NCT03607292

Brief Summary

Co-administration of the sciatic nerve block and femoral nerve block may provide anesthesia and analgesia in patients undergoing lower extremity surgery. Several approaches to sciatic nerve block have been described. The anterior and posterior approaches are two of the approaches used to make the sciatic nerve block. In our study, n = 20 patients for Group A and n = 25 patients for Group P were included. Then, sciatic nerve block and femoral nerve block were performed to each patient by using anterior or posterior approach randomly. After the block is performed, the sensory and motor block start and end times, the first intraoperative fentanyl requirement time and total amount of fentanyl required, the first Diclofenac sodium requirement time, and the total amount of diclofenac sodium that patients required were determined. As the groups were compared to each other; the time to start sensory block was statistically significantly lower, the first fentanyl requirement time was statistically significantly earlier and the total amount of fentanyl required was statistically significantly lower in Group P. Patient satisfaction, anesthesia quality and surgical quality were statistically significantly higher in Group P. In this study, the investigators concluded that if a patient does not have pain secondary to fracture, posterior approach to sciatic nerve block can be performed, whereas, if a patient has pain secondary to fracture, anterior approach to sciatic nerve block can be performed in order to avoid repositioning.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

June 11, 2018

Last Update Submit

July 30, 2018

Conditions

Keywords

Sciatic Nerve BlocksAnkle surgery

Outcome Measures

Primary Outcomes (1)

  • Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches.

    Sensory block was assessed with a cold application every minute, and the block start time was recorded. When the patient was not receiving any stimulation with cold application on sciatic stimulation area, it was recorded as the start time of the full sciatic sensory block.

    up to 20 minutes.

Secondary Outcomes (12)

  • Comparison of sensorial block end time after sciatic nerve block performed with anterior and posterior approaches.

    up to 300 minutes.

  • Comparison of sensorial block start time after femoral nerve block performed with anterior and posterior approaches.

    up to 20 minutes.

  • Comparison of sensorial block end time after femoral nerve block performed with anterior and posterior approaches.

    up to 160 minutes.

  • Comparison of patient satisfaction

    After surgery up to 24 hours.

  • Comparison of anesthesia quality in groups

    After surgery up to 24 hours.

  • +7 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Anterior sciatic nerve block

Procedure: Anterior sciatic nerve block

Group P

EXPERIMENTAL

Posterior sciatic nerve block

Procedure: Posterior sciatic nerve block

Interventions

A straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral. The sciatic nerve was imaged by USG along the needle route and the needle was advanced to the nerve.

Group A

Patient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, and a line was drawn 4 cm above the first line perpendicular to the caudal line. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve.

Group P

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were between the ages of 18 to 65 and were going to be operated due to lateral and/or medial malleolus fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
A single blinded anesthesiologist performed posterior or anterior sciatic nerve block and femoral block and left the operating room 'after the nerve block was completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomize, single blind, prospective
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 31, 2018

Study Start

March 18, 2013

Primary Completion

March 18, 2014

Study Completion

December 20, 2014

Last Updated

July 31, 2018

Record last verified: 2018-07