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Postoperative AnalgesiaEarly Phase 1CTRTIKANCT03021421

Comparison of Two Regional Technics In Knee Artroplasty

A Early Phase 1 study testing intratechal (subarachnoidal )injection and lombar plexus and sciatic nerve injection in people with Postoperative Analgesia and Anesthesia; Functional, run by Ordu University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: This prospective, randomised, controlled, single-blind, multicentre study was designed to investigate the effects of peripheral nerve block methods (applied using unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee arthroplasty) on perioperative haemodynamic parameters and… Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
intratechal (subarachnoidal )injection and lombar plexus and sciatic nerve injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2015to Jul 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 50-80 age patients who have gonarthrosis

Who cannot join

  • under 50 year
  • above 80 years
  • and who have local anaesthetic allergy

About this study

Official title: The Effect of Unilateral Spinal Anaesthesia and Psoas Compartment With Sciatic Block on the Postoperative Pain Management in Total Knee Artroplastic Surgery

Purpose: This prospective, randomised, controlled, single-blind, multicentre study was designed to investigate the effects of peripheral nerve block methods (applied using unilateral spinal anaesthesia [USA] on elderly patients scheduled to undergo total knee arthroplasty) on perioperative haemodynamic parameters and the postoperative analgesia period.

Materials and Methods: Sixty patients in the American Society of Anesthesiologists (ASA) Physical Status II-III group were randomly divided into two groups. Spinal anaesthesia was performed in the USA group, in the lateral position through the intervertebral space, with 2 ml of hyperbaric bupivacaine (L4-L5 or L3-L4); 0.5% bupivacaine hydrochloride and 2% lidocaine were combined for the psoas compartment-sciatic (PCS) group, and the mixture was used for psoas compartment block (PCB) and sciatic nerve block. The haemodynamic parameters were recorded every 5 minutes until the end of the preoperative and perioperative operation periods and postoperative first analgesic application time.

Read the detailed description

In this prospective, randomised, multicentric and single-blind study, 60 patients who were diagnosed with gonarthrosis in the outpatient clinic of Ordu University Training Hospital and Ordu State Hospital between January 1, 2015 and June 30, 2015, and planned for total knee arthroplasty, were included. Patients who were allergic to local anaesthetics, had neurological disease, had infections in the intervention area, did not cooperate, or did not agree to the intervention were excluded from the study. After receiving informed consent from the patients, they were divided into two groups using the closed envelope method: the USA Group was the spinal anaesthesia (SA) group (n = 30), and the PCS group was the PCB and sciatic nerve block group (n = 30). All of the patients planned for surgery were monitored in terms of non-invasive arterial blood pressure, heart rate (HR) and peripheral haemoglobin oxygen saturation (SpO2). Peripheral vascular access was established using an 18-G cannula before the block operation, and 500 ml of 0.9% NaCl solution was infused for 20 minutes followed by the intravenous administration of 0.07 mg/kg midazolam (Dormicum®; Roche, Basel, Switzerland). The haemodynamic parameters were recorded every 5 minutes until the end of the preoperative and perioperative operation period. Next, 2 ml of hyperbaric bupivacaine hydrochloride (Marcain Heavy 0.5%; AstraZeneca®, London, UK) was administered to patients in the USA group in the lateral decubitus position, after regional sterilisation, through the selected intervertebral space (L4-L5 or L3-L4) using a 25-G Quincke spinal injector (B. Braun®, Melsungen, Germany). After remaining in this position for 15 minutes after the procedure, the patients were changed to the supine position. Patients in the PCS group were changed to the lateral decubitus (Simms) position. Following the sterilisation and covering procedures required for blockade of the lumbar plexus somatic nerves, the abdominal settings were selected on the ultrasound device (Mindray DC-T6 VET®, Shenzhen, China). The depth was set at 11-12 cm, and the frequency was set at 4-8 MHz. A convex ultrasonography (USG) probe was placed 4 cm laterally on the middle line at the L3-L5 level. The transverse process was longitudinally identified using an USG probe. The 'trident sign' (three-pronged spear appearance) acoustic shadow of the transverse process is characteristic. After viewing the psoas muscle at the depth of the transverse process, the needle was inserted using an out-plane approach. While using a nerve stimulator simultaneously (Stimupleks A; B. Braun®, Melsungen AG, Germany), the stimulation current was reduced to the 0.5-1.0 mA level when contraction of the quadriceps muscle was observed, and 20 ml of local anaesthetic (5 ml of 2% lidocaine + 15 ml of 0.5% bupivacaine) was injected. The local anaesthetic was observed to disperse around the lumbar plexus with USG. Sciatic nerve block was applied as follows: the patients' positions were not changed, and the skin was disinfected in the same position (lateral decubitus position). Following the required covering process, the USG settings were applied for optimum visualisation. The depth was set as 3-6 cm, and frequency as 2-8 MHz. The convex USG probe was placed in the subgluteal area in the transverse position. After determining the sciatic nerve, the injector was inserted into the lateral edge of the probe as in-plane and proceeded towards the nerve. When using the nerve stimulator simultaneously (Stimupleks A; B. Braun®), the stimulation current was reduced to 0.2-0.5 mA until contractions became visible. The local anaesthetic was observed to disperse around the sciatic nerve with USG by administering 20 ml of local anaesthetic (5 ml of 2% lidocaine + 15 ml of 0.5% bupivacaine) following negative aspiration with the injector. The patients were changed to the supine position. Surgery was allowed when effective sensory block reached with at least a T10 dermatome.

After the procedure, the patients were changed to the supine position. The application times of both techniques were recorded as the technique application times. While the analgesia level was evaluated using the pinprick test, the degree of motor block was assessed using the modified Bromage scale (0: no block, 1: hip flexion is blocked when the knee is extended, 2: knee flexion is blocked, 3: full motor block). Additionally, the sensory and motor blocks were evaluated at 5-minute intervals using the measurements of the haemodynamic parameters after the administration of medications. No case was excluded from the study because of block failure; thus, the data of all the cases in both groups were analysed.

Surgical intervention was initiated after the development of a full motor block. The time from the beginning of surgical incision until the completion of the procedure was recorded as the operation period. A decrease in the mean basal arterial pressure of 25% or more was considered as hypotension; in this case, ephedrine was administered as 5 mg intravenously (i.v.), and 5 ml/kg additional crystalloid fluid was given. Heart rates less than 50 beats/minute were considered as bradycardia, and atropine was administered as 0.5 mg i.v. All of the patients were administered 3 l/minute O2 through the mask and 5 ml/kg/hour maintenance crystalloid i.v. fluid during the surgery. The motor block return time and first analgesic requirement time were recorded.

Being tested
intratechal (subarachnoidal )injection, lombar plexus and sciatic nerve injection
Keywords
Total knee arthroplasty, unilateral spinal anaesthesia, psoas compartment block, sciatic nerve block, haemodynamic effects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intratechal (subarachnoidal )injectionProcedure or surgery

    Also called Marcaine Spinal 0,5 % Heavy ampule

    10 mg (2 cc) intrathecal single shot injection

  • lombar plexus and sciatic nerve injectionProcedure or surgery

    Also called Marcaine %0,5 20 cc flacon and Aritmal %2 ampule

    USG -guided lumbar plexus visualised and 20 ml local anaesthetic mixture (15 cc %0,5 Bupivacaine Hydrochloride 5 cc and %2 Lidocaine 5 cc ) for lombar plexus single shot injection

Study groups in NCT03021421
Study groupRoleWhat they receive
Group USASham comparator(Marcain Heavy 0.5%; AstraZeneca®, London, UK) using a 25-G Quincke spinal injector (B. Braun®, Melsungen, Germany).
Receives: Procedure: intratechal (subarachnoidal )injection
Group PCSActive comparator(Stimupleks A; B. Braun®, Melsungen AG, Germany) to lumbar plexus in psoas muscle compartment (injected material 20 ml local anaesthetic mixture5 ml of 2% lidocaine + 15 ml of 0.5% bupivacaine) %2 Aritmal ampul (Osel İlaç,Turkey) and Marcaine %0.5 flacon (AstraZeneca®, London, UK)
Receives: Procedure: lombar plexus and sciatic nerve injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative VAS values

    Visual Analog Scale (mm)

    Measured: postoperative first 24 hour

Secondary outcomes (2)
  1. Perioperative Heart Rate

    Beat to beat variability

    Measured: perioperative 150 minute

  2. Perioperative Mean Arterial Pressure

    mmHg

    Measured: perioperative 150 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03021421
Sponsor's protocol ID
OrduU
Acronym
CTRTIKA
Status last verified
Jan 2017
First submitted
19 Feb 2016
Last updated
13 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Canakci E, Unal D, Guzel Y. The Effect of Unilateral Spinal Anaesthesia and Psoas Compartment with Sciatic Block on the Postoperative Pain Management in Total Knee Artroplastic Surgery. Pain Res Manag. 2017;2017:4127424. doi: 10.1155/2017/4127424. Epub 2017 Jan 31.

    PubMed 28255259

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing intratechal (subarachnoidal )injection and lombar plexus and sciatic nerve injection in people with Postoperative Analgesia and Anesthesia; Functional, run by Ordu University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative VAS values (time frame: postoperative first 24 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.

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