Neuromuscular BlockadeNCT03410888
Popliteal Approach to Sciatic Nerve Block Is Not Inferior to Infragluteal Approach
A study testing Popliteal approach and Infragluteal approach in people with Neuromuscular Blockade, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a clinically significant difference in pain visual analogue sores (VAS) between the analgesia provided by the popliteal block and that of the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Popliteal approach and Infragluteal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jan 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- American Society of Anesthesiologists (ASA) Physical Status Scale I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
- Ages 18-85
- BMI ≤ 38 kg/m2
Who cannot join
- Chronic pain disorders
- Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
- Abuse of drugs or alcohol
- Allergies to any medication included in the study protocol
- Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
- Bilateral TKA surgeries
- History of significant psychiatric conditions that may affect patient assessment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Popliteal Approach to Sciatic Nerve Block Provides Postoperative Analgesia That Is Not Inferior to That of the Infragluteal Approach in Patients Undergoing Unilateral Total Knee Arthroplasty Under Spinal Anesthesia
Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a clinically significant difference in pain visual analogue sores (VAS) between the analgesia provided by the popliteal block and that of the infragluteal sciatic block in TKA surgery patients.
Read the detailed description
Sciatic nerve block provides clinically significant analgesic benefits following total knee arthroplasty (TKA). These benefits include a reduction in pain scores and decrease analgesic requirements.
Despite these benefits, sciatic nerve block has remained among the least performed peripheral nerve block by anesthesiologists. Some impediments relating to single shot sciatic nerve block (SSNB) that may cause anesthesiologists to avoid it include, patient discomfort due to needle passage through dense gluteal or thigh adipose and musculature, and unreliable success because of difficulty in localizing the sciatic nerve (particularly in obese patients).
Even in the current era of US guidance, sciatic nerve block remains a challenge. Despite its helpfulness, ultrasound technology remains hindered by an intrinsic limitation: a trade off between depth of penetration and image resolution; therefore, it works well for superficial blocks but becomes less useful when deep structures are imaged-ironically where this guidance is needed most. The challenge of anatomical depth, as in the case of the sciatic nerve, is one remaining challenge that dictates practical restrictions on the patterns of practice of ultrasound-guided regional anesthesia.
Actually, the recommendations of the Joint Committee for Education and Training composed of the American Society of Regional Anesthesia and the European Society of Regional Anesthesia cite the depth of block resulting in degradation of both ultrasound and needle image as the first among other causes that increase the level of difficulty of a nerve block.
As the sciatic nerve travels caudally in the body, it becomes more superficial with less thickness of tissue separating it from skin surface, making distal sciatic nerve block an attractive alternative. Indeed, both articular branches which provide sensory innervation to the knee joint as well as its muscular branches which provide innervation to the muscles surrounding knee joint most commonly arise from the sciatic nerve either at the knee level, or just above the knee or within the popliteal fossa.
Blockade of the sciatic nerve at the level of the popliteal fossa, commonly termed a popliteal block, is technically easier to perform than gluteal sciatic block and may even be associated with less risk of intravascular injection and nerve injury. Indeed, popliteal block has been reported to provide good postoperative analgesia in total knee replacement and other major knee surgery. However, the small posterior cutaneous nerve of the thigh, which supplies only the skin on the back of the thigh and knee, separates from the sciatic nerve proximally and variably in the gluteal region, and will be spared in more distal approaches. It is for this reason why many practitioners are hesitant to perform distal sciatic nerve blocks for TKA. However, the relative importance of the posterior cutaneous nerve of the thigh for post-operative analgesia following TKA is unknown and maybe clinically insignificant.
- Conditions
- Neuromuscular Blockade
- Being tested
- Popliteal approach, Infragluteal approach
- Keywords
- sciatic nerve block, infragluteal approach, popliteal approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal approachProcedure or surgery
Popliteal approach:
Under ultrasound guidance a 50 to 90 mm 22 G needle is inserted in and advanced to contact the target nerve until nerve movement is detected. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve.
Infragluteal approachProcedure or surgery
Infragluteal approach: The patients in this group will receive sciatic bock according to the approach described by Chan et al. Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The sciatic nerve is usually found anterior (deep) to the gluteus maximus muscle and lateral to the origin of the biceps femoris muscle at the ischial tuberosity as well as medial to the greater trochanter. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve.
| Study group | Role | What they receive |
|---|---|---|
| popliteal approach | Experimental | Blockade of the sciatic nerve at the level of the popliteal fossa. Receives: Procedure: Popliteal approach |
| infragluteal approach | Active comparator | Blocking the sciatic nerve at the subgluteal level. Receives: Procedure: Infragluteal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scores. The score at 6 hours will be considered as primary outcome.
Overall pain level as well as pain localized o the back of the knee will be assessed at rest and on movement (knee flexion) and will be quantified with a 100 mm VAS pain scale score, with 0 representing no pain and 100 representing the worst imaginable pain.
Measured: 6 hours
Secondary outcomes (1)
Sensory/Motor block onset assesment in the sciatic nerve distribution
The onset of sensory block will be assessed in the sciatic nerve distribution within 60 minutes of local anesthetic injection.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410888
- Sponsor's protocol ID
- 11-0306-B
- Status last verified
- Jan 2018
- First submitted
- 11 Feb 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
PubMed 9661553Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6. doi: 10.1016/s0883-5403(03)00198-0.
PubMed 12934209Bailey SL, Parkinson SK, Little WL, Simmerman SR. Sciatic nerve block. A comparison of single versus double injection technique. Reg Anesth. 1994 Jan-Feb;19(1):9-13.
PubMed 8148303
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popliteal Approach to Sciatic Nerve Block Provides Postoperative Analgesia That Is Not Inferior to That of the Infragluteal Approach in Patients Undergoing Unilateral Total Knee Arthroplasty Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03410888
- Acronym / sponsor ID
- 11-0306-B
- Conditions
- Neuromuscular Blockade
- Keywords
- sciatic nerve block, infragluteal approach, popliteal approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jan 2018 (actual)
- 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.
Study Hypothesis The investigators approach to demonstrate noninferiority of analgesia provided by popliteal block in TKA surgery will be based on a hypothesis of absence of a clinically significant difference in pain visual analogue sores (VAS) between the analgesia provided by the popliteal block and that of the infragluteal sciatic block in TKA surgery patients.
Detailed description
Sciatic nerve block provides clinically significant analgesic benefits following total knee arthroplasty (TKA). These benefits include a reduction in pain scores and decrease analgesic requirements.
Despite these benefits, sciatic nerve block has remained among the least performed peripheral nerve block by anesthesiologists. Some impediments relating to single shot sciatic nerve block (SSNB) that may cause anesthesiologists to avoid it include, patient discomfort due to needle passage through dense gluteal or thigh adipose and musculature, and unreliable success because of difficulty in localizing the sciatic nerve (particularly in obese patients).
Even in the current era of US guidance, sciatic nerve block remains a challenge. Despite its helpfulness, ultrasound technology remains hindered by an intrinsic limitation: a trade off between depth of penetration and image resolution; therefore, it works well for superficial blocks but becomes less useful when deep structures are imaged-ironically where this guidance is needed most. The challenge of anatomical depth, as in the case of the sciatic nerve, is one remaining challenge that dictates practical restrictions on the patterns of practice of ultrasound-guided regional anesthesia.
Actually, the recommendations of the Joint Committee for Education and Training composed of the American Society of Regional Anesthesia and the European Society of Regional Anesthesia cite the depth of block resulting in degradation of both ultrasound and needle image as the first among other causes that increase the level of difficulty of a nerve block.
As the sciatic nerve travels caudally in the body, it becomes more superficial with less thickness of tissue separating it from skin surface, making distal sciatic nerve block an attractive alternative. Indeed, both articular branches which provide sensory innervation to the knee joint as well as its muscular branches which provide innervation to the muscles surrounding knee joint most commonly arise from the sciatic nerve either at the knee level, or just above the knee or within the popliteal fossa.
Blockade of the sciatic nerve at the level of the popliteal fossa, commonly termed a popliteal block, is technically easier to perform than gluteal sciatic block and may even be associated with less risk of intravascular injection and nerve injury. Indeed, popliteal block has been reported to provide good postoperative analgesia in total knee replacement and other major knee surgery. However, the small posterior cutaneous nerve of the thigh, which supplies only the skin on the back of the thigh and knee, separates from the sciatic nerve proximally and variably in the gluteal region, and will be spared in more distal approaches. It is for this reason why many practitioners are hesitant to perform distal sciatic nerve blocks for TKA. However, the relative importance of the posterior cutaneous nerve of the thigh for post-operative analgesia following TKA is unknown and maybe clinically insignificant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| popliteal approach | Experimental | Procedure: Popliteal approachBlockade of the sciatic nerve at the level of the popliteal fossa. |
| infragluteal approach | Active comparator | Procedure: Infragluteal approachBlocking the sciatic nerve at the subgluteal level. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- American Society of Anesthesiologists (ASA) Physical Status Scale I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
- Ages 18-85
- BMI ≤ 38 kg/m2
Key exclusion criteria (8 listed)
- Chronic pain disorders
- Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
- Abuse of drugs or alcohol
- Allergies to any medication included in the study protocol
- Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
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 |
|---|---|---|
| Popliteal approachPopliteal approach: Under ultrasound guidance a 50 to 90 mm 22 G needle is inserted in and advanced to contact the target nerve until nerve movement is detected. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve. | Procedure or surgery | popliteal approach |
| Infragluteal approachInfragluteal approach: The patients in this group will receive sciatic bock according to the approach described by Chan et al. Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The sciatic nerve is usually found anterior (deep) to the gluteus maximus muscle and lateral to the origin of the biceps femoris muscle at the ischial tuberosity as well as medial to the greater trochanter. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve. | Procedure or surgery | infragluteal approach |
Primary outcome
Visual analogue pain scores. The score at 6 hours will be considered as primary outcome.
Time frame: 6 hours
Overall pain level as well as pain localized o the back of the knee will be assessed at rest and on movement (knee flexion) and will be quantified with a 100 mm VAS pain scale score, with 0 representing no pain and 100 representing the worst imaginable pain.
1 secondary outcome
Sensory/Motor block onset assesment in the sciatic nerve distribution
Time frame: 60 minutes
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 25 Jan 2018.
- Background: PubMed 9661553Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.
- Background: PubMed 12934209Cook P, Stevens J, Gaudron C. Comparing the effects of femoral nerve block versus femoral and sciatic nerve block on pain and opiate consumption after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):583-6. doi: 10.1016/s0883-5403(03)00198-0.
- Background: PubMed 8148303Bailey SL, Parkinson SK, Little WL, Simmerman SR. Sciatic nerve block. A comparison of single versus double injection technique. Reg Anesth. 1994 Jan-Feb;19(1):9-13.
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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.
Richard Brull, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Popliteal approach and Infragluteal approach in people with Neuromuscular Blockade, run by University Health Network, Toronto 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 4 inclusion and 8 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 25 Jan 2018. 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. 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?
Visual analogue pain scores. The score at 6 hours will be considered as primary outcome. (time frame: 6 hours). 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 NCT03410888, which also lists 3 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 25 Jan 2018.