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.
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
- Conditions the study is for
- Postoperative Analgesia, Anesthesia; Functional
- What is being tested?
- intratechal (subarachnoidal )injection and lombar plexus and sciatic nerve injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
- Conditions
- Postoperative Analgesia, Anesthesia; Functional
- 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 group | Role | What they receive |
|---|---|---|
| Group USA | Sham 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 PCS | Active 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.
Postoperative VAS values
Visual Analog Scale (mm)
Measured: postoperative first 24 hour
Secondary outcomes (2)
Perioperative Heart Rate
Beat to beat variability
Measured: perioperative 150 minute
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.
- First posted13 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Canakci, Ordu University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Unilateral Spinal Anaesthesia and Psoas Compartment With Sciatic Block on the Postoperative Pain Management in Total Knee Artroplastic Surgery
- ClinicalTrials.gov ID
- NCT03021421
- Acronym / sponsor ID
- CTRTIKA / OrduU
- Conditions
- Postoperative Analgesia, Anesthesia; Functional
- Keywords
- Total knee arthroplasty, unilateral spinal anaesthesia, psoas compartment block, sciatic nerve block, haemodynamic effects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group USA | Sham comparator | Procedure: intratechal (subarachnoidal )injection(Marcain Heavy 0.5%; AstraZeneca®, London, UK) using a 25-G Quincke spinal injector (B. Braun®, Melsungen, Germany). |
| Group PCS | Active comparator | Procedure: lombar plexus and sciatic nerve injection(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) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between 50-80 age patients who have gonarthrosis
Key exclusion criteria (3 listed)
- under 50 year
- above 80 years
- and who have local anaesthetic allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intratechal (subarachnoidal )injectionAlso: Marcaine Spinal 0,5 % Heavy ampule10 mg (2 cc) intrathecal single shot injection | Procedure or surgery | Group USA |
| lombar plexus and sciatic nerve injectionAlso: Marcaine %0,5 20 cc flacon and Aritmal %2 ampuleUSG -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 | Procedure or surgery | Group PCS |
Primary outcome
Postoperative VAS values
Time frame: postoperative first 24 hour
Visual Analog Scale (mm)
2 secondary outcomes
Perioperative Heart Rate
Time frame: perioperative 150 minute
Perioperative Mean Arterial Pressure
Time frame: perioperative 150 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Derived from this study: PubMed 28255259Canakci 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.