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PainNCT02346357

Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy

A study testing Obturator Nerve Block and Ropivacaine in people with Pain, run by Benaroya Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The purpose of this study is to investigate the analgesic efficacy of preoperative obturator nerve block as measured by postoperative pain scores and postoperative analgesic requirements. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain
What is being tested?
Obturator Nerve Block and Ropivacaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteUnited States
Study dates
May 2014to Sep 2015
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary unilateral ambulatory hip arthroscopy
  • Age 18 to 65 years
  • ASA physical status I to III
  • Ability to follow the protocol.

Who cannot join

  • Age <18 or >65 years of age
  • Contraindications to peripheral nerve blockade
  • Allergy to opioids or local anesthetics
  • Allergy to sulfa medications or nonsteroidal anti-inflammatory medications
  • Chronic opioid
  • Patient refusal

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Virginia Mason Medical Center

    Seattle, Washington, 98104

    Francis Salinas, MD, 206-223-6980, Francis.Salinas@virginiamason.org

    Recruiting

Other trials in United States

About this study

Official title: Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy: A Prospective, Randomized Controlled Trial

Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The purpose of this study is to investigate the analgesic efficacy of preoperative obturator nerve block as measured by postoperative pain scores and postoperative analgesic requirements. The primary outcome will be the patient's first reported pain scores in the post anesthesia care unit (PACU).

Read the detailed description

RESEARCH DESIGN AND METHODS Patient selection The proposed study will be a prospective randomized placebo-controlled trial. Eligibility criteria will include patients having primary unilateral ambulatory hip arthroscopy for femoral acetabular impingement, age 18 to 65 years, ASA physical status I to III, and ability to follow the protocol.

Exclusion criteria: patient refusal, inability to comprehend the consent form, age < 18, and > 65 years of age; contraindications to obturator nerve blockade (pre-existing neuromuscular or peripheral nerve disorder, localized infection, or bleeding disorder); allergy to opioids or local anesthetics; allergy to celecoxib or sulfa medications or nonsteroidal anti-inflammatory medications (NSAIDs); chronic opioid use (> 1 month of 60 mg morphine PO equivalents daily); and, women who are pregnant or breastfeeding.

Consent Patients will be enrolled preoperatively in either the orthopedic surgery clinic or through the anesthesia preoperative clinic after the hip arthroscopy surgery is scheduled

Randomization, Blinding, and Allocation

Study medications will be administered by the primary investigator who will perform or closely supervise all ultrasound-guided obturator nerve blocks. Randomization will be performed with use of computerized random number generator and then each assignment will be placed into an opaque sealed envelope. Upon enrollment into the study and consent obtained, the next sealed envelope (numbered sequentially) will be opened and the patient allocated to either:

  • Group 1 (Treatment), Ultrasound-guided obturator nerve block: 20 ml ropivacaine 0.5%
  • Group 2 (Placebo), Ultrasound-guided saline placebo block: 5 mL sterile saline 0.9% The primary investigator will not be involved in any subsequent postoperative data collection. The sub-investigators will perform all subsequent data collection and will be blinded to group allocation.

Intervention Following randomization, the principle investigator will perform the block procedure 30 minutes prior to expected transfer back to the operating room.

Anesthetic care All intraoperative anesthetic care will be standardized as well, including general endotracheal anesthesia induction using propofol 1.5-2mg/kg IV, succinylcholine 1-1.5mg/kg IV or rocuronium 0.6-1mg/kg IV (based on the clinical discretion of the blinded anesthesia provider). In order to provide adequate intraoperative analgesia for both groups for the expected duration of the procedure, 1 mg of intravenous hydromorphone will be administered 10 minutes prior to surgical incision.

No further intraoperative opioids will be administered. Neuromuscular blockade will be maintained with rocuronium as indicated by surgical requirements and titrated by neuromuscular monitoring, and reversed in standard fashion prior to emergence from general anesthesia. At the end of the procedure, the surgeon will inject ropivacaine 0.25% 30 mL in each of the 2 arthroscopic portal sites for a total of 60 ml ropivacaine 0.25% in all subjects as is standard practice for all hip arthroscopy patients.

Subjects will be given a log to record their postoperative pain scores and oxycodone consumption for the 1st 24 hours after discharge.

Outcomes The primary outcome will be the pain immediately upon arrival to the post anesthesia care unit. This will be measured by an 11-point numerical rating scale (NRS 0 = no pain, and 10 = worst pain imaginable).

Secondary outcomes will include NRS pain scores at additional time frames for pain score self-assessments will include:

  1. 3-4 hours after arriving home
  2. Within 1 hour prior to going to sleep
  3. Within 1 hour after waking up the following day.
  4. 24 hours after surgery

Additional secondary outcomes will also include: cumulative 24-hour postoperative opioid consumption, percentage of patients with postoperative nausea and vomiting, sleep disturbance (difficulty going to sleep or waking up from sleep due to postoperative pain).

Expected Time Frame

Typically, 4-5 hip arthroscopies per week are performed. Thus the expected timetable for recruitment will take at least 6-12 months

Conditions
Pain
Being tested
Obturator Nerve Block, Ropivacaine, Placebo Saline
Keywords
hip arthroscopy, analgesia
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obturator Nerve BlockProcedure or surgery

    Also called Nerve block

    Ultrasound-guided obturator nerve block with 20 mL of treatment drug (Ropivacaine 0.5% [local anesthetic]) 30 minutes prior to induction of anesthesia.

  • RopivacaineDrug

  • Placebo SalineDrug

Study groups in NCT02346357
Study groupRoleWhat they receive
Obturator nerve blockActive comparatorUltrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5%
Receives: Procedure: Obturator Nerve Block; Drug: Ropivacaine
Sham blockPlacebo comparatorPlacebo arm. Ultrasound-guided injection of 3-5 mL normal saline in the subcutaneous tissue in the same location as would for an obturator nerve block.
Receives: Procedure: Obturator Nerve Block; Drug: Placebo Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate pain score upon arrival to phase 1 PACU (NRS pain score)

    Initial NRS pain score upon arrival in the post anesthesia cafe unit (PACU)

    Measured: Within 5-30 minutes upon leaving operating room and arrival to Phase I recovery

Secondary outcomes (5)
  1. Post anesthesia care unit discharge (Time required to meet discharge criteria from phase 2 PACU)

    Time required to meet discharge criteria from phase 2 PACU, able to be discharged home

    Measured: Wihtin 6 hours from end of surgery.

  2. Nausea (Number of episodes of nausea and vomiting during the 1st 24 hours postoperatively)

    Number of episodes of nausea and vomiting during the 1st 24 hours postoperatively

    Measured: 1st 24 hours after surgery

  3. Sleep quality on on the day of surgery (Did subjects have difficulty going to sleep or wake up from sleep due to pain?)

    Did subjects have difficulty going to sleep or wake up from sleep due to pain?

    Measured: Within 12-24 hours after discharge to home (from the hospital); typically the same night of the day of surgery.

  4. Opioid (analgesic) consumption

    Cumulative 24-hr postoperative opioid consumption

    Measured: From the start of surgery to 24 hours after surgery complete (average surgical duration 2.5 hours).

  5. Pain scores for the 1st 24 hours after surgery (Numeric Rating Scale Pain)

    Numeric Rating Scale Pain prior to hospital discharge, 1 hour after arriving home, 4 hours after arriving home, 1 hour prior to going to sleep, 1 hour after waking up the next morning, 24 hours after surgery

    Measured: 1st 24 hours after completion of surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015 (estimated)
  4. Study completionSep 2015 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346357
Sponsor's protocol ID
IRB14003
Status last verified
Jan 2015
First submitted
20 Nov 2014
Last updated
27 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Obturator Nerve Block and Ropivacaine in people with Pain, run by Benaroya Research Institute 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 6 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francis Salinas, MD (206-223-6980, Francis.Salinas@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate pain score upon arrival to phase 1 PACU (NRS pain score) (time frame: Within 5-30 minutes upon leaving operating room and arrival to Phase I recovery). 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 27 Jan 2015.

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