Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Anesthesia | Experimental | Patients receive spinal anesthesia during MUA (manipulation under anesthesia). |
|
| General Anesthesia | Active Comparator | Patients receive general anesthesia during MUA (manipulation under anesthesia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia | Procedure | Administration of spinal anesthesia for knee manipulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in degrees of motion of the affected knee | At time of procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | Participants will be asked to rate pain on a scale of 0-10 with 0 being no pain and 10 being the worst possible pain. | Baseline, 24 hours, 48 hours, 72 hours post-procedure |
| Opioid use in PACU |
Not provided
Inclusion:
Exclusion:
ASA 4 or 5
Daily chronic opioid use (over 3 months of continuous opioid use).
Inability to communicate pain scores or need for analgesia.
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women (as determined by point-of-care serum bHCG)
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
BMI >50 kg/m2.
Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen
(NSAIDs and acetaminophen)
Contraindication to spinal injection
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Hall | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Recruiting | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| D015742 | Propofol |
| C004616 | chloroprocaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D010636 | Phenols |
Not provided
Not provided
Not provided
Not provided
Not provided
Investigator and surgeon will be masked
| General Anesthesia | Procedure | Administration of general anesthesia for knee manipulation. |
|
| Propofol | Drug | Patients undergoing general anesthesia will receive an induction dose of propofol that will be titrated to effect, and airway support as needed until the patient is appropriately anesthetized for the procedure as determined by the anesthesia and surgical care teams. |
|
| Chloroprocaine | Drug | Patients undergoing spinal anesthesia will receive a spinal injection under standard aseptic technique, with 45mg chloroprocaine. |
|
| Day 3 |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |