Arthroplasty, Replacement, KneePhase 4NCT04768764
Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty
A Phase 4 study testing Ultrasound Guided Middle Adductor Canal Block, Ultrasound Guided Femoral Nerve Block. and Bupivacain in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia
- What is being tested?
- Ultrasound Guided Middle Adductor Canal Block, Ultrasound Guided Femoral Nerve Block. and Bupivacain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2021to 16 Apr 2022
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
- Patients whose operation has been successfully completed with spinal anesthesia
Who cannot join
- Refusal of the patient to work
- Patients under 18 years of age
- Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
- Those with known local anesthetic allergies
- Body mass index> 35 patient groups
- Skin infection at the injection site
Show all 12Show fewer
- Coagulopathy and use of anticoagulant therapy
- Uncontrolled diabetic patients
- Uncooperative patient
- Physiological and emotional lability
- Prolonged surgical intervention
- Patient with limitation of mobilization and movement before the operation, other than the operation reason
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Bozyaka Training and Research Hospital
Izmir, 35170
Zeki Tuncel Tekgül, Assoc. Prof., 05058554705, zekittekgul@yahoo.com
Elif Göktaş, MD
About this study
Official title: Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty In Terms Of Postoperative Pain Control And Early Mobilization
Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.
Read the detailed description
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll. Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group.Femoral block or middle adductor canal block will be applied to the patients.
Group1 (Group 1 Middle Adductor Canal Block) patients will be administered middle adductor canal block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
Group2 (Femoral Nerve Block) patients will be administered femoral block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
The selected block will be applied with USG behind the curtain after the operation.Patients will be taken to the postoperative recovery unit.Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Post-operatively, patients will receive 1mg/kg Tramadol when Numeric Rating Scale(NRS) > 3.The duration of the sensory and motor block and the mobilization of the patients will be recorded and compared.
0,2,4,6,8,12,24 of the patient pain scores at hour and 6 months, presence of sensory block and motor block, pain score when the patient is mobilized will be recorded.In addition, operation time, complications related to block, mobilization time, discharge day, and opioid need will be recorded.It will be recorded at what time the first opioid dose was administered after the block.
- Conditions
- Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia, Anesthesia, Conduction, Nerve Block
- Being tested
- Ultrasound Guided Middle Adductor Canal Block, Ultrasound Guided Femoral Nerve Block., Bupivacain, Spinal Anesthesia
- Keywords
- femoral nerve block, adductor block, knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Middle Adductor Canal BlockProcedure or surgery
Also called Regional Anesthesia
Middle adductor canal block will be applied post-operatively with guidance of USG.
Drug:Bupivacaine 0.25% Injectable Solution
Ultrasound Guided Femoral Nerve Block.Procedure or surgery
Also called Regional Anesthesia
Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution
BupivacainDrug
Also called Marcain
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution
Spinal AnesthesiaProcedure or surgery
Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Middle Adductor Canal Block | Active comparator | Ultrasound Guided Middle Adductor Canal Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Receives: Procedure: Ultrasound Guided Middle Adductor Canal Block; Drug: Bupivacain; Procedure: Spinal Anesthesia |
| Group 2 Femoral Nerve Block. | Active comparator | Ultrasound Guided Femoral Nerve Block:
20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Receives: Procedure: Ultrasound Guided Femoral Nerve Block.; Drug: Bupivacain; Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 0th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 0th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 2nd hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 2nd hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 4th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 4th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 6th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 6th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 8th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 8th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 12th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 12th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 24th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 24th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: At 6 months postoperatively
Post-operative pain assessed by Numeric Rating Scale(NRS)
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Measured: At 6 months postoperatively
Ambulation time
First time a patients can walk around independently
Measured: 48 hours postoperatively
NRS at Ambulation
NRS when first time a patients can walk around independently
Measured: 48 hours postoperatively
Secondary outcomes (3)
Time of First Rescue Opioid
When patient's pain score(NRS) is 3 or more.
Measured: 48 hours postoperatively
Time of Return of Sensory Block
Examined with Prick Test
Measured: 24 hours postoperatively
Time of Return of Motor Block
Examined with Examined with Holmenn Skalası
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start16 Apr 2021 (estimated)
- Primary completion16 Oct 2021 (estimated)
- Study completion16 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: the first group is adductor block and the second group is femoral block.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Göktaş, Bozyaka Training and Research Hospital
- Investigators
- Zeki Tuncel Tekgül, Study director, İzmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768764
- Sponsor's protocol ID
- elifgoktas
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty In Terms Of Postoperative Pain Control And Early Mobilization
- ClinicalTrials.gov ID
- NCT04768764
- Acronym / sponsor ID
- elifgoktas
- Conditions
- Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia, Anesthesia, Conduction, Nerve Block
- Keywords
- femoral nerve block, adductor block, knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Apr 2021 (estimated)
- Primary completion
- 16 Oct 2021 (estimated)
- Study completion
- 16 Apr 2022 (estimated)
- First posted
- 24 Feb 2021 (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.
Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.
Detailed description
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll. Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group.Femoral block or middle adductor canal block will be applied to the patients.
Group1 (Group 1 Middle Adductor Canal Block) patients will be administered middle adductor canal block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
Group2 (Femoral Nerve Block) patients will be administered femoral block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.
The selected block will be applied with USG behind the curtain after the operation.Patients will be taken to the postoperative recovery unit.Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Post-operatively, patients will receive 1mg/kg Tramadol when Numeric Rating Scale(NRS) > 3.The duration of the sensory and motor block and the mobilization of the patients will be recorded and compared.
0,2,4,6,8,12,24 of the patient pain scores at hour and 6 months, presence of sensory block and motor block, pain score when the patient is mobilized will be recorded.In addition, operation time, complications related to block, mobilization time, discharge day, and opioid need will be recorded.It will be recorded at what time the first opioid dose was administered after the block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- There are two groups: the first group is adductor block and the second group is femoral block.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Middle Adductor Canal Block | Active comparator | Procedure: Ultrasound Guided Middle Adductor Canal Block, Drug: Bupivacain, Procedure: Spinal AnesthesiaUltrasound Guided Middle Adductor Canal Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. |
| Group 2 Femoral Nerve Block. | Active comparator | Procedure: Ultrasound Guided Femoral Nerve Block., Drug: Bupivacain, Procedure: Spinal AnesthesiaUltrasound Guided Femoral Nerve Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
- Patients whose operation has been successfully completed with spinal anesthesia
Key exclusion criteria (12 listed)
- Refusal of the patient to work
- Patients under 18 years of age
- Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
- Those with known local anesthetic allergies
- Body mass index> 35 patient groups
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 |
|---|---|---|
| Ultrasound Guided Middle Adductor Canal BlockAlso: Regional AnesthesiaMiddle adductor canal block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution | Procedure or surgery | Group 1 Middle Adductor Canal Block |
| Ultrasound Guided Femoral Nerve Block.Also: Regional AnesthesiaFemoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution | Procedure or surgery | Group 2 Femoral Nerve Block. |
| BupivacainAlso: Marcain10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution | Drug | Group 1 Middle Adductor Canal Block, Group 2 Femoral Nerve Block. |
| Spinal AnesthesiaPatients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose. | Procedure or surgery | Group 1 Middle Adductor Canal Block, Group 2 Femoral Nerve Block. |
Primary outcome
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 0th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 0th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 2nd hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 2nd hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 4th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 4th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 6th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 6th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 8th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 8th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 12th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 12th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 24th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 24th hour postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 6 months postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale(NRS)
Time frame: At 6 months postoperatively
Pain scores will be recorded as reported by the patient while knee flexion according to NRS
Ambulation time
Time frame: 48 hours postoperatively
First time a patients can walk around independently
NRS at Ambulation
Time frame: 48 hours postoperatively
NRS when first time a patients can walk around independently
3 secondary outcomes
Time of First Rescue Opioid
Time frame: 48 hours postoperatively
Time of Return of Sensory Block
Time frame: 24 hours postoperatively
Time of Return of Motor Block
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- 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.
Zeki Tuncel Tekgül study director
İzmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound Guided Middle Adductor Canal Block, Ultrasound Guided Femoral Nerve Block. and Bupivacain in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Göktaş (05062073485, e.goktas44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain assessed by Numeric Rating Scale(NRS) (time frame: At 0th hour postoperatively). The study lists 18 primary outcomes in all. 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 24 Feb 2021.