Knee OsteoarthritisNCT03088371
Psoas Sciatic Blockade for Knee Arthroplasty
A study testing Bupivacaine 0.25%, Pajunk Needle and Portex combined spinal epidural kit in people with Knee Osteoarthritis, run by Menoufia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bupivacaine 0.25%, Pajunk Needle and Portex combined spinal epidural kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2014to 22 Sep 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty with ASA I, II, or III.
Who cannot join
- Patients refusal, allergy to drugs used, and uncooperative patients.
About this study
Official title: Psoas Sciatic Blockade Could be a Sole Anaesthetic Technique for Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Bupivacaine 0.25%, Pajunk Needle, Portex combined spinal epidural kit, Lidocaine 1%, Bupivacaine 0.5%
- Keywords
- Total knee replacement, Psoas Sciatic block, Epidural anaesthesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
Also called Bupivacaine
For psoas sciatic block.
Pajunk NeedleOther
For local anaesthesia application in psoas sciatic block
Portex combined spinal epidural kitOther
For combined spinal epidural anaesthesia
Lidocaine 1%Drug
Also called Lidocaine
For psoas sciatic block.
Bupivacaine 0.5%Drug
Also called Bupivacaine
For spinal anaesthesia in combined spinal epidural anaesthesia.
Lidocaine 2 %Drug
Also called Lidocaine
For psoas sciatic block in the post-operative period
Bupivacaine 0.125 %Drug
Also called Bupivacaine
For combined spinal epidural in the post-operative period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bupivacaine 0.25%; Other: Pajunk Needle; Drug: 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. Receives: Other: Portex combined spinal epidural kit; Drug: Bupivacaine 0.5%; Drug: Lidocaine 2 %; Drug: Bupivacaine 0.125 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours post-operative.
Secondary outcomes (5)
Mean arterial blood pressure
Mean arterial blood pressure (mmHg) was recorded for both groups
Measured: Intra-operative
Heart rate
Heart rate (beats/minute) was recorded for both groups
Measured: Intra-operative.
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.
Measured: 24 hours post-operative.
Patients' satisfaction questionnaire
The patients were asked if they were happy with the procedure or not.
Measured: Peri-operative
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.
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start10 Apr 2014
- Primary completion14 Jun 2016
- Study completion22 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ezzeldin Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088371
- Sponsor's protocol ID
- MenoufiaU2017
- Status last verified
- Nov 2017
- First submitted
- 13 Mar 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoas Sciatic Blockade Could be a Sole Anaesthetic Technique for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03088371
- Acronym / sponsor ID
- MenoufiaU2017
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee replacement, Psoas Sciatic block, Epidural anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 22 Sep 2016 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoas Sciatic blockade | Other | Drug: Bupivacaine 0.25%, Other: Pajunk Needle, Drug: Lidocaine 1%, Drug: Lidocaine 2 %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. |
| Combined spinal epidural | Other | Other: Portex combined spinal epidural kit, Drug: Bupivacaine 0.5%, Drug: Lidocaine 2 %, Drug: Bupivacaine 0.125 %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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total knee arthroplasty with ASA I, II, or III.
Key exclusion criteria (1 listed)
- Patients refusal, allergy to drugs used, and uncooperative patients.
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 |
|---|---|---|
| Bupivacaine 0.25%Also: BupivacaineFor psoas sciatic block. | Drug | Psoas Sciatic blockade |
| Pajunk NeedleFor local anaesthesia application in psoas sciatic block | Other | Psoas Sciatic blockade |
| Portex combined spinal epidural kitFor combined spinal epidural anaesthesia | Other | Combined spinal epidural |
| Lidocaine 1%Also: LidocaineFor psoas sciatic block. | Drug | Psoas Sciatic blockade |
| Bupivacaine 0.5%Also: BupivacaineFor spinal anaesthesia in combined spinal epidural anaesthesia. | Drug | Combined spinal epidural |
| Lidocaine 2 %Also: LidocaineFor psoas sciatic block in the post-operative period | Drug | Combined spinal epidural, Psoas Sciatic blockade |
| Bupivacaine 0.125 %Also: BupivacaineFor combined spinal epidural in the post-operative period. | Drug | Combined spinal epidural |
Primary outcome
Duration of sensory block
Time frame: 24 hours post-operative.
Duration of the sensory block is the time from the onset of the block to the first call of analgesia (minutes).
5 secondary outcomes
Mean arterial blood pressure
Time frame: Intra-operative
Heart rate
Time frame: Intra-operative.
Time of mobilisation
Time frame: 24 hours post-operative.
Patients' satisfaction questionnaire
Time frame: Peri-operative
Surgeons' satisfaction questionnaire
Time frame: Peri-operative
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 22 Nov 2017.
- Individual participant dataSharing planned: No
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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 study testing Bupivacaine 0.25%, Pajunk Needle and Portex combined spinal epidural kit in people with Knee Osteoarthritis, run by Menoufia 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 1 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 22 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Duration of sensory block (time frame: 24 hours post-operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2017.