A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

Pain Clinical Trial

Official title:

A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623361
• Other study ID #: FICB for hip athroscopy
• Status: Completed
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Muscle Weakness | Patient
• Pain
• Paresis

Intervention

Drug:
• Peripheral Nerve Block
Regional Anesthesia by Local Anesthetic Injection
• Sham Block
Sham Block by saline injection

Locations

Country	Name	City	State
United States	Orthopedic Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	within one hour after surgery
Secondary	Leg Strength at Discharge From Ambulatory Center, Surgical Leg	measurement of quadriceps strength (Force) using a dynamometer	2 hours after surgery
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"	48 hours