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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03394014
Other study ID # FMASU R46/2017
Secondary ID
Status Completed
Phase N/A
First received December 24, 2017
Last updated January 3, 2018
Start date January 1, 2017
Est. completion date July 1, 2017

Study information

Verified date January 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA


Description:

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:

- ASA physical status II and III patients

- aged 45-75 years,

- undergoing elective below knee amputation

Exclusion Criteria:

- patients who refused to participate in the study,

- those having allergy to local anaesthetics,

- or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
sciatic nerve block
blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary to compare between the two techniques as regards the success rate. Success was considered when the block provided solid analgesia with no need to shift to GA 24 hours
Secondary time taken to perform the block time required to perform either block 10-20 min
See also
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Completed NCT01568476 - Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time? N/A
Recruiting NCT06309381 - Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block.
Completed NCT03678961 - The Effect of Leg Position on the Sciatic Nerve on Sonogram
Completed NCT03442036 - Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks N/A
Not yet recruiting NCT03486548 - Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA Phase 4