Post-operative AnalgesiakneesurgeryNCT06683313
Comparison of the Combination of Popliteal Sciatic and Femoral Block With the Combination of Ipack Adductor Canal Blocks
An observational study of Post-operative Analgesia and Early Mobility, run by Gaziosmanpasa Research and Education Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Comparison of the combination of popliteal sciatic and femoral block with the combination of ipack adductor canal blocks and mobilization and analgesia duration in elective knee surgeries Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-operative Analgesia, Early Mobility
- What is being tested?
- combination femoral nerve and popliteal sciatica block and combination adductor canal and IPACK block
- How many people
- 93 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Aug 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 75 who will undergo knee surgery
Who may be able to join
- -
- Exclusion Criteria:Patients who did not consent to the procedure, those with coagulopathy, a known allergy to local anesthetics, a BMI > 35 kg/m², chronic analgesic and opioid use, mental or psychiatric disorders, or inability -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gaziosmanpasa Research and Education Hospital, Istanbul, 34000
Istanbul, 34000
Gaziosmanpasa Research and Education Hospital, Istanbul, 34000
Istanbul, 34255
About this study
Official title: Comparison of the Combination of Popliteal Sciatic and Femoral Block With the Combination of Ipack Adductor Canal Block Duration in Elective Knee Surgeries
Comparison of the combination of popliteal sciatic and femoral block with the combination of ipack adductor canal blocks and mobilization and analgesia duration in elective knee surgeries
Read the detailed description
There is concern that about half of patients with elective knee surgery report severe knee pain immediately after surgery. Optimal postoperative knee analgesia is important not only for patient comfort and satisfaction, but also to accelerate mobilization, functional recovery, and hospital discharge. To facilitate earlier ambulation and provide superior pain control, while striving for shorter hospital stays and same-day discharge for patients There is an increasing emphasis on multimodal analgesia and motor sparing regional anesthesia blocks.
To compare the postoperative analgesic efficacy of ipack adductor canal and femoral popliteal sciatic blocks in elective knee surgeries, and the first mobilization (bromage 0) times of motor block after spinal anesthesia. Our primary aim is to compare the ipack adductor canal block added after spinal anesthesia in elective knee surgeries with the combination of femoral + popliteal sciatic block. post of blocks To evaluate the operative mobilization (bromage 0) and analgesia times. Our secondary aims are to evaluate the first 4, 8, 12, 24 hours VAS (visual analog scale) values, first analgesia time, post op 1 hour bromage scores, postoperative nausea, vomiting, and discharge times, side effects. compare the incidence of effects.
- Conditions
- Post-operative Analgesia, Early Mobility
- Being tested
- combination femoral nerve and popliteal sciatica block, combination adductor canal and IPACK block
- Keywords
- femoral block, knee surgery, sciatic nerve block, IPACK block, Adductor Canal Block, post-operative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination femoral nerve and popliteal sciatica blockCombination product
Also called group FS
Combination of femoral nerve and popliteal sciatica block performed after knee surgery
combination adductor canal and IPACK blockCombination product
Also called group AI
Combination of adductor canal and IPACK block performed after knee surgery
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block add ipack | Patients who received ipack add femoral canal block for postoperative analgesia Receives: Combination Product: combination adductor canal and IPACK block | |
| femoral block add popliteal sciatic | Patients who underwent popliteal sciatic block add femoral block for postoperative analgesia Receives: Combination Product: combination femoral nerve and popliteal sciatica block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative first mobilization time
After receiving spinal anesthesia, patients undergoing elective knee surgery were taken to the operating room. Postoperatively, patients were randomly assigned into two groups using a closed-envelope method. In the first group, patients in the supine position received an adductor canal block with 20 ml of 0.025% bupivacaine and an IPACK block with an additional 20 ml of 0.025% bupivacaine. In the second group, patients in the supine position received a femoral nerve block with 20 ml of 0.025% bupivacaine and a sciatic nerve block administered via the popliteal region with an additional 20 ml of 0.025% bupivacaine. Motor block, analgesia, and mobilization times were assessed at the 2nd, 4th, 8th, and 24th hours postoperatively.In the postoperative period, patients' motor functions were assessed at specific intervals (e.g., at the 2nd, 4th, 8th, 12th and 24th hours) using the Bromage Scale. During each assessment, patients were asked to move their hip, knee, and ankle joints.
Measured: 24 hour
Secondary outcomes (1)
Numerical Rating Scale (NRS) Scores
NRS scores were evaluated at the 2nd, 4th, 8th, 12th, and 24th hours. The Numerical Rating Scale (NRS) is a pain assessment tool where patients rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 representing the worst pain imaginable.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 May 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
- Investigators
- osman çelik, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683313
- Sponsor's protocol ID
- knee surgeries blocks
- Acronym
- kneesurgery
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be shared upon request from the corresponding author via email if desired.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Combination of Popliteal Sciatic and Femoral Block With the Combination of Ipack Adductor Canal Block Duration in Elective Knee Surgeries
- ClinicalTrials.gov ID
- NCT06683313
- Acronym / sponsor ID
- kneesurgery / knee surgeries blocks
- Conditions
- Post-operative Analgesia, Early Mobility
- Keywords
- femoral block, knee surgery, sciatic nerve block, IPACK block, Adductor Canal Block, post-operative analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 12 Nov 2024 (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.
Comparison of the combination of popliteal sciatic and femoral block with the combination of ipack adductor canal blocks and mobilization and analgesia duration in elective knee surgeries
Detailed description
There is concern that about half of patients with elective knee surgery report severe knee pain immediately after surgery. Optimal postoperative knee analgesia is important not only for patient comfort and satisfaction, but also to accelerate mobilization, functional recovery, and hospital discharge. To facilitate earlier ambulation and provide superior pain control, while striving for shorter hospital stays and same-day discharge for patients There is an increasing emphasis on multimodal analgesia and motor sparing regional anesthesia blocks.
To compare the postoperative analgesic efficacy of ipack adductor canal and femoral popliteal sciatic blocks in elective knee surgeries, and the first mobilization (bromage 0) times of motor block after spinal anesthesia. Our primary aim is to compare the ipack adductor canal block added after spinal anesthesia in elective knee surgeries with the combination of femoral + popliteal sciatic block. post of blocks To evaluate the operative mobilization (bromage 0) and analgesia times. Our secondary aims are to evaluate the first 4, 8, 12, 24 hours VAS (visual analog scale) values, first analgesia time, post op 1 hour bromage scores, postoperative nausea, vomiting, and discharge times, side effects. compare the incidence of effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block add ipack | – | Combination Product: combination adductor canal and IPACK blockPatients who received ipack add femoral canal block for postoperative analgesia |
| femoral block add popliteal sciatic | – | Combination Product: combination femoral nerve and popliteal sciatica blockPatients who underwent popliteal sciatic block add femoral block for postoperative analgesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 75 who will undergo knee surgery
Key inclusion criteria (2 listed)
- -
- Exclusion Criteria:Patients who did not consent to the procedure, those with coagulopathy, a known allergy to local anesthetics, a BMI > 35 kg/m², chronic analgesic and opioid use, mental or psychiatric disorders, or inability -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| combination femoral nerve and popliteal sciatica blockAlso: group FSCombination of femoral nerve and popliteal sciatica block performed after knee surgery | Combination product | femoral block add popliteal sciatic |
| combination adductor canal and IPACK blockAlso: group AICombination of adductor canal and IPACK block performed after knee surgery | Combination product | adductor canal block add ipack |
Primary outcome
postoperative first mobilization time
Time frame: 24 hour
After receiving spinal anesthesia, patients undergoing elective knee surgery were taken to the operating room. Postoperatively, patients were randomly assigned into two groups using a closed-envelope method. In the first group, patients in the supine position received an adductor canal block with 20 ml of 0.025% bupivacaine and an IPACK block with an additional 20 ml of 0.025% bupivacaine. In the second group, patients in the supine position received a femoral nerve block with 20 ml of 0.025% bupivacaine and a sciatic nerve block administered via the popliteal region with an additional 20 ml of 0.025% bupivacaine. Motor block, analgesia, and mobilization times were assessed at the 2nd, 4th, 8th, and 24th hours postoperatively.In the postoperative period, patients' motor functions were assessed at specific intervals (e.g., at the 2nd, 4th, 8th, 12th and 24th hours) using the Bromage Scale. During each assessment, patients were asked to move their hip, knee, and ankle joints.
1 secondary outcome
Numerical Rating Scale (NRS) Scores
Time frame: 24 hour
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes. It will be shared upon request from the corresponding author via email if desired.
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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.
osman çelik principal investigator
Gaziosmanpasa Research and Education Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Analgesia and Early Mobility, run by Gaziosmanpasa Research and Education Hospital at 2 sites 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 0 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 first mobilization time (time frame: 24 hour). 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 12 Nov 2024.