Minimum Effective Dose of Local Anaesthetic With FentanylNCT01922622
Minimum Effective Intrathecal Dose of Local Anaesthetic With Fentanyl for Fractured Neck of Femur(Dose Finding Study).
An observational study of Minimum Effective Dose of Local Anaesthetic With Fentanyl, run by Cork University Hospital at 1 site in Ireland.
Trial summary
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Minimum Effective Dose of Local Anaesthetic With Fentanyl
- How many people
- 33 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with fractured neck of femur undergoing surgical repair of their fracture
Who may be able to join
- fractured neck of femur
- Above 60 years
- American Society of Anesthetists(ASA) I to III
Who cannot join
- Patient refusal
- Outside Age Range
- Contraindications to spinal anaesthesia
- Head injury or other associated injuries
- Loss of consciousness and signs of acute coronary syndrome
- Mini-Mental Score < 25 (Appendix 2)
- Allergy to bupivacaine, lignocaine or fentanyl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Initial Minimum Effective Dose of 0.5% Bupivacaine With 20mcg of Fentanyl Via a Spinal Catheter for Operative Fixation of Fractured Neck of Femur.
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better cardiovascular stability.The minimum dose of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the operative fixation of FNF.We will use a previously well established Dixon and Massey "up-and-down method" to calculate initial MLAD in this prospective, observational trial.
Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on the side of FNF.
Read more
Outcomes
Primary outcome:
- Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF. Secondary outcomes:
- Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur.
- The effect on haemodynamic variables (blood pressure, heart rate).
- Incidence of side effects
- The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3).
- The time to first rescue analgesic requirement
Study Design Prospective, observational trial.
Study Size Based on the previously well established Dixon and Massey "up-and-down method"(10), we will recruit patients until a successful spinal block has been achieved in six consecutive patients who received a specific dose. This is the requirement to calculate the initial MLAD.
- Keywords
- minimum effective dose of local anaesthetic, spinal catheter, fractured neck of femur, a step up, step down methodology
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar hemiarthroplasty. | Group of patients who will stay in lateral position during whole surgery. | |
| Dynamic hip screw. | Group of patients who will be supine during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF
A blinded observer will assess the dermatome level of sensory blockade with an ice-cold test (ethyl-chloride spray) bilaterally after the injection of the local anaesthetic. Block assessment will be performed every 5min up to 15 min after completion of the initial intrathecal injection. Sensory block up to T10=positive result Sensory block below T10=negative result.
Measured: 15min
Secondary outcomes (2)
Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur
Initial dose and all top ups will be recorded and analysed in conjunction with the length of surgery and surgical procedure used to fix FNF.
Measured: Duration of surgery.
The effect on haemodynamic variables (blood pressure, heart rate).
Noninvasive automated blood pressure and heart rate measurements will be recorded before the spinal anaesthesia (baseline) and every three minutes after the end of local anesthetic injection until the end of surgery.Hypotension is defined as a decrease of more than 20% from the baseline systolic arterial blood pressure (SAP). Severe hypotension is defined as a decrease in SAP more than 30% of baseline value. Hypotension will be treated with IV boluses of ephedrine 6 mg if the heart rate is below 60/minutes or phenylephrine 100 mcg if the heart rate is above 60/minutes.The number of hypotensive episodes, a total amount of vasopressor administered, and the i.v. fluid infused will be recorded as well as duration of anaesthesia.
Measured: Duration of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Minimum Effective Dose of Local Anaesthetic With FentanylStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tomas hitka, Cork University Hospital
- Investigators
- Tomas Hitka, RA fellow, Principal investigator, Cork University HospitalGabriella Iohom, consultant, Study chair, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922622
- Sponsor's protocol ID
- ECM 4(qqqq)07/05/13
- Status last verified
- Feb 2015
- First submitted
- 12 Aug 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.
PubMed 15220175Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
PubMed 16632842Stocks GM, Hallworth SP, Fernando R, England AJ, Columb MO, Lyons G. Minimum local analgesic dose of intrathecal bupivacaine in labor and the effect of intrathecal fentanyl. Anesthesiology. 2001 Apr;94(4):593-8; discussion 5A. doi: 10.1097/00000542-200104000-00011.
PubMed 11379678Idowu OA, Sanusi AA, Eyelade OR. Effects of intrathecally administered fentanyl on duration of analgesia in patients undergoing spinal anaesthesia for elective caesarean section. Afr J Med Med Sci. 2011 Sep;40(3):213-9.
PubMed 22428515Sell A, Olkkola KT, Jalonen J, Aantaa R. Minimum effective local anaesthetic dose of isobaric levobupivacaine and ropivacaine administered via a spinal catheter for hip replacement surgery. Br J Anaesth. 2005 Feb;94(2):239-42. doi: 10.1093/bja/aei015. Epub 2004 Oct 29.
PubMed 15516345O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.
PubMed 19512869Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.
PubMed 17478453Hartwell BL, Aglio LS, Hauch MA, Datta S. Vertebral column length and spread of hyperbaric subarachnoid bupivacaine in the term parturient. Reg Anesth. 1991 Jan-Feb;16(1):17-9.
PubMed 2007099Egan TD, Kern SE, Muir KT, White J. Remifentanil by bolus injection: a safety, pharmacokinetic, pharmacodynamic, and age effect investigation in human volunteers. Br J Anaesth. 2004 Mar;92(3):335-43. doi: 10.1093/bja/aeh075.
PubMed 14970134Machata AM, Gonano C, Holzer A, Andel D, Spiss CK, Zimpfer M, Illievich UM. Awake nasotracheal fiberoptic intubation: patient comfort, intubating conditions, and hemodynamic stability during conscious sedation with remifentanil. Anesth Analg. 2003 Sep;97(3):904-908. doi: 10.1213/01.ANE.0000074089.39416.F1.
PubMed 12933427Hitka T, O'Sullivan J, Szucs S, Iohom G. Determination of the initial minimum effective dose of 0.5% bupivacaine with 20 mug of fentanyl for an operative fixation of fractured neck of femur: a prospective, observational trial. Minerva Anestesiol. 2021 Jul;87(7):766-773. doi: 10.23736/S0375-9393.21.15012-6. Epub 2021 Feb 16.
PubMed 33591143
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Initial Minimum Effective Dose of 0.5% Bupivacaine With 20mcg of Fentanyl Via a Spinal Catheter for Operative Fixation of Fractured Neck of Femur.
- ClinicalTrials.gov ID
- NCT01922622
- Acronym / sponsor ID
- ECM 4(qqqq)07/05/13
- Keywords
- minimum effective dose of local anaesthetic, spinal catheter, fractured neck of femur, a step up, step down methodology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Aug 2013 (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.
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better cardiovascular stability.The minimum dose of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the operative fixation of FNF.We will use a previously well established Dixon and Massey "up-and-down method" to calculate initial MLAD in this prospective, observational trial.
Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on the side of FNF.
Outcomes
Primary outcome:
- Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF. Secondary outcomes:
- Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur.
- The effect on haemodynamic variables (blood pressure, heart rate).
- Incidence of side effects
- The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3).
- The time to first rescue analgesic requirement
Study Design Prospective, observational trial.
Study Size Based on the previously well established Dixon and Massey "up-and-down method"(10), we will recruit patients until a successful spinal block has been achieved in six consecutive patients who received a specific dose. This is the requirement to calculate the initial MLAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar hemiarthroplasty. | – | –Group of patients who will stay in lateral position during whole surgery. |
| Dynamic hip screw. | – | –Group of patients who will be supine during surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with fractured neck of femur undergoing surgical repair of their fracture
Key inclusion criteria (3 listed)
- fractured neck of femur
- Above 60 years
- American Society of Anesthetists(ASA) I to III
Key exclusion criteria (7 listed)
- Patient refusal
- Outside Age Range
- Contraindications to spinal anaesthesia
- Head injury or other associated injuries
- Loss of consciousness and signs of acute coronary syndrome
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
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF
Time frame: 15min
A blinded observer will assess the dermatome level of sensory blockade with an ice-cold test (ethyl-chloride spray) bilaterally after the injection of the local anaesthetic. Block assessment will be performed every 5min up to 15 min after completion of the initial intrathecal injection. Sensory block up to T10=positive result Sensory block below T10=negative result.
2 secondary outcomes
Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur
Time frame: Duration of surgery.
The effect on haemodynamic variables (blood pressure, heart rate).
Time frame: Duration of 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 4 Feb 2015.
- Background: PubMed 15220175Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. No abstract available.
- Background: PubMed 16632842Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
- Background: PubMed 11379678Stocks GM, Hallworth SP, Fernando R, England AJ, Columb MO, Lyons G. Minimum local analgesic dose of intrathecal bupivacaine in labor and the effect of intrathecal fentanyl. Anesthesiology. 2001 Apr;94(4):593-8; discussion 5A. doi: 10.1097/00000542-200104000-00011.
- Background: PubMed 22428515Idowu OA, Sanusi AA, Eyelade OR. Effects of intrathecally administered fentanyl on duration of analgesia in patients undergoing spinal anaesthesia for elective caesarean section. Afr J Med Med Sci. 2011 Sep;40(3):213-9.
- Background: PubMed 15516345Sell A, Olkkola KT, Jalonen J, Aantaa R. Minimum effective local anaesthetic dose of isobaric levobupivacaine and ropivacaine administered via a spinal catheter for hip replacement surgery. Br J Anaesth. 2005 Feb;94(2):239-42. doi: 10.1093/bja/aei015. Epub 2004 Oct 29.
- Background: PubMed 19512869O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.
- Background: PubMed 17478453Casati A, Baciarello M, Di Cianni S, Danelli G, De Marco G, Leone S, Rossi M, Fanelli G. Effects of ultrasound guidance on the minimum effective anaesthetic volume required to block the femoral nerve. Br J Anaesth. 2007 Jun;98(6):823-7. doi: 10.1093/bja/aem100. Epub 2007 May 3.
- Background: PubMed 2007099Hartwell BL, Aglio LS, Hauch MA, Datta S. Vertebral column length and spread of hyperbaric subarachnoid bupivacaine in the term parturient. Reg Anesth. 1991 Jan-Feb;16(1):17-9.
- Background: PubMed 14970134Egan TD, Kern SE, Muir KT, White J. Remifentanil by bolus injection: a safety, pharmacokinetic, pharmacodynamic, and age effect investigation in human volunteers. Br J Anaesth. 2004 Mar;92(3):335-43. doi: 10.1093/bja/aeh075.
- Background: PubMed 12933427Machata AM, Gonano C, Holzer A, Andel D, Spiss CK, Zimpfer M, Illievich UM. Awake nasotracheal fiberoptic intubation: patient comfort, intubating conditions, and hemodynamic stability during conscious sedation with remifentanil. Anesth Analg. 2003 Sep;97(3):904-908. doi: 10.1213/01.ANE.0000074089.39416.F1.
- Derived from this study: PubMed 33591143Hitka T, O'Sullivan J, Szucs S, Iohom G. Determination of the initial minimum effective dose of 0.5% bupivacaine with 20 mug of fentanyl for an operative fixation of fractured neck of femur: a prospective, observational trial. Minerva Anestesiol. 2021 Jul;87(7):766-773. doi: 10.23736/S0375-9393.21.15012-6. Epub 2021 Feb 16.
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.
Tomas Hitka, RA fellow principal investigator
Cork University Hospital
Gabriella Iohom, consultant study chair
Cork University 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 Minimum Effective Dose of Local Anaesthetic With Fentanyl, run by Cork University 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 3 inclusion and 7 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 4 Feb 2015. 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?
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?
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF (time frame: 15min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922622, which also lists 11 linked publications.
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 4 Feb 2015.