Post Operative PainPhase 4NCT05609565
Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy
A Phase 4 study testing spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine and spinal anesthesia with bupivacaine in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine and spinal anesthesia with bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 30 Sep 2024
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score I-II.
- Body mass index < 35 kg/m2
Who cannot join
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Known allergy to study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial
- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.
- Conditions
- Post Operative Pain
- Being tested
- spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine, spinal anesthesia with bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaineDrug
spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
spinal anesthesia with bupivacaineDrug
spinal anesthesia with bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine |
| Group 2 | Active comparator | Not described Receives: Drug: spinal anesthesia with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of motor block (minutes)
The duration of motor block (minutes)
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 posted8 Nov 2022
- Study start15 Nov 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609565
- Sponsor's protocol ID
- FMASU MS 706/ 2022
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2022
- Last updated
- 26 Nov 2024
- Results posted
- 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05609565
- Acronym / sponsor ID
- FMASU MS 706/ 2022
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Nov 2022 (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.
- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine |
| Group 2 | Active comparator | Drug: spinal anesthesia with bupivacaine |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) score I-II.
- Body mass index < 35 kg/m2
Key exclusion criteria (4 listed)
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Known allergy to study drugs.
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 |
|---|---|---|
| spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacainespinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine | Drug | Group 1 |
| spinal anesthesia with bupivacainespinal anesthesia with bupivacaine | Drug | Group 2 |
Primary outcome
The duration of motor block (minutes)
Time frame: 24 hours postoperatively
The duration of motor block (minutes)
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 26 Nov 2024.
- 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.
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 spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine and spinal anesthesia with bupivacaine in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
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 4 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 26 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 1 site in Egypt. 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?
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?
The duration of motor block (minutes) (time frame: 24 hours postoperatively). 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 26 Nov 2024.