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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98104
Francis Salinas, MD, 206-223-6980, Francis.Salinas@virginiamason.org
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:
- 3-4 hours after arriving home
- Within 1 hour prior to going to sleep
- Within 1 hour after waking up the following day.
- 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 group | Role | What they receive |
|---|---|---|
| Obturator nerve block | Active comparator | Ultrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5% Receives: Procedure: Obturator Nerve Block; Drug: Ropivacaine |
| Sham block | Placebo comparator | Placebo 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.
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)
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.
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
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.
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).
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.
- First posted27 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis V. Salinas , MD, Benaroya Research Institute
- Investigators
- Francis Salinas, MD, Principal investigator, Virginia Mason Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02346357
- Acronym / sponsor ID
- IRB14003
- Conditions
- Pain
- Keywords
- hip arthroscopy, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- 3-4 hours after arriving home
- Within 1 hour prior to going to sleep
- Within 1 hour after waking up the following day.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obturator nerve block | Active comparator | Procedure: Obturator Nerve Block, Drug: RopivacaineUltrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5% |
| Sham block | Placebo comparator | Procedure: Obturator Nerve Block, Drug: Placebo SalinePlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary unilateral ambulatory hip arthroscopy
- Age 18 to 65 years
- ASA physical status I to III
- Ability to follow the protocol.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obturator Nerve BlockAlso: Nerve blockUltrasound-guided obturator nerve block with 20 mL of treatment drug (Ropivacaine 0.5% [local anesthetic]) 30 minutes prior to induction of anesthesia. | Procedure or surgery | Obturator nerve block, Sham block |
| Ropivacaine | Drug | Obturator nerve block |
| Placebo Saline | Drug | Sham block |
Primary outcome
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
Initial NRS pain score upon arrival in the post anesthesia cafe unit (PACU)
5 secondary outcomes
Post anesthesia care unit discharge (Time required to meet discharge criteria from phase 2 PACU)
Time frame: Wihtin 6 hours from end of surgery.
Nausea (Number of episodes of nausea and vomiting during the 1st 24 hours postoperatively)
Time frame: 1st 24 hours after surgery
Sleep quality on on the day of surgery (Did subjects have difficulty going to sleep or wake up from sleep due to pain?)
Time frame: Within 12-24 hours after discharge to home (from the hospital); typically the same night of the day of surgery.
Opioid (analgesic) consumption
Time frame: From the start of surgery to 24 hours after surgery complete (average surgical duration 2.5 hours).
Pain scores for the 1st 24 hours after surgery (Numeric Rating Scale Pain)
Time frame: 1st 24 hours after completion of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Salinas, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
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.