Postoperative Pain After Knee ArthroscopyNCT03530280
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
A study testing pregabalin (lyrica) and adductor canal block including bupivacaine in people with Postoperative Pain After Knee Arthroscopy, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain After Knee Arthroscopy
- What is being tested?
- pregabalin (lyrica) and adductor canal block including bupivacaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Dec 2018
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 70 years
- American Society of Anesthesiologists I or II
- Scheduled to undergo knee arthroscopy
Who cannot join
- allergic to any medicines
- History of drug or alcohol abuse,
- Opioids or sedative medications
- History of psychiatric conditions
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Teaching and Research Hospital
Ankara, Altindag
About this study
Official title: Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.
Read the detailed description
Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.
- Being tested
- pregabalin (lyrica), Placebo oral tablet, adductor canal block including bupivacaine
- Keywords
- pregabalin, adductor canal block, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin (lyrica)Drug
preoperative pregabalin and the postoperative sham block will perform.
Placebo oral tabletDrug
The preoperative placebo oral tablet and the postoperative sham block will perform.
adductor canal block including bupivacaineDrug
The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
| Study group | Role | What they receive |
|---|---|---|
| pregabalin (lyrica) | Active comparator | pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform. Receives: Drug: pregabalin (lyrica) |
| placebo group | Placebo comparator | a placebo capsule 1 hour before surgery and the postoperative sham block will perform. Receives: Drug: Placebo oral tablet |
| adductor channel block group | Active comparator | A preoperative placebo capsule will be given.This group will receive postoperative adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine Receives: Drug: adductor canal block including bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point numerical rating scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Measured: 24 hours
tramadol consumption
24 hours tramadol consumption will be recorded as milligrams
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jun 2018
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Knee ArthroscopyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530280
- Sponsor's protocol ID
- pregabalin
- Status last verified
- Oct 2019
- First submitted
- 26 Mar 2018
- Last updated
- 18 Oct 2019
- 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 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
- ClinicalTrials.gov ID
- NCT03530280
- Acronym / sponsor ID
- pregabalin
- Keywords
- pregabalin, adductor canal block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 21 May 2018 (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.
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.
Detailed description
Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pregabalin (lyrica) | Active comparator | Drug: pregabalin (lyrica)pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform. |
| placebo group | Placebo comparator | Drug: Placebo oral tableta placebo capsule 1 hour before surgery and the postoperative sham block will perform. |
| adductor channel block group | Active comparator | Drug: adductor canal block including bupivacaineA preoperative placebo capsule will be given.This group will receive postoperative adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 and 70 years
- American Society of Anesthesiologists I or II
- Scheduled to undergo knee arthroscopy
Key exclusion criteria (5 listed)
- allergic to any medicines
- History of drug or alcohol abuse,
- Opioids or sedative medications
- History of psychiatric conditions
- Pregnant or lactating women
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 |
|---|---|---|
| pregabalin (lyrica)preoperative pregabalin and the postoperative sham block will perform. | Drug | pregabalin (lyrica) |
| Placebo oral tabletThe preoperative placebo oral tablet and the postoperative sham block will perform. | Drug | placebo group |
| adductor canal block including bupivacaineThe preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine | Drug | adductor channel block group |
Primary outcome
11-point numerical rating scale (NRS)
Time frame: 24 hours
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
tramadol consumption
Time frame: 24 hours
24 hours tramadol consumption will be recorded as milligrams
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 18 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain After Knee Arthroscopy
Not yet recruitingPhase 4
Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
Post Operative Swelling
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Recruiting
Acupuncture for Pain Control After Ambulatory Knee Arthroscopy
Postoperative Pain; Knee Arthroscopy; Acupuncture
Not yet recruitingPhase 4
Effects of Intraarticular Tramadol and Tramadol-Dexamethasone on Postoperative Pain After Knee Arthroscopy
Knee Arthroscopy, Postoperative Pain
Not yet recruiting
Effects of Music Listening and Relaxation Interventions on Postoperative Recovery After Knee Surgery
Knee Surgery, Kinesiophobia (Fear of Movement)
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 study testing pregabalin (lyrica) and adductor canal block including bupivacaine in people with Postoperative Pain After Knee Arthroscopy, run by Ankara Diskapi 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 3 inclusion and 5 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 18 Oct 2019. 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. 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.
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?
11-point numerical rating scale (NRS) (time frame: 24 hours). The study lists 2 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 18 Oct 2019.