Perioperative Analgesia for Total Hip Arthroplasty

Perioperative Analgesia for Total Hip Arthroplasty: Lumbar Plexus Block Using Shamrock Technique Versus Fascia Iliaca Block

This study is comparing the effect of lumbar plexus block and fascia iliaca block with general anesthesia to provide perioperative pain control and compare their effects on hemodynamics

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia
• Intervention / Treatment: Procedure: bupivacaine 0.5% with 1:200000 adrenaline

Detailed Description

Different groups receive different interventions at same time during study. patients were randomly allocated in two groups :

Group A: lumbar plexus block using shamrock technique by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.

Group B: Fascia iliaca block by 0.3 ml/kg of 0.5% bupivacaine with 1:200000 adrenaline.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assistant Lecturer
    • Cairo, Assistant Lecturer, Egypt, 002
      • Ahmed hashem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I-II and scheduled for elective total hip arthroplasty

Exclusion Criteria:

• Patients who refuse to participate.
• Local infection.
• Patients with coagulation defects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ultrasound guided lumbar plexus block; patients were recieved lumbar plexus block ultrasound guided by shamrock technique using 0.5% bupavacaine in a dose 0.3ml/kg	Procedure: bupivacaine 0.5% with 1:200000 adrenaline; regional anesthesia to block lumbar plexus for analgesia of lower limb
Active Comparator: ultrasound guided Fascia iliaca block; patients were received fascia iliaca block ultrasound guided using 0.5% bupoavacaine in a dose 0.3ml\kg	Procedure: bupivacaine 0.5% with 1:200000 adrenaline; regional anesthesia to block lumbar plexus for analgesia of lower limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of postoperative analgesia	each patient was assessed by visual analogue scale which consists of a 10 cm line with one end labelled "no pain" and the other end labelled "worst pain imaginable". The patient marks the line at the point that best describes the pain intensity	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare effects of both groups on mean arterial blood pressure	monitoring of blood pressure using non invasive blood pressure measurement in millimeter mercury	intraoperative and 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare their effects on heart rate (beat\minute)	monitoring of heart rate using pulse oximetry in beat\minute	intraoperative and 24 hours
Complication rate for procedures in the form of local anesthetic toxicity	observation of occurrence of local anesthetic toxicity as hypotension, seizures, bradycardia	Intraoperative monitoring

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: ahmed abd elraof, professor, faculty of medicine, anesthesia department; Study Chair: Ezz elden saleh, professor, faculty of medicine, anesthesia department; Study Director: sadek abdelmasih, lecturer, faculty of medicine, anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: ANET 8/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No