NCT03088371

Brief Summary

Objectives: To compare the efficacy of continuous combined psoas sciatic block as a sole anaesthetic technique with conventional combined spinal epidural anesthesia for patients undergoing total knee arthroplasty. Subjects and Method: Eighty patients ASA (American society of anaesthesiologists classification) I to III with age range from 50 to 65 years old and scheduled for total knee replacement were included in the study. Subjects were divided into two groups; the first group (Pso/sci) received ultrasound guided with the use of nerve locator continuous psoas sciatic block and the second group (CSE) received combined spinal epidural anesthesia. Onset of sensory and motor block time, hemodynamic changes, contra-lateral spread, first time need for analgesia, incidence of complications, and patient and surgeon satisfactions were recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable knee-osteoarthritis

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

April 10, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

March 13, 2017

Last Update Submit

November 20, 2017

Conditions

Knee Osteoarthritis

Keywords

Total knee replacementPsoas Sciatic blockEpidural anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory block

    Duration of the sensory block is the time from the onset of the block to the first call of analgesia (minutes).

    24 hours post-operative.

Secondary Outcomes (5)

  • Mean arterial blood pressure

    Intra-operative

  • Heart rate

    Intra-operative.

  • Time of mobilisation

    24 hours post-operative.

  • Patients' satisfaction questionnaire

    Peri-operative

  • Surgeons' satisfaction questionnaire

    Peri-operative

Study Arms (2)

Psoas Sciatic blockade

OTHER

Psoas Sciatic blockade with 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% pajunk needle used for the block and 5 ml Lidocaine 2% used for post-operative pain.

Drug: Bupivacaine 0.25%Other: Pajunk NeedleDrug: Lidocaine 1%Drug: Lidocaine 2 %

Combined spinal epidural

OTHER

Spinal anaesthesia with 2.5 ml (12.5 mg) of heavy Bupivacaine 0.5%. Epidural for post-operative pain with Bupivacaine 0.125 %in a rate of 7-10 ml/hour Portex combined spinal epidural kit needle through needle.

Other: Portex combined spinal epidural kitDrug: Bupivacaine 0.5%Drug: Lidocaine 2 %Drug: Bupivacaine 0.125 %

Interventions

Bupivacaine 0.25%DRUG

For psoas sciatic block.

Also known as: Bupivacaine
Psoas Sciatic blockade
Pajunk NeedleOTHER

For local anaesthesia application in psoas sciatic block

Psoas Sciatic blockade
Portex combined spinal epidural kitOTHER

For combined spinal epidural anaesthesia

Combined spinal epidural
Lidocaine 1%DRUG

For psoas sciatic block.

Also known as: Lidocaine
Psoas Sciatic blockade
Bupivacaine 0.5%DRUG

For spinal anaesthesia in combined spinal epidural anaesthesia.

Also known as: Bupivacaine
Combined spinal epidural
Lidocaine 2 %DRUG

For psoas sciatic block in the post-operative period

Also known as: Lidocaine
Combined spinal epiduralPsoas Sciatic blockade
Bupivacaine 0.125 %DRUG

For combined spinal epidural in the post-operative period.

Also known as: Bupivacaine
Combined spinal epidural

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing total knee arthroplasty with ASA I, II, or III.

You may not qualify if:

  • Patients refusal, allergy to drugs used, and uncooperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 23, 2017

Study Start

April 10, 2014

Primary Completion

June 14, 2016

Study Completion

September 22, 2016

Last Updated

November 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share