SurgeryNCT03557125
Quadratus Lumborum Block for Analgesia Following Hip Arthroscopy
A study testing QL Block and Saline Skin Wheel in people with Surgery, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Evaluate difference in postoperative opiate consumption when patients do or do not receive a quadratus lumborum block preoperatively for hip arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- QL Block and Saline Skin Wheel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 14 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years-old
- Undergoing elective hip arthroscopy. Exclusion Criteria
- Local anesthetic allergy
- Chlorhexidine allergy
- Patient weight < 40kg
- Patient is currently pregnant
Show all 10Show fewer
- Patient is unable or chooses not to give informed consent
- Emergency surgery
- Known preoperative substance abuse
- Preoperative opioid use for over three months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Utilization of Quadratus Lumborum Block for Postoperative Analgesia Following Hip Arthroscopy: A Prospective, Randomized Clinical Trial
Evaluate difference in postoperative opiate consumption when patients do or do not receive a quadratus lumborum block preoperatively for hip arthroscopy.
Read the detailed description
The number of hip arthroscopy cases has surged with over a 200% increased experienced between 2007 and 2011]. This increased number of cases is due to both improved techniques and an increased number of indications]. As with most newer operative techniques, the optimal method of perioperative pain control is still emerging and past publications indicate that the majority of patients experience moderate to severe pain postoperative pain. In the wake of a national opioid epidemic, consistent and reliable implementation of non-opioid analgesic strategies is exceedingly important and regional anesthesia often plays a key role in postoperative pain management.
Although quadratus lumborum blocks were first described in 2007 as an truncal block, numerous publications have recently highlighted its effectiveness as an analgesic technique for hip fracture and hip arthroplasty and possibly the ideal regional technique for hip arthroscopy. Unfortunately, prospective randomized studies are lacking. This prospective study would randomize patient to receive or not receive a quadratus plane block prior to surgery. The primary end point would be opioid consumption in the postoperative anesthesia care unit. Our hypothesis is that quadratus lumborum blocks will decrease postoperative opioid consumption.
The quadratus lumborum blocks is fascial plane block. Originally described for abdominal surgery, numerous case reports and editorial publications have highlighted the effectiveness of quadratus lumborum blocks as an analgesic technique for hip fracture and hip arthroplasty and possibly the ideal regional technique for hip arthroscopy. Unfortunately, prospective randomized studies are lacking.
The quadratus lumborum block is performed by injecting local anesthetic deep to the transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidiocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.
Risks of the quadratus lumborum block are similar to most truncal blocks and include infection, bleeding, bowel perforation or local anesthethetic toxicity (LAST). Infection risk is minimized by utilizing appropriate antiseptic and sterile technique as is standard for any regional procedure. Risk of a retroperitoneal hematoma is increased with the deep (QL3) approach to the quadratus lumborum block because of its transmuscular approach and likelihood of abdominal branches of lumbar arteries in the path of the needle. For this reason, this (QL3) approach to the quadratus lumborum block will not be used for this study. The risk of LAST is a risk with any regional procedure and is minimized by frequent aspiration, incremental local anesthetic injection and vital signs monitoring throughout.
The quadratus lumborum block is already a block utilized daily at MUSC for a variety of surgical procedures to decrease postoperative pain. Additionally, the block has been offered at MUSC to patients with uncontrolled postoperative pain following hip arthroscopy with excellent resulting analgesia. Unfortunately, whether a patient undergoing hip arthroscopy at MUSC is offered a quadratus lumborum block for postoperative pain is currently highly provider dependent. We hypothesize that preoperative quadratus lumborum blocks will reduce opioid consumption following elective hip arthroscopy.
Sample size was determined using G*Power version 3.1.9.2 software. Using preliminary data, we estimate that we will need 19 subjects in each group (N=38) to have sufficient power (80%) at alpha=0.05 to test the hypothesis of a 30% decrease in IV ME opioid consumption in patients having a QL block vs. those with no block. Accounting for a possible 20% withdrawal, we anticipate the need to enroll 46 total subjects.
Patients will be invited to participate by a study team member that is IRB approved, CITI certified and trained on the protocol. Eligibility will be determined by screening the operating room schedule for patients undergoing hip arthroscopy.
Patients will be enrolled on the day of surgery in the preoperative holding area. After discussion with surgeons, patients will be educated on the role of regional anesthesia in postoperative analgesia and a quadratus lumborum block described.
During pre-operative appointments the surgeons will notify potential participants that they may be invited to participate in this study on the day of surgery. The surgeon will provide potential participants with the consent document to review prior to day of surgery. After discussion in the preoperative holding area regarding risks and benefits of the study and the quadratus lumborum block, patients will be consented if they choose to participate. Consent will be obtained from patient by an IRB approved CITI certified study team member that has been trained on the protocol. Copies of all documents will be provided to the patients. Once patients are consented, they will be assigned a two digit enrollment number. Prior to patient enrollment, randomization will done by a statistician and randomized group (no block (current practice) or quadratus lumborum block) assigned based on the patient enrollment number.
This prospective, single blinded clinical trial will randomize patient to receive or not receive a preoperative quadratus lumborum block prior to elective hip arthroscopy. The consent form will be distributed to patients preoperatively in the surgeon's office. On the day of surgery in the preoperative holding area, patient undergoing elective hip arthroscopy would be informed about the trial and the block with both the risks and benefits. If they are interested in participating, informed consent would then be completed.
Once patients have signed an informed consent, they would be assigned a two-digit identification number. Numbers would be assigned sequentially with the first enrolled patient receiving "01," the second patient receiving "02," and the last patient receiving number "38." Randomization will be created prior to the study starting by a statistician with half of the research subject number being assigned to receive a nerve block and the other half assigned to not receive a block, which is our current standard of care. The regional anesthesia team will open the envelope labeled with the patient's assigned number to reveal the randomization.
Following informed consent, all patients will be positioned, prepped and sedated for a quadratus lumborum block in the preoperative holding area to blind the patient, surgeon, intraoperative anesthesia team and data collectors. The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the patient will receive sedation for their comfort. The relevant anatomy will then be identified using an ultrasound. The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
Care in the perioperative period will otherwise be standardized. As part of routine care, all patients will receive general anesthesia. After receiving 100µg of fentanyl intraoperatively, hydromorphone or morphine will be administered and titrated by the anesthesia care team for postoperative pain control. In the post-anesthesia care unit (PACU), hydromorphone or morphine would continue to be titrated by the PACU nurse for the patient's comfort. The total opioids administered after the initial 100µg of fentanyl would be compared between groups in order to evaluate the effect of the quadratus lumborum block.
Data collection will begin after informed consent is completed. Data collection will include demographic data, operative date/time, medications administered intraoperative and postoperative, time to meet discharge criteria in PACU and visual analog scores (VAS) for pain and satisfaction. VAS scores for pain will be collected prior to surgery, on PACU arrival (when aware enough to do so) and upon meeting PACU discharge criteria. Patient satisfaction will be recorded upon meeting PACU discharge criteria. Effects of the block (numbness or motor weakness) will be recorded. Opioid side effects including nausea, vomiting, and itching will also be noted. Patients will be called on postoperative day one to assess block duration and satisfaction with care.
- Conditions
- Surgery
- Being tested
- QL Block, Saline Skin Wheel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL BlockOther
If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
Saline Skin WheelOther
The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point.
| Study group | Role | What they receive |
|---|---|---|
| Receives QL Block | Active comparator | If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance. Receives: Other: QL Block |
| Receives Saline Skin Wheel No Block | Placebo comparator | The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. Receives: Other: Saline Skin Wheel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
opioid consumption including intraoperative consumption exceeding 100µg of fentanyl and all postoperative opioid consumption in the postoperative anesthesia care unit (PACU).
Measured: 24 hours
Secondary outcomes (6)
Visual Analog Pain
visual analog pain scaled on PACU arrival. The visual analog scale is measured 0-100. Zero being no pain at all and 100 being the worse pain the participant has ever experienced.
Measured: Immediately Post Operatively
Visual Analog Scale at Time of Post Anesthesia Care Unit Discharge
The visual analog scale is measured 0-100. Zero being no pain at all and 100 being the worse pain the participant has ever experienced.
Measured: 2 hours
Post Anesthesia Care Unit Duration
Measured: 2 hours
Patient Satisfaction
The scale is measure 0-10. Zero being not satisfied with pain control at all and 10 being totally satisfied with pain control.
Measured: 24 hours
Opioid Related Side Effects
Measured: 24 hours
Duration of Nerve Block
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start22 May 2018
- Primary completion13 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Model description
- The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia H Wilson, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557125
- Sponsor's protocol ID
- Pro00076191
- Status last verified
- Jan 2021
- First submitted
- 4 Jun 2018
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Quadratus Lumborum Block for Postoperative Analgesia Following Hip Arthroscopy: A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03557125
- Acronym / sponsor ID
- Pro00076191
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate difference in postoperative opiate consumption when patients do or do not receive a quadratus lumborum block preoperatively for hip arthroscopy.
Detailed description
The number of hip arthroscopy cases has surged with over a 200% increased experienced between 2007 and 2011]. This increased number of cases is due to both improved techniques and an increased number of indications]. As with most newer operative techniques, the optimal method of perioperative pain control is still emerging and past publications indicate that the majority of patients experience moderate to severe pain postoperative pain. In the wake of a national opioid epidemic, consistent and reliable implementation of non-opioid analgesic strategies is exceedingly important and regional anesthesia often plays a key role in postoperative pain management.
Although quadratus lumborum blocks were first described in 2007 as an truncal block, numerous publications have recently highlighted its effectiveness as an analgesic technique for hip fracture and hip arthroplasty and possibly the ideal regional technique for hip arthroscopy. Unfortunately, prospective randomized studies are lacking. This prospective study would randomize patient to receive or not receive a quadratus plane block prior to surgery. The primary end point would be opioid consumption in the postoperative anesthesia care unit. Our hypothesis is that quadratus lumborum blocks will decrease postoperative opioid consumption.
The quadratus lumborum blocks is fascial plane block. Originally described for abdominal surgery, numerous case reports and editorial publications have highlighted the effectiveness of quadratus lumborum blocks as an analgesic technique for hip fracture and hip arthroplasty and possibly the ideal regional technique for hip arthroscopy. Unfortunately, prospective randomized studies are lacking.
The quadratus lumborum block is performed by injecting local anesthetic deep to the transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidiocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.
Risks of the quadratus lumborum block are similar to most truncal blocks and include infection, bleeding, bowel perforation or local anesthethetic toxicity (LAST). Infection risk is minimized by utilizing appropriate antiseptic and sterile technique as is standard for any regional procedure. Risk of a retroperitoneal hematoma is increased with the deep (QL3) approach to the quadratus lumborum block because of its transmuscular approach and likelihood of abdominal branches of lumbar arteries in the path of the needle. For this reason, this (QL3) approach to the quadratus lumborum block will not be used for this study. The risk of LAST is a risk with any regional procedure and is minimized by frequent aspiration, incremental local anesthetic injection and vital signs monitoring throughout.
The quadratus lumborum block is already a block utilized daily at MUSC for a variety of surgical procedures to decrease postoperative pain. Additionally, the block has been offered at MUSC to patients with uncontrolled postoperative pain following hip arthroscopy with excellent resulting analgesia. Unfortunately, whether a patient undergoing hip arthroscopy at MUSC is offered a quadratus lumborum block for postoperative pain is currently highly provider dependent. We hypothesize that preoperative quadratus lumborum blocks will reduce opioid consumption following elective hip arthroscopy.
Sample size was determined using G*Power version 3.1.9.2 software. Using preliminary data, we estimate that we will need 19 subjects in each group (N=38) to have sufficient power (80%) at alpha=0.05 to test the hypothesis of a 30% decrease in IV ME opioid consumption in patients having a QL block vs. those with no block. Accounting for a possible 20% withdrawal, we anticipate the need to enroll 46 total subjects.
Patients will be invited to participate by a study team member that is IRB approved, CITI certified and trained on the protocol. Eligibility will be determined by screening the operating room schedule for patients undergoing hip arthroscopy.
Patients will be enrolled on the day of surgery in the preoperative holding area. After discussion with surgeons, patients will be educated on the role of regional anesthesia in postoperative analgesia and a quadratus lumborum block described.
During pre-operative appointments the surgeons will notify potential participants that they may be invited to participate in this study on the day of surgery. The surgeon will provide potential participants with the consent document to review prior to day of surgery. After discussion in the preoperative holding area regarding risks and benefits of the study and the quadratus lumborum block, patients will be consented if they choose to participate. Consent will be obtained from patient by an IRB approved CITI certified study team member that has been trained on the protocol. Copies of all documents will be provided to the patients. Once patients are consented, they will be assigned a two digit enrollment number. Prior to patient enrollment, randomization will done by a statistician and randomized group (no block (current practice) or quadratus lumborum block) assigned based on the patient enrollment number.
This prospective, single blinded clinical trial will randomize patient to receive or not receive a preoperative quadratus lumborum block prior to elective hip arthroscopy. The consent form will be distributed to patients preoperatively in the surgeon's office. On the day of surgery in the preoperative holding area, patient undergoing elective hip arthroscopy would be informed about the trial and the block with both the risks and benefits. If they are interested in participating, informed consent would then be completed.
Once patients have signed an informed consent, they would be assigned a two-digit identification number. Numbers would be assigned sequentially with the first enrolled patient receiving "01," the second patient receiving "02," and the last patient receiving number "38." Randomization will be created prior to the study starting by a statistician with half of the research subject number being assigned to receive a nerve block and the other half assigned to not receive a block, which is our current standard of care. The regional anesthesia team will open the envelope labeled with the patient's assigned number to reveal the randomization.
Following informed consent, all patients will be positioned, prepped and sedated for a quadratus lumborum block in the preoperative holding area to blind the patient, surgeon, intraoperative anesthesia team and data collectors. The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the patient will receive sedation for their comfort. The relevant anatomy will then be identified using an ultrasound. The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
Care in the perioperative period will otherwise be standardized. As part of routine care, all patients will receive general anesthesia. After receiving 100µg of fentanyl intraoperatively, hydromorphone or morphine will be administered and titrated by the anesthesia care team for postoperative pain control. In the post-anesthesia care unit (PACU), hydromorphone or morphine would continue to be titrated by the PACU nurse for the patient's comfort. The total opioids administered after the initial 100µg of fentanyl would be compared between groups in order to evaluate the effect of the quadratus lumborum block.
Data collection will begin after informed consent is completed. Data collection will include demographic data, operative date/time, medications administered intraoperative and postoperative, time to meet discharge criteria in PACU and visual analog scores (VAS) for pain and satisfaction. VAS scores for pain will be collected prior to surgery, on PACU arrival (when aware enough to do so) and upon meeting PACU discharge criteria. Patient satisfaction will be recorded upon meeting PACU discharge criteria. Effects of the block (numbness or motor weakness) will be recorded. Opioid side effects including nausea, vomiting, and itching will also be noted. Patients will be called on postoperative day one to assess block duration and satisfaction with care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patient will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. The skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
| Arm | Type | Receives |
|---|---|---|
| Receives QL Block | Active comparator | Other: QL BlockIf the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance. |
| Receives Saline Skin Wheel No Block | Placebo comparator | Other: Saline Skin WheelThe skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than or equal to 18 years-old
- Undergoing elective hip arthroscopy. Exclusion Criteria
- Local anesthetic allergy
- Chlorhexidine allergy
- Patient weight < 40kg
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| QL BlockIf the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance. | Other | Receives QL Block |
| Saline Skin WheelThe skin will be cleaned with chlorhexidine. If the subject has been randomized to the "no block" group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point. | Other | Receives Saline Skin Wheel No Block |
Primary outcome
Opioid Consumption
Time frame: 24 hours
opioid consumption including intraoperative consumption exceeding 100µg of fentanyl and all postoperative opioid consumption in the postoperative anesthesia care unit (PACU).
6 secondary outcomes
Visual Analog Pain
Time frame: Immediately Post Operatively
Visual Analog Scale at Time of Post Anesthesia Care Unit Discharge
Time frame: 2 hours
Post Anesthesia Care Unit Duration
Time frame: 2 hours
Patient Satisfaction
Time frame: 24 hours
Opioid Related Side Effects
Time frame: 24 hours
Duration of Nerve Block
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Sylvia H Wilson, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL Block and Saline Skin Wheel in people with Surgery, run by Medical University of South Carolina 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 2 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: 24 hours). 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 2 Feb 2021.