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Psoas Sciatic Blockade for Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bupivacaine 0.25%
Pajunk Needle
Portex combined spinal epidural kit
Lidocaine 1%
Bupivacaine 0.5%
Lidocaine 2 %
Bupivacaine 0.125 %
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis focused on measuring Total knee replacement, Psoas Sciatic block, Epidural anaesthesia

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Psoas Sciatic blockade

    Combined spinal epidural

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Mean arterial blood pressure
    Mean arterial blood pressure (mmHg) was recorded for both groups
    Heart rate
    Heart rate (beats/minute) was recorded for both groups
    Time of mobilisation
    Time of mobilisation is the time after admission to the surgical word when the patient can get out of bed for more than 15 minutes with or without support.
    Patients' satisfaction questionnaire
    The patients were asked if they were happy with the procedure or not.
    Surgeons' satisfaction questionnaire
    The surgeons were asked if they were happy with the anaesthetic technique and if it was adequate for the surgical procedure or not.

    Full Information

    First Posted
    March 13, 2017
    Last Updated
    November 20, 2017
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03088371
    Brief Title
    Psoas Sciatic Blockade for Knee Arthroplasty
    Official Title
    Psoas Sciatic Blockade Could be a Sole Anaesthetic Technique for Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 10, 2014 (Actual)
    Primary Completion Date
    June 14, 2016 (Actual)
    Study Completion Date
    September 22, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    After approval of the ethics committee, department of anaesthesia, Menoufia university and written informed consent, 80 patients undergoing unilateral total knee arthroplasty were randomly allocated into two groups. The first group (40 patients) received continuous psoas compartment block combined with continuous sciatic block (Pso/Sci group) and the second group (40 patients) received combined spinal epidural anaesthesia (CSE group). All patients were between 50 and 65 years old with an American society of anaesthesiologists classification (ASA status) of I to III. Patients' exclusion criteria included contraindication of regional anesthesia, bleeding disorders, localized infection, neurological deficit, substance dependence, and uncooperative patients. Upon arrival to the operative theater patients were attached to the standard monitoring and an intravenous cannula was inserted. All patients received 1 - 2 mg midazolam for sedation before the blocks. Sciatic nerve blockade: The block was done under complete aseptic technique. The patient was positioned in the lateral recumbent position with the operative side up and the hips and knees were flexed. The greater trochanter, posterior superior iliac spine and sacral hiatus were palpated and marked. Curvilinear low frequency U/S probe 2-5 MHz, (Sonosite, M-Turbo, Sonosite Inc., USA) was used for scanning. The probe was placed transversely in the middle of the line connecting the greater trochanter and sacral hiatus. The hip joint and the ischial spine were seen as hyperechoic lines in the lateral and medial sides respectively and the sciatic nerve was appeared as a triangular or flattened hyperechoic structure under the gluteus maximus. Local infiltration with 1 ml lidocaine 2% with 27-gauge needle was done before introducing the 100 mm 18 gauge sterile insulating pajunk needle (PAJUNK, PlexoLong, Germany) for the block. The pajunk needle was connected to a nerve stimulator (Plexygon, Vygon Italia, Padua, Italy) with 0.8 mA initial current and inserted out of plane reaching the sciatic nerve until eliciting either planter flexion or dorsiflexion with reduced current output up to 0.2 mA. A mixture of 15 ml lidocaine 1% and 15 ml bupivacaine 0.25% were injected around the sciatic nerve. A multi-perforated reinforced catheter was inserted through the needle and advanced 5 cm distal to the needle tip to provide continuous infusion. The needle was removed and the catheter was fixed to the skin. Psoas compartment blockade: The block was done under complete aseptic technique. The patient was positioned in the lateral recumbent position with the operative side upper most and hip and knee were flexed. L4-5 space was identified and marked by a line passing between the iliac crest and vertebral column. The puncture point for the block was marked 5 cm lateral to the L4-5 space within the drawn line. Using curvilinear low frequency U/S probe 2-5 MHz, (Sonosite, M-Turbo, Sonosite Inc., USA) the area was scanned longitudinally starting from the sacrum and moving cranially to identify the 4th transverse process then turned transversally in a rocking manner laterally to the end of the transverse process. The skin at the site of entry was infiltrated with 1 ml lidocaine 2% using 27-gauge needle. A 100 mm 18 gauge insulating pajunk needle (PAJUNK, PlexoLong, Germany) connecting to a nerve stimulator (Plexygon, Vygon Italia, Padua, Italy) with 0.8 mA initial current was advanced from medial to lateral proximal to the transverse process of L4 then advanced caudally to it until eliciting the quadriceps femoris contraction. When the contraction was persisted with reduced current down to 0.2 mA, a mixture of 20 ml lidocaine 1% and 20 ml bupivacaine 0.25% were injected after repeated negative aspiration. A multi-perforated reinforced catheter was inserted through the pajunk needle and was advanced 5 cm distal to the needle tip. The needle was removed and catheter was fixed to the skin. Combined spinal epidural block: The patient was in the sitting position, L3-4 space was marked then the area was sterilized and draped. Local anaesthetic (LA) was applied in the track by 27 gauge needle with 5 ml Lidocaine 1%. With portex combined spinal epidural kit needle through needle (PORTEX, Smiths Medical ASD, Inc., USA), the epidural space was detected by loss of resistance technique with saline then 27 gauge 120 mm pencil point spinal needle passed through the epidural needle till perforating the dura and observing the cerebrospinal fluid, 2.5 ml (12.5 mg) of heavy bupivacaine 0.5% (Bupivacaine hydrochloride 0.5%, 5mg/ml, AstraZeneca) was injected. The needle was removed and the epidural catheter was advanced 4 cm distal to the needle tip and fixed to the skin. After block was done all the patients returned back to the supine position, the sensory block was assessed by cold perception using ice backs and the motor block was assessed by Bromage scale (3=no flexion of hip, knee and foot; 2=no flexion of hip and knee with foot flexion; 1=no flexion of hip with flexion of knee and foot; 0=full flexion of hip, knee and foot). Sensory and motor blocks were assessed every 10 minutes for 3 times. Bilateral assessment was done to detect epidural spread of local anesthetics. Failure to establish adequate sensory and motor blocks after 30 minutes, a failed block was considered and general anesthesia was induced if there were no contraindications and the patient was excluded from the study. In both groups, the time taken to finish the block was recorded. The onset of sensory and motor blocks were recorded which was defined as the time from finishing the blockade to the occurrence of the block. In the post-operative period, the duration of the sensory block for both groups was recorded which was defined as the time between the onset of the block and the asking for first analgesia. Once the patient experienced pain (VAS ≥ 3), a bolus of 5 ml Lidocaine 2 % was injected in both catheters in (pso/sci) group and epidural catheter in (CSE) group then continuous LA infusion was followed using a solution of 0.125 % Bupivacaine in a rate of 7-10 ml/hour according to the patient response. Heart rate and blood pressure were recorded every 5 minutes all through the procedures; bradycardia and hypotension were considered if the heart rate and the mean blood pressure were 30% below the starting baseline. Bradycardia was treated by IV 0.5 mg atropine and hypotension was managed by 10- 15 mg IV ephedrine. Intra- and post-operative side effects like bradycardia, hypotension, nausea and vomiting were recorded. Age, gender, weight, ASA class and duration of surgery (time from skin incision until skin closure) were recorded. Data was analyzed using SSPS software 12.0 (SSPS Inc., Chicago, IL, USA) and represented as mean ± standard deviation and p value less than 0.05 was considered to be statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Total knee replacement, Psoas Sciatic block, Epidural anaesthesia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psoas Sciatic blockade
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Combined spinal epidural
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine 0.25%
    Other Intervention Name(s)
    Bupivacaine
    Intervention Description
    For psoas sciatic block.
    Intervention Type
    Other
    Intervention Name(s)
    Pajunk Needle
    Intervention Description
    For local anaesthesia application in psoas sciatic block
    Intervention Type
    Other
    Intervention Name(s)
    Portex combined spinal epidural kit
    Intervention Description
    For combined spinal epidural anaesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 1%
    Other Intervention Name(s)
    Lidocaine
    Intervention Description
    For psoas sciatic block.
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine 0.5%
    Other Intervention Name(s)
    Bupivacaine
    Intervention Description
    For spinal anaesthesia in combined spinal epidural anaesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 2 %
    Other Intervention Name(s)
    Lidocaine
    Intervention Description
    For psoas sciatic block in the post-operative period
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine 0.125 %
    Other Intervention Name(s)
    Bupivacaine
    Intervention Description
    For combined spinal epidural in the post-operative period.
    Primary Outcome Measure Information:
    Title
    Duration of sensory block
    Description
    Duration of the sensory block is the time from the onset of the block to the first call of analgesia (minutes).
    Time Frame
    24 hours post-operative.
    Secondary Outcome Measure Information:
    Title
    Mean arterial blood pressure
    Description
    Mean arterial blood pressure (mmHg) was recorded for both groups
    Time Frame
    Intra-operative
    Title
    Heart rate
    Description
    Heart rate (beats/minute) was recorded for both groups
    Time Frame
    Intra-operative.
    Title
    Time of mobilisation
    Description
    Time of mobilisation is the time after admission to the surgical word when the patient can get out of bed for more than 15 minutes with or without support.
    Time Frame
    24 hours post-operative.
    Title
    Patients' satisfaction questionnaire
    Description
    The patients were asked if they were happy with the procedure or not.
    Time Frame
    Peri-operative
    Title
    Surgeons' satisfaction questionnaire
    Description
    The surgeons were asked if they were happy with the anaesthetic technique and if it was adequate for the surgical procedure or not.
    Time Frame
    Peri-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing total knee arthroplasty with ASA I, II, or III. Exclusion Criteria: Patients refusal, allergy to drugs used, and uncooperative patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Psoas Sciatic Blockade for Knee Arthroplasty

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