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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471025
Other study ID # E-18-1935
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2018
Est. completion date May 3, 2019

Study information

Verified date July 2020
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.


Description:

Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind observer, the block characteristics were evaluated and recorded .


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date May 3, 2019
Est. primary completion date May 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- undergoing elective hand, wrist and forearm surgery

Exclusion Criteria:

- hepatic or renal failure

- serious cardiac or pulmoner disease

- local or systemic infection

- sepsis

- coagulation disorder

- neurological, muscular or psychiatric disease

- body mass index (BMI) below 18.5 or above 35

- drug and substance abuse

- pregnancy

- refusal of regional anesthesia

- history of allergy to local anesthetics

- mental-motor retardation (inability to consent or assess the visual analog scale(VAS) pain score)

- preoperative long-term NSAIDs or opioid use.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
USG guided infraclavicular block
USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary block performance time teh sum of imaging and needling time during block application
Primary block success incidence of ( %) surgery with successful anesthesia during surgery
Secondary Sensory block onset time Sensory blockage was evaluated and graded; from lateral to the forearm, the volar face of the thumb, volar face of the 5th finger and lateral side of the hand back; for musculocutaneous, median, ulnar and radial nerves, respectively. Graduation was according to a previously validated 3-point scale using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), and 2 = anesthesia (patient cannot feel touch) before surgery
Secondary motor block onset time blockage was evaluated and graded; with elbow flexion, thumb abduction, thumb opposition, thumb adduction for musculocutaneous, radial, median, ulnar nerves respectively. Motor blockage graduation was also according to a (validated) 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis. before surgery
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