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Clinical Trials/NCT01815372
NCT01815372
Completed
Not Applicable

Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique

Bispebjerg Hospital1 site in 1 country60 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Leg Surgery, e.g. Ankle Fractures
Sponsor
Bispebjerg Hospital
Enrollment
60
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jens Borglum Neimann

Consultant anesthetist, PhD, Ass. Professor

Bispebjerg Hospital

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
  • Nerve block contraindicated

Outcomes

Primary Outcomes

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.

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.

The time measurement is done with a normal clock - measuring seconds and minutes.

Secondary Outcomes

  • Pain score (VAS score 0-10).(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.)
  • Sensory dermatome testing.(Normally until 2 hours postoperatively.)

Study Sites (1)

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