Minimum Effective Dose of Local Anaesthetic With Fentanyl Clinical Trial
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.
| Verified date | February 2015 |
| Source | Cork University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ireland: Ministry of Health |
| Study type | Observational |
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:
1. 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:
2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative
fixation of fractured neck of femur.
3. The effect on haemodynamic variables (blood pressure, heart rate).
4. Incidence of side effects
5. The length of postoperative analgesia (the time from the last dose of local anaesthetic
administered intrathecally to VAS>3).
6. 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.
| Status | Completed |
| Enrollment | 33 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - fractured neck of femur - Above 60 years - American Society of Anesthetists(ASA) I to III Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Cork University Hospital | Cork |
| Lead Sponsor | Collaborator |
|---|---|
| Cork University Hospital |
Ireland,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence of side effects. | Patients will be interviewed 24-48 hours after surgery regarding side effects of spinal anaesthesia (headache, pruritus,postoperative nausea and vomiting,urinary retention,neurological deficit) | 24-48 hours | No |
| Other | The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3). | The time from the last top up of local anaesthetic to VAS >3 and to the first dose of break through analgesia will be recorded. | 1-2 hours | No |
| Primary | 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. | 15min | No |
| Secondary | 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. | Duration of surgery. | No |
| Secondary | 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. | Duration of surgery. | No |