Muscle Weakness | Patient, Pain
Conditions
Brief summary
Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia. This is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy. The enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.
Detailed description
Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery. Patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area. Pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.
Interventions
DRUGPeripheral Nerve Block
Regional Anesthesia by Local Anesthetic Injection
DRUGSham Block
Sham Block by saline injection
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age at least 18 years old * American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery
Exclusion criteria
* Age younger than 18 years old * Non-English speaking * Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic) * Preexisting neurologic deficits of operative limb * Need for postoperative nerve function test * Inability to consent due to cognitive dysfunction * Chronic pain * Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score | within one hour after surgery | highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leg Strength at Discharge From Ambulatory Center, Surgical Leg | 2 hours after surgery | measurement of quadriceps strength (Force) using a dynamometer |
| Patient Satisfaction | 48 hours | patient questionaire, patients are contacted 48 h after surgery patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating not satisfied at all and 10 indicating very satisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Sham Block: Sham Block by saline injection | 40 |
| FICB Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection | 38 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | FICB | Total | Sham |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 11 | 34 years STANDARD_DEVIATION 10 | 32 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 38 participants | 78 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 38 Participants | 23 Participants |
| Sex: Female, Male Male | 23 Participants | 40 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
Primary
Numeric Pain Score
highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)
Time frame: within one hour after surgery
Population: Exclusion criteria for enrollment included age younger than 18 years, contraindications for regional anesthesia, pre-existing neurologic deficits of the lower extremity, and a history of chronic pain requiring chronic opioid medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Numeric Pain Score | 7 units on the numeric rating scale (0-10) | Standard Deviation 2 |
| FICB | Numeric Pain Score | 6 units on the numeric rating scale (0-10) | Standard Deviation 2 |
Secondary
Leg Strength at Discharge From Ambulatory Center, Surgical Leg
measurement of quadriceps strength (Force) using a dynamometer
Time frame: 2 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Leg Strength at Discharge From Ambulatory Center, Surgical Leg | 139 Newton | Standard Deviation 99 |
| FICB | Leg Strength at Discharge From Ambulatory Center, Surgical Leg | 41 Newton | Standard Deviation 61 |
Secondary
Patient Satisfaction
patient questionaire, patients are contacted 48 h after surgery patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating not satisfied at all and 10 indicating very satisfied
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham | Patient Satisfaction | 10 units on the numeric rating scale (0-10) | Standard Deviation 0 |
| FICB | Patient Satisfaction | 10 units on the numeric rating scale (0-10) | Standard Deviation 1 |