Risk Factors for Post ACL Reconstruction PainNCT05533489
Risk Factors for Post ACL Reconstruction Pain
An observational study of Risk Factors for Post ACL Reconstruction Pain, run by Prince of Songkla University.
Trial summary
In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Factors for Post ACL Reconstruction Pain
- How many people
- 924 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament)
Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament) Age ≥ 15 years
About this study
Official title: Risk Factors for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction
In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. Over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.
Read the detailed description
At present, multimodal analgesia is a successful mainstay treatment for arthroscopic anterior cruciate ligament surgery which range from opioid, paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), local anesthetic agents, ketamine, corticosteroid, and cold compression therapy. Previous study showed femoral nerve block reduces pain score but also increases incidence of falling. Afterward, a study on adductor canal block showed equivalent postoperative analgesia while preserving quadriceps strength. Furthermore, a few studies were conducted to determine risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery, but results are contradictory. Previous research found risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery are female, young age, smoker, preoperative visual analog scale score ≥3, tourniquet time > 50 minutes, and cartilage injury. In addition, evidence showed higher preoperative visual analog scale, and previous opioid use are associated with greater amount of opioid consumption. In contrary, some evidence showed no effect of age, sex, body mass index (BMI), tourniquet time, type of anesthesia on post postoperative pain after arthroscopic anterior cruciate ligament surgery.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention This study is a retrospective descriptive study.
What is being measured
The primary outcome is the main question the study is designed to answer.
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours.
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Measured: Three days
Secondary outcomes (2)
To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Measured: Three days
To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year
To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year
Measured: One year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for Post ACL Reconstruction PainStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 924 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533489
- Sponsor's protocol ID
- REC.65-319-8-1
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05533489
- Acronym / sponsor ID
- REC.65-319-8-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Sep 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.
In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. Over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.
Detailed description
At present, multimodal analgesia is a successful mainstay treatment for arthroscopic anterior cruciate ligament surgery which range from opioid, paracetamol, non-steroidal anti-inflammatory agents (NSAIDs), local anesthetic agents, ketamine, corticosteroid, and cold compression therapy. Previous study showed femoral nerve block reduces pain score but also increases incidence of falling. Afterward, a study on adductor canal block showed equivalent postoperative analgesia while preserving quadriceps strength. Furthermore, a few studies were conducted to determine risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery, but results are contradictory. Previous research found risk factors for postoperative pain after arthroscopic anterior cruciate ligament surgery are female, young age, smoker, preoperative visual analog scale score ≥3, tourniquet time > 50 minutes, and cartilage injury. In addition, evidence showed higher preoperative visual analog scale, and previous opioid use are associated with greater amount of opioid consumption. In contrary, some evidence showed no effect of age, sex, body mass index (BMI), tourniquet time, type of anesthesia on post postoperative pain after arthroscopic anterior cruciate ligament surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament)
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 |
|---|---|---|
| No interventionNo intervention This study is a retrospective descriptive study. | Other | – |
Primary outcome
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours.
Time frame: Three days
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
2 secondary outcomes
To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours
Time frame: Three days
To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year
Time frame: One year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Risk Factors for Post ACL Reconstruction Pain, run by Prince of Songkla University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Sep 2022. 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?
Results are not available in the source record.
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?
To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours. (time frame: Three days). 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 9 Sep 2022.