Arthroplasty, Replacement, HipNCT02108847
Ultrasound Guided Fascia Iliaca Block for Pain Control After Elective Hip Replacement Surgery
A study testing .2% Ropivacaine, Saline and Fascia Iliaca Block in people with Arthroplasty, Replacement, Hip and Fascia Iliaca Block, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Fascia Iliaca Block
- What is being tested?
- .2% Ropivacaine, Saline and Fascia Iliaca Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists' (ASA) score I, II or III
- Scheduled for elective total hip arthroplasty
Who cannot join
- Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
- Neurologic disorder affecting the ability to sense pain
- Long term opioid use or chronic pain disorder
- History of drug or alcohol abuse
- Patient refusal
- Pregnancy
Show all 9Show fewer
- Revision procedures
- General anesthetic
- Psychiatric or mental conditions that may affect assessment of outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty
The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.
Read the detailed description
Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.
Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).
The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.
The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.
- Being tested
- .2% Ropivacaine, Saline, Fascia Iliaca Block
- Keywords
- Arthroplasty, Replacement, Hip, Pain, Postoperative, Nerve Block, Anesthesia, Regional, Fascia Iliaca Block, Ultrasound Guided
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
.2% RopivacaineDrug
SalineDrug
Fascia Iliaca BlockProcedure or surgery
Ultrasound-guided regional anesthesia block to the groin area.
| Study group | Role | What they receive |
|---|---|---|
| Fascia Iliaca Block - Ropivacaine | Experimental | Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine. Receives: Drug: .2% Ropivacaine; Procedure: Fascia Iliaca Block |
| Fascia Iliaca Block - Saline | Sham comparator | Ultrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline. Receives: Drug: Saline; Procedure: Fascia Iliaca Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption
Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison
Measured: 12 hours after surgery
Cumulative opioid consumption
Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison
Measured: 24 hours after surgery
Secondary outcomes (4)
Cumulative opioid consumption
Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison
Measured: 4, 8, and 48 hours after surgery
Verbal pain score (static and dynamic)
Pain score 0-10 with 10 being worst possible pain
Measured: PACU, 4, 8, 12, 24, and 48 hours after surgery
Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)
Presence of each side effect documented as "yes" or "no". Sedation will be assessed by the Ramsay Sedation Scale.
Measured: PACU, 4, 8, 12, 24, and 48 hours after surgery
Overall patient satisfaction
Satisfaction rated as: very dissatisfied, dissatisfied, neutral, satisfied, or very satisfied
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Responsible party
- Principal investigator, Jacelyn Larson, University of Saskatchewan
- Investigators
- Jacelyn Larson, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108847
- Sponsor's protocol ID
- Bio 13-314
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chelly JE, Ben-David B, Williams BA, Kentor ML. Anesthesia and postoperative analgesia: outcomes following orthopedic surgery. Orthopedics. 2003 Aug;26(8 Suppl):s865-71. doi: 10.3928/0147-7447-20030802-08.
PubMed 12934742Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
PubMed 9479711Mitchell ME. Regional anesthesia for hip surgery. Techniques in Regional Anesthesia and Pain Management 3(2): 94-106, 1999.
Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.
PubMed 2589650Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.
PubMed 19258967Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
PubMed 17413915Godoy Monzon D, Iserson KV, Vazquez JA. Single fascia iliaca compartment block for post-hip fracture pain relief. J Emerg Med. 2007 Apr;32(3):257-62. doi: 10.1016/j.jemermed.2006.08.011. Epub 2007 Feb 8.
PubMed 17394987
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Fascia Iliaca Block for Postoperative Analgesia After Elective Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02108847
- Acronym / sponsor ID
- Bio 13-314
- Keywords
- Arthroplasty, Replacement, Hip, Pain, Postoperative, Nerve Block, Anesthesia, Regional, Fascia Iliaca Block, Ultrasound Guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Apr 2014 (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.
The purpose of this study is to determine whether ultrasound guided fascia iliaca blocks performed before surgery help to reduce pain after elective total hip replacements.
Detailed description
Total hip arthroplasty is associated with moderate to severe pain in the acute postoperative period, which can increase the risk of postoperative complications such as thromboembolism, myocardial ischemia/infarction, pneumonia, poor wound healing, insomnia, and delirium.
Sensory innervation of the hip joint comes from a combination of peripheral nerves, including femoral, obturator, sciatic, superior gluteal, and nerve for the quadratus femoris muscle. Superficial innervation of the skin involved in incision for hip arthroplasty comes from the lateral femoral cutaneous nerve (LFCN).
The fascia iliaca block (FIB) was originally described in 1989 using a landmark technique. The ultrasound guided FIB was introduced in recent years, and has been shown to produce a better quality of block than the landmark technique. It appears to consistently block the femoral and LFCN, while being less successful in achieving consistent obturator blockade.
The FIB is effective for analgesia for hip fracture injuries in the emergency department. Thus far, there has been limited exploration into the potential use of this block as a tool for postoperative analgesia after elective hip arthroplasty. The potential benefits of this regional block, as with other regional techniques, include better analgesia, less opioid use and associated side effects, and an improved overall patient satisfaction with postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Iliaca Block - Ropivacaine | Experimental | Drug: .2% Ropivacaine, Procedure: Fascia Iliaca BlockUltrasound guided fascia iliaca block performed preoperatively with 40 mL of 0.2% ropivacaine. |
| Fascia Iliaca Block - Saline | Sham comparator | Drug: Saline, Procedure: Fascia Iliaca BlockUltrasound guided fascia iliaca block performed preoperatively with 40 mL of Saline. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' (ASA) score I, II or III
- Scheduled for elective total hip arthroplasty
Key exclusion criteria (9 listed)
- Contraindication to regional anesthesia (allergy to local anesthetic, coagulopathy, infection or malignancy in the area)
- Neurologic disorder affecting the ability to sense pain
- Long term opioid use or chronic pain disorder
- History of drug or alcohol abuse
- Patient refusal
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 |
|---|---|---|
| .2% Ropivacaine | Drug | Fascia Iliaca Block - Ropivacaine |
| Saline | Drug | Fascia Iliaca Block - Saline |
| Fascia Iliaca BlockUltrasound-guided regional anesthesia block to the groin area. | Procedure or surgery | Fascia Iliaca Block - Ropivacaine, Fascia Iliaca Block - Saline |
Primary outcome
Cumulative opioid consumption
Time frame: 12 hours after surgery
Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison
Cumulative opioid consumption
Time frame: 24 hours after surgery
Dilaudid will be used for analgesia postoperatively. If there is a contraindication to Dilaudid, another opioid will be ordered for analgesia, and doses will subsequently be converted back to Dilaudid equivalent doses for comparison
4 secondary outcomes
Cumulative opioid consumption
Time frame: 4, 8, and 48 hours after surgery
Verbal pain score (static and dynamic)
Time frame: PACU, 4, 8, 12, 24, and 48 hours after surgery
Opioid side effect (nausea/vomiting, pruritus, constipation, urinary retention, sedation)
Time frame: PACU, 4, 8, 12, 24, and 48 hours after surgery
Overall patient satisfaction
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Results publication: PubMed 12934742Chelly JE, Ben-David B, Williams BA, Kentor ML. Anesthesia and postoperative analgesia: outcomes following orthopedic surgery. Orthopedics. 2003 Aug;26(8 Suppl):s865-71. doi: 10.3928/0147-7447-20030802-08.
- Results publication: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Results publication: PubMed 9479711Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
- Results publicationMitchell ME. Regional anesthesia for hip surgery. Techniques in Regional Anesthesia and Pain Management 3(2): 94-106, 1999.
- Results publication: PubMed 2589650Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.
- Results publication: PubMed 19258967Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.
- Results publication: PubMed 17413915Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
- Results publication: PubMed 17394987Godoy Monzon D, Iserson KV, Vazquez JA. Single fascia iliaca compartment block for post-hip fracture pain relief. J Emerg Med. 2007 Apr;32(3):257-62. doi: 10.1016/j.jemermed.2006.08.011. Epub 2007 Feb 8.
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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.
Jacelyn Larson, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing .2% Ropivacaine, Saline and Fascia Iliaca Block in people with Arthroplasty, Replacement, Hip and Fascia Iliaca Block, run by University of Saskatchewan at 1 site in Canada.
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 2 inclusion and 9 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 15 Nov 2016. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative opioid consumption (time frame: 12 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108847, which also lists 8 linked publications.
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 15 Nov 2016.