Pain, PostoperativeNCT00176696
Biobehavioral Recovery From Surgery and Anesthesia
An observational study of Pain, Postoperative, run by University of Medicine and Dentistry of New Jersey.
Trial summary
Reducing postoperative pain leads to increased patient comfort and facilitates speedy recovery and discharge from the hospital following surgery. The focus of controlling postoperative pain has gradually shifted from postoperative management to intraoperative management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Use of FACE monitor and BIS monitor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Apr 2007
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects undergoing surgery
Who may be able to join
- Subjects 18-65 years of age
- Subjects who are English speaking
- Subjects undergoing surgery in the supine position
- Subjects who are undergoing a procedure where the surgical incision is expected to be at least 4 inches
- Subjects who are undergoing a surgical procedure below the level of their arms.
- Female subjects who have a negative Sure-Vue pregnancy test.
- Subjects who are undergoing surgery under general anesthesia.
Who cannot join
- If the scheduled surgery involves the head, neck or arms.
- Subjects who have a history of chronic pain
- Subjects who have cognitive disabilities secondary to medical, chemical and genetic causes.
- Subjects who have peripheral vascular disease of the arms.
- Subjects who have carpal tunnel syndrome.
- Subjects who have psychiatric, substance abuse and cognitive impairments
Show all 12Show fewer
- Subjects who have had a stroke which has affected function of the upper extremities
- Subjects who have had a mastectomy or other type of surgery which may have affected the lymph nodes of the arms
- Subjects who do not have a telephone
- Subjects who are having surgery under nerve block or regional anesthesia
- Subjects who are pregnant
- Subjects who have an electrical source, i.e. pacemaker or defibrillator
About this study
Official title: Detection of Nociception ("Pain") During General Anesthesia
Reducing postoperative pain leads to increased patient comfort and facilitates speedy recovery and discharge from the hospital following surgery. The focus of controlling postoperative pain has gradually shifted from postoperative management to intraoperative management. The investigators believe that this study is a unique opportunity to assess the adequacy of intraoperative analgesia, allowing for immediate administration of the appropriate opioid analgesics. The purpose of this research is to bring to light the applicability of facial electromyography as an intraoperative solution to postoperative pain management.
Read the detailed description
After consenting to enter the study, the subject will be asked a series of questions regarding his/her medical history. He/she will be shown the test for determining consciousness by squeezing the experimenter's hand when asked. It will be explained to him/her that once unconscious, he/she will not be able to respond to the command of squeezing the hand. The facial monitor will be shown to the patient, as well as its location of placement.
Intraoperative Period: The leads will be placed for the FACE monitor as well as for the BIS monitoring device. The objective of the BIS monitor which is already in use in the University Hospital Operating room suites is to determine consciousness. An identical and typical anesthetic protocol will be utilized for all the patients in order to eliminate anesthetic factors. The protocol is as follows:
After administration of propofol for induction, a forearm tourniquet device will be inflated to a pressure greater than 200 mm Hg. A muscle relaxant will then be given once the tourniquet is inflated while the arm with the tourniquet will not be paralyzed. This allows for a check on the unconsciousness of the patient; that is, the patient will be told, "squeeze my hand". It is expected that no patient will respond by squeezing his or her hand because they are unconscious and anesthetized. The maximum length of time the cuff will be inflated is 20 minutes. Tourniquets applied to the entire leg or arm are normally inflated for up to 120 minutes and are standard practice in orthopedic surgery.
One group of patients, determined randomly, will be administered 250 ug of fentanyl during induction of anesthesia, while the second group, also determined randomly, will be administered 50 ug of fentanyl. Both groups of patients will be administered an inhalational anesthetic (isoflurane, desflurane, or sevoflurane) at the level 30% above that which insures unconsciousness (called 1.1 MAC), but will not be given nitrous oxide during the 10 minutes of our study period due to this gas' effect on Hagihira's "loss of bicoherence" phenomenon.
The study period will begin 5 minutes before surgical incision, and will end 5 minutes after surgical incision. Our hypothesis is that central registration of pain exists despite the presence of adequate unconsciousness in the patient, and FACE technology will complement the use of the BIS (EEG) monitor to ensure effective administration of anesthesia for patients in the future.
- Conditions
- Pain, Postoperative
- Being tested
- Use of FACE monitor and BIS monitor
- Keywords
- general anesthesia, pain, depth of anesthesia
- 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.
Use of FACE monitor and BIS monitorDevice
Also called BIS (Bispectral Score)determines the depth of anesthesia
Face monitor records facial muscle activity
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of pain during general anesthesia
Measured: after induction of anesthesia
Secondary outcomes (1)
Visual analogue scale for first two days post anesthesia
Measured: 2 post op days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Principal Investigator has left the UMDNJ
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry L. Bennett, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176696
- Sponsor's protocol ID
- 0120050013
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2005
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Nociception ("Pain") During General Anesthesia
- ClinicalTrials.gov ID
- NCT00176696
- Acronym / sponsor ID
- 0120050013
- Conditions
- Pain, Postoperative
- Keywords
- general anesthesia, pain, depth of anesthesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator has left the UMDNJ
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Reducing postoperative pain leads to increased patient comfort and facilitates speedy recovery and discharge from the hospital following surgery. The focus of controlling postoperative pain has gradually shifted from postoperative management to intraoperative management. The investigators believe that this study is a unique opportunity to assess the adequacy of intraoperative analgesia, allowing for immediate administration of the appropriate opioid analgesics. The purpose of this research is to bring to light the applicability of facial electromyography as an intraoperative solution to postoperative pain management.
Detailed description
After consenting to enter the study, the subject will be asked a series of questions regarding his/her medical history. He/she will be shown the test for determining consciousness by squeezing the experimenter's hand when asked. It will be explained to him/her that once unconscious, he/she will not be able to respond to the command of squeezing the hand. The facial monitor will be shown to the patient, as well as its location of placement.
Intraoperative Period: The leads will be placed for the FACE monitor as well as for the BIS monitoring device. The objective of the BIS monitor which is already in use in the University Hospital Operating room suites is to determine consciousness. An identical and typical anesthetic protocol will be utilized for all the patients in order to eliminate anesthetic factors. The protocol is as follows:
After administration of propofol for induction, a forearm tourniquet device will be inflated to a pressure greater than 200 mm Hg. A muscle relaxant will then be given once the tourniquet is inflated while the arm with the tourniquet will not be paralyzed. This allows for a check on the unconsciousness of the patient; that is, the patient will be told, "squeeze my hand". It is expected that no patient will respond by squeezing his or her hand because they are unconscious and anesthetized. The maximum length of time the cuff will be inflated is 20 minutes. Tourniquets applied to the entire leg or arm are normally inflated for up to 120 minutes and are standard practice in orthopedic surgery.
One group of patients, determined randomly, will be administered 250 ug of fentanyl during induction of anesthesia, while the second group, also determined randomly, will be administered 50 ug of fentanyl. Both groups of patients will be administered an inhalational anesthetic (isoflurane, desflurane, or sevoflurane) at the level 30% above that which insures unconsciousness (called 1.1 MAC), but will not be given nitrous oxide during the 10 minutes of our study period due to this gas' effect on Hagihira's "loss of bicoherence" phenomenon.
The study period will begin 5 minutes before surgical incision, and will end 5 minutes after surgical incision. Our hypothesis is that central registration of pain exists despite the presence of adequate unconsciousness in the patient, and FACE technology will complement the use of the BIS (EEG) monitor to ensure effective administration of anesthesia for patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects undergoing surgery
Key inclusion criteria (7 listed)
- Subjects 18-65 years of age
- Subjects who are English speaking
- Subjects undergoing surgery in the supine position
- Subjects who are undergoing a procedure where the surgical incision is expected to be at least 4 inches
- Subjects who are undergoing a surgical procedure below the level of their arms.
Key exclusion criteria (12 listed)
- If the scheduled surgery involves the head, neck or arms.
- Subjects who have a history of chronic pain
- Subjects who have cognitive disabilities secondary to medical, chemical and genetic causes.
- Subjects who have peripheral vascular disease of the arms.
- Subjects who have carpal tunnel syndrome.
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 |
|---|---|---|
| Use of FACE monitor and BIS monitorAlso: BIS (Bispectral Score)determines the depth of anesthesiaFace monitor records facial muscle activity | Device | – |
Primary outcome
detection of pain during general anesthesia
Time frame: after induction of anesthesia
1 secondary outcome
Visual analogue scale for first two days post anesthesia
Time frame: 2 post op days
Results and safety
The study was stopped early (reason given: Principal Investigator has left the UMDNJ). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- 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.
Henry L. Bennett, PhD principal investigator
Rutgers, The State University of New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University of Medicine and Dentistry of New Jersey.
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 7 inclusion and 12 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Principal Investigator has left the UMDNJ). Results are not available in the source record.
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?
detection of pain during general anesthesia (time frame: after induction of anesthesia). 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 6 Oct 2016.