Complication of AnesthesiaNCT02041806
Assessing Peripheral Nerve Block Scoring Systems for Intra-Operative and Post-Operative Analgesia
An observational study of Complication of Anesthesia, run by The Adelaide and Meath Hospital at 1 site in Ireland.
Trial summary
The purpose of this study is to determine if Peripheral Nerve Block scoring systems are effective in predicting the achievement of intra-operative anaesthesia and post-operative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Anesthesia
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Jul 2013to Jun 2014
- 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: Patients undergoing orthopaedic or vascular surgery who would receive a peripheral nerve block as part of their care.
Who may be able to join
- American Society of Anesthesiologists Grade I-IV
Who cannot join
- Contraindications to regional anesthesia
- Language barrier
- Existence of neurologic disease affecting the operative site
- Severe psychiatric disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Tallaght Hospital
Dublin
Patrick Conroy, patrick.conroy@amnch.ie
About this study
Official title: The Effectiveness of Peripheral Nerve Block Scoring Systems in Predicting the Success of a Block for Intra-Operative and Post-Operative Analgesia
The purpose of this study is to determine if Peripheral Nerve Block scoring systems are effective in predicting the achievement of intra-operative anaesthesia and post-operative analgesia.
Read the detailed description
Upper and lower extremity surgery is particularly suited to regional anaesthesia. Peripheral nerve blocks (PNB) can produce surgical anaesthesia in less than 30 minutes. PNBs have been associated with early outcome improvements when surgery is conducted awake or with light sedation. These benefits include reduced nausea and vomiting, improved patient satisfaction and accelerated recovery room and hospital discharge. PNBs can also provide effective postoperative pain relief.
Currently there is no globally accepted standard by which to assess when surgical anaesthesia has been achieved following administration of PNBs. The decision as to when adequate surgical anaesthesia has been achieved and when surgery can then proceed is usually left to the discretion of the anaesthetist. The anaesthetist can assess nerve blockade though several motor and sensory function tests: cold, heat, touch and pinprick sensitivity. Several scoring systems have been described using these tests to estimate when surgical anaesthesia has been achieved but none have been independently validated outside of the original studies in which they have been described.
- Conditions
- Complication of Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of block assessment score
Measured: 30 mins post block completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of AnesthesiaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Adelaide and Meath Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Patrick Conroy, The Adelaide and Meath Hospital
- Investigators
- Patrick H Conroy, Principal investigator, The Adelaide and Meath Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041806
- Sponsor's protocol ID
- SS/2013/81
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Peripheral Nerve Block Scoring Systems in Predicting the Success of a Block for Intra-Operative and Post-Operative Analgesia
- ClinicalTrials.gov ID
- NCT02041806
- Acronym / sponsor ID
- SS/2013/81
- Conditions
- Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Adelaide and Meath HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 22 Jan 2014 (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 this study is to determine if Peripheral Nerve Block scoring systems are effective in predicting the achievement of intra-operative anaesthesia and post-operative analgesia.
Detailed description
Upper and lower extremity surgery is particularly suited to regional anaesthesia. Peripheral nerve blocks (PNB) can produce surgical anaesthesia in less than 30 minutes. PNBs have been associated with early outcome improvements when surgery is conducted awake or with light sedation. These benefits include reduced nausea and vomiting, improved patient satisfaction and accelerated recovery room and hospital discharge. PNBs can also provide effective postoperative pain relief.
Currently there is no globally accepted standard by which to assess when surgical anaesthesia has been achieved following administration of PNBs. The decision as to when adequate surgical anaesthesia has been achieved and when surgery can then proceed is usually left to the discretion of the anaesthetist. The anaesthetist can assess nerve blockade though several motor and sensory function tests: cold, heat, touch and pinprick sensitivity. Several scoring systems have been described using these tests to estimate when surgical anaesthesia has been achieved but none have been independently validated outside of the original studies in which they have been described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing orthopaedic or vascular surgery who would receive a peripheral nerve block as part of their care.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists Grade I-IV
Key exclusion criteria (5 listed)
- Contraindications to regional anesthesia
- Language barrier
- Existence of neurologic disease affecting the operative site
- Severe psychiatric disease
- Pregnancy
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
Predictive value of block assessment score
Time frame: 30 mins post block completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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.
Patrick H Conroy principal investigator
The Adelaide and Meath Hospital
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 Complication of Anesthesia, run by The Adelaide and Meath Hospital at 1 site in Ireland.
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 5 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 22 Jan 2014. 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 Ireland. 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 Patrick Conroy, MB (00353852785308, P_W_C@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of block assessment score (time frame: 30 mins post block completion). 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 22 Jan 2014.