Knee ArthroscopyNCT03173326
Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
A study testing General anesthesia and Subarachnoid block in people with Knee Arthroscopy and General Anesthesia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Knee Arthroscopy, General Anesthesia, Subarachnoid Block
- What is being tested?
- General anesthesia and Subarachnoid block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 20 Apr 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA physical status classification of I, II, or III
- Patients without a current diagnosis of chronic pain or chronic opioid use for > 1-month prior to knee arthroscopy
- Patients who are scheduled to undergo unilateral knee arthroscopy
- Patients do not have a contraindication to receiving regional anesthesia
Who cannot join
- Preexisting sensory or motor deficit in operative extremity
- Patients with a contraindication to general anesthesia
- Patient undergoing meniscal or ligamentous repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.
Read the detailed description
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl. The study evaluates pain scores, opioid utilization and patient satisfaction.
- Conditions
- Knee Arthroscopy, General Anesthesia, Subarachnoid Block
- Being tested
- General anesthesia, Subarachnoid block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
General anesthesia will be delivered per standard procedure. General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC).
Subarachnoid blockProcedure or surgery
Neuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position. After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient's height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine.
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid block | Experimental | Not described Receives: Procedure: Subarachnoid block |
| General anesthesia | Active comparator | Not described Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: Discharge from post anesthesia care unit (PACU) (usually one hour)
Pain score
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: Post operative day one
Pain score
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: One month postoperatively
Pain score
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: Three months postoperatively
Opioid utilization
Opioid utilization based on amount of opioid medications administered
Measured: Surgical completion to PACU discharge (usually one hour)
Opioid utilization
Opioid utilization based on number of pain pills taken
Measured: Postoperative day one
Opioid utilization
Opioid utilization based on average number of pain pills taken per day
Measured: One month postoperatively
Opioid utilization
Opioid utilization based on average number of pain pills taken per day
Measured: Three months postoperatively
Secondary outcomes (1)
Patient satisfaction with anesthetic
Patient satisfaction with anesthetic based on 10-item patient satisfaction survey validated for regional and general anesthesia
Measured: 24 hours after PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start16 Jun 2017
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Why it stopped: Staffing changes at site. No longer feasible at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Walters, Vanderbilt University Medical Center
- Investigators
- Jenna Walters, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173326
- Sponsor's protocol ID
- 170741
- Status last verified
- Aug 2018
- First submitted
- 29 May 2017
- Last updated
- 8 Aug 2018
- 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 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT03173326
- Acronym / sponsor ID
- 170741
- Conditions
- Knee Arthroscopy, General Anesthesia, Subarachnoid Block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing changes at site. No longer feasible at site.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 1 Jun 2017 (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.
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.
Detailed description
The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl. The study evaluates pain scores, opioid utilization and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid block | Experimental | Procedure: Subarachnoid block |
| General anesthesia | Active comparator | Procedure: General anesthesia |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ASA physical status classification of I, II, or III
- Patients without a current diagnosis of chronic pain or chronic opioid use for > 1-month prior to knee arthroscopy
- Patients who are scheduled to undergo unilateral knee arthroscopy
- Patients do not have a contraindication to receiving regional anesthesia
Key exclusion criteria (3 listed)
- Preexisting sensory or motor deficit in operative extremity
- Patients with a contraindication to general anesthesia
- Patient undergoing meniscal or ligamentous repair
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 |
|---|---|---|
| General anesthesiaGeneral anesthesia will be delivered per standard procedure. General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC). | Procedure or surgery | General anesthesia |
| Subarachnoid blockNeuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position. After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient's height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine. | Procedure or surgery | Subarachnoid block |
Primary outcome
Pain score
Time frame: Discharge from post anesthesia care unit (PACU) (usually one hour)
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Pain score
Time frame: Post operative day one
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Pain score
Time frame: One month postoperatively
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Pain score
Time frame: Three months postoperatively
Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.
Opioid utilization
Time frame: Surgical completion to PACU discharge (usually one hour)
Opioid utilization based on amount of opioid medications administered
Opioid utilization
Time frame: Postoperative day one
Opioid utilization based on number of pain pills taken
Opioid utilization
Time frame: One month postoperatively
Opioid utilization based on average number of pain pills taken per day
Opioid utilization
Time frame: Three months postoperatively
Opioid utilization based on average number of pain pills taken per day
1 secondary outcome
Patient satisfaction with anesthetic
Time frame: 24 hours after PACU discharge
Results and safety
The study was stopped early (reason given: Staffing changes at site. No longer feasible at site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Knee Arthroscopy
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
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.
Jenna Walters, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Subarachnoid block in people with Knee Arthroscopy and General Anesthesia, run by Vanderbilt University Medical Center at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Aug 2018. 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 United States. 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 was stopped early (reason given: Staffing changes at site. No longer feasible at site.). 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?
Pain score (time frame: Discharge from post anesthesia care unit (PACU) (usually one hour)). The study lists 8 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 8 Aug 2018.