2 sites in Lebanon.
Trial summary
The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Thermal Sensory Analyzer (Senselab)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesLebanon
- Study dates
- Jul 2012to Mar 2014
- Phase
- Interventional
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing abdominal hysterectomy through a pfannenstiel incision
- American Society of Anesthesiologists (ASA)Class I-III
Who cannot join
- Patients with a history of psychiatric disease
- Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
- chronic opioid or nonsteroidal antiinflammatory drug use
- chronic pain conditions
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Predictors of Postoperative Pain Following Abdominal Hysterectomy
The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.
Read the detailed description
Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.
- Conditions
- Postoperative Pain
- Being tested
- Thermal Sensory Analyzer (Senselab)
- Keywords
- Pain, quantitative sensory testing
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Sensory Analyzer (Senselab)Device
Also called Modular Sensory Analyzer, Senselab
Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site.
To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C.
To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing hysterectomy | No intervention | Not described Receives: Device: Thermal Sensory Analyzer (Senselab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores from IV insertion
Measured: 15 minutes prior to induction
Secondary outcomes (7)
Anxiety
Measured: 24 to 48 hours before surgery
Pain from thermal stimuli
Pain from thermal stimuli will be measure at two sites: site of surgery and at the forearm.
Measured: 24 to 48 hours before surgery
Suprathreshold Thermal pain intensity
Suprathreshold Thermal pain intensity will be recorded at two site: site of surgery and forearm
Measured: 24 to 48 hours before surgery
suprathreshold thermal unpleasantness intensity
Measured: 24 to 48 hours before surgery
Expectation about pain
Measured: 24 to 48 hours before surgery
postoperative pain
Postoperative pain will be measured upon arrival to the Post Anesthesia Care Unit (PACU)before morphine consumption and after morphine consumption, at rest and at movement.
Measured: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
Morphine consumption
Measured: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 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 Oct 2011 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie T Aouad, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449318
- Sponsor's protocol ID
- ANES.MA.13
- Other IDs
- AUBMC
- Status last verified
- Sep 2013
- First submitted
- 28 Sep 2011
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Postoperative Pain Following Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01449318
- Acronym / sponsor ID
- ANES.MA.13
- Conditions
- Postoperative Pain
- Keywords
- Pain, quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Oct 2011 (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.
The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.
Detailed description
Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing hysterectomy | No intervention | Device: Thermal Sensory Analyzer (Senselab) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing abdominal hysterectomy through a pfannenstiel incision
- American Society of Anesthesiologists (ASA)Class I-III
Key exclusion criteria (4 listed)
- Patients with a history of psychiatric disease
- Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
- chronic opioid or nonsteroidal antiinflammatory drug use
- chronic pain conditions
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 |
|---|---|---|
| Thermal Sensory Analyzer (Senselab)Also: Modular Sensory Analyzer, SenselabThermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site. To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C. To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C). | Device | Patients undergoing hysterectomy |
Primary outcome
pain scores from IV insertion
Time frame: 15 minutes prior to induction
7 secondary outcomes
Anxiety
Time frame: 24 to 48 hours before surgery
Pain from thermal stimuli
Time frame: 24 to 48 hours before surgery
Suprathreshold Thermal pain intensity
Time frame: 24 to 48 hours before surgery
suprathreshold thermal unpleasantness intensity
Time frame: 24 to 48 hours before surgery
Expectation about pain
Time frame: 24 to 48 hours before surgery
postoperative pain
Time frame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
Morphine consumption
Time frame: within 1-2 hours after arrival to recovery room; and at 12 hours, 24 hours, 36 hours and 48 hours after surgery
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 16 May 2014.
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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.
Marie T Aouad, MD principal investigator
American University of Beirut Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Sensory Analyzer (Senselab) in people with Postoperative Pain, run by American University of Beirut Medical Center at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. 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.
What does the primary outcome measure?
pain scores from IV insertion (time frame: 15 minutes prior to induction). 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 16 May 2014.