A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
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|ClinicalTrials.gov Identifier: NCT02623361|
Recruitment Status : Completed
First Posted : December 7, 2015
Results First Posted : July 5, 2018
Last Update Posted : December 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness | Patient Pain||Drug: Peripheral Nerve Block Drug: Sham Block||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||September 2017|
|Placebo Comparator: Sham||
Drug: Sham Block
Sham Block by saline injection
|Active Comparator: Fascia Iliaca Compartment Block||
Drug: Peripheral Nerve Block
Regional Anesthesia by Local Anesthetic Injection
- Numeric Pain Score [ Time Frame: 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)
- Leg Strength at Discharge From Ambulatory Center, Surgical Leg [ Time Frame: 2 hours after surgery ]measurement of quadriceps strength (Force) using a dynamometer
- Patient Satisfaction [ Time Frame: 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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623361
|United States, California|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Matthias Behrends, MD||University of California|