Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
Primary Purpose
Lower Leg Surgery, e.g. Ankle Fractures
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Single penetration dual injection (SPEDI) block technique to block the sciatic and the saphenous nerve with one needle penetration of the skin
The classical popliteal sciatic nerve block combined with the mid-femoral saphenous nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Lower Leg Surgery, e.g. Ankle Fractures focused on measuring nerve blocks, ultrasound-guided, leg surgery
Eligibility Criteria
Inclusion Criteria:
- lower leg surgery
- American Society of Anesthesiologist (ASA) score I-III
- Can cooperate in the study
- Speaks and understand the Danish language
- General anesthesia
Exclusion Criteria:
- Intake of oral morphine above 40 mg per day
- Know allergy to ropivacaine
- Abuse of alcohol or other substance abuse
- Neuropathy
- Pregnant
- Nerve block contraindicated
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SPEDI
Popliteal sciatic and mid-femoral saphenous
Arm Description
These are the patients that will be randomized to receive a SPEDI block of the sciatic and saphenous nerve with at single needle penetration of the skin
These are the patients that will be randomized to the administration of a popliteal sciatic nerve block combined with a mid-femoral saphenous nerve block with two separate injections
Outcomes
Primary Outcome Measures
Performance time (seconds and minutes). Time measurement from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.
The time measurement is done with a normal clock - measuring seconds and minutes.
Secondary Outcome Measures
Pain score (VAS score 0-10).
Sensory dermatome testing.
Sensory dermatome testing is done with cold ethanol on skin test. All dermatomes on the leg and foot are tested, and there is a comparison of the outcome between the operated leg and the not-operated leg.
Full Information
NCT ID
NCT01815372
First Posted
November 26, 2012
Last Updated
November 5, 2013
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01815372
Brief Title
Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
Official Title
Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following leg surgery. Traditionally two separate injections are performed. The aim was to describe a novel, faster USG block combination requiring only one skin penetration to block the sciatic and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.
Methods: A randomized, controlled and double-blinded trial. Following ethics committee approval 60 patients will be randomized to the administration of an USG SPEDI block compared to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be performed after induction of general anaesthesia. Outcome measures will be performance time (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block difficulty level (easy, middle, difficult), opioid consumption (in the PACU), serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will be evaluated by MR imaging (MRI).
Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster without moving the leg, and achieve successful perioperative pain management. The SPEDI block may find important use in the emergency setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Leg Surgery, e.g. Ankle Fractures
Keywords
nerve blocks, ultrasound-guided, leg surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPEDI
Arm Type
Experimental
Arm Description
These are the patients that will be randomized to receive a SPEDI block of the sciatic and saphenous nerve with at single needle penetration of the skin
Arm Title
Popliteal sciatic and mid-femoral saphenous
Arm Type
Active Comparator
Arm Description
These are the patients that will be randomized to the administration of a popliteal sciatic nerve block combined with a mid-femoral saphenous nerve block with two separate injections
Intervention Type
Procedure
Intervention Name(s)
Single penetration dual injection (SPEDI) block technique to block the sciatic and the saphenous nerve with one needle penetration of the skin
Intervention Type
Procedure
Intervention Name(s)
The classical popliteal sciatic nerve block combined with the mid-femoral saphenous nerve block
Primary Outcome Measure Information:
Title
Performance time (seconds and minutes). Time measurement from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.
Description
The time measurement is done with a normal clock - measuring seconds and minutes.
Time Frame
The measurement (seconds and minutes) will take place in the operating room. This will normally be within a time frame of 1 minute to 10 minutes.
Secondary Outcome Measure Information:
Title
Pain score (VAS score 0-10).
Time Frame
When the patient are evaluated in the recovery unit upon arrival and when the patient is discharged from the recovery unit. This means from time 0 hours (arrival in the PACU) and normally until 2 hours after arrival in the PACU.
Title
Sensory dermatome testing.
Description
Sensory dermatome testing is done with cold ethanol on skin test. All dermatomes on the leg and foot are tested, and there is a comparison of the outcome between the operated leg and the not-operated leg.
Time Frame
Normally until 2 hours postoperatively.
Other Pre-specified Outcome Measures:
Title
Opioid consumption (micrograms of sufentanil) in total in the recovery unit.
Time Frame
Normally from 0 hours until 2 hours after arrival in the recovery unit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lower leg surgery
American Society of Anesthesiologist (ASA) score I-III
Can cooperate in the study
Speaks and understand the Danish language
General anesthesia
Exclusion Criteria:
Intake of oral morphine above 40 mg per day
Know allergy to ropivacaine
Abuse of alcohol or other substance abuse
Neuropathy
Pregnant
Nerve block contraindicated
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400 NV
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
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