NCT06489210

Brief Summary

Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3.1 years

First QC Date

June 20, 2024

Last Update Submit

July 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of intraoperative and postoperative pain in different groups after intervention

    pain severity levels via visual analogue scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient was asked to mark on this line where the intensity of the patient lies

    24 hours after operation

Study Arms (3)

popliteal block posterior approach group

ACTIVE COMPARATOR

through posterior approach ultrasound guided sciatic nerve block at popliteal fossa 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally

Procedure: popliteal block

popliteal block lateral approach group

ACTIVE COMPARATOR

ultrasound guided sciatic nerve block at popliteal fossa through lateral approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally

Procedure: popliteal block

poplitea block medial approach group

ACTIVE COMPARATOR

ultrasound guided sciatic nerve block at popliteal fossa through medial approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally

Procedure: popliteal block

Interventions

using ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally

poplitea block medial approach grouppopliteal block lateral approach grouppopliteal block posterior approach group

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status (PS) class I and II
  • weighing 70-85 kg,
  • undergoing elective below knee surgeries

You may not qualify if:

  • patients who refused to participate in the study
  • those having an allergy to local anesthetics
  • peripheral neuropathy, coagulopathy
  • diabetes mellitus
  • severe hepatic
  • renal impairment
  • infection, mass and crush injury or open wound at the nerve block site
  • patients receiving chronic analgesic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Egypt

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia, intensive care and pain management

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 5, 2024

Study Start

April 1, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations