Perioperative Analgesia for Total Hip Arthroplasty

NCT04670497 | Completed DMC

• 1 other identifier: ANET 8/2018
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare effects of both groups on mean arterial blood pressure

  intraoperative and 24 hours

Other Outcomes (2)

• compare their effects on heart rate (beat\minute)

  intraoperative and 24 hours

• Complication rate for procedures in the form of local anesthetic toxicity

  Intraoperative monitoring

Study Arms (2)

ultrasound guided lumbar plexus block

ACTIVE COMPARATOR

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

ultrasound guided Fascia iliaca block

ACTIVE COMPARATOR

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

Interventions

bupivacaine 0.5% with 1:200000 adrenaline PROCEDURE

regional anesthesia to block lumbar plexus for analgesia of lower limb

ultrasound guided Fascia iliaca block; ultrasound guided lumbar plexus block

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Ahmed hashem

Cairo, Assistant Lecturer, 002, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• ahmed abd elraof, professor

  faculty of medicine, anesthesia department

  STUDY CHAIR

• Ezz elden saleh, professor

  faculty of medicine, anesthesia department

  STUDY CHAIR

• sadek abdelmasih, lecturer

  faculty of medicine, anesthesia department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sealed opaque envelop
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at menoufia university hospital

Model Details: 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 Record Dates

• First Submitted: November 25, 2020
• First Posted: December 17, 2020
• Study Start: July 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)