Anesthesia, LocalPhase 4NCT02557386
Optimal Volume of Bupivacaine in Adductor Canal Nerve Block
A Phase 4 study testing Levobupivacaine 5 mL, Levobupivacaine 10 mL and Levobupivacaine 15 mL in people with Anesthesia, Local, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Levobupivacaine 5 mL, Levobupivacaine 10 mL and Levobupivacaine 15 mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- Jan 2016to Mar 2017
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex
- ASA status I or II
- BMI between 20 and 34 kg/m2
- Cruciate ligament of the knee reconstructive surgery
- No contraindications to general and regional anesthesia
Who cannot join
- Chronic pain more than 3 months
- Drug abuse
- Chronic use of analgesic drugs (more than 3 months)
- Psychiatric illness
- Peripheral neuropathy
- Drug allergy
- Severe gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
Fernando R Altermatt, MSc, 56-2-23543270, fernando.altermatt@gmail.com
Sebastian Paredes, MD, 56-2-23543270, sparedese@gmail.com
About this study
Official title: Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery.
Read the detailed description
The complex knee surgery has been associated with severe postoperative pain. Different analgesic techniques for postoperative management of this increasingly common surgery, with main purpose of adequately control pain, minimizing adverse effects and seeking early rehabilitation.
Currently, the most used technique is the continuous femoral nerve block, which is able to control postoperative pain well, but has the limitation that also produces motor blockade, decreasing quadriceps strength up to 80%, increasing the number of falls and delaying early mobilization after surgery. On the other hand, the adductor canal nerve block is an alternative as it is considered a purely sensitive block. The nerves that are in this channel are the saphenous adductor nerve, posterior branches of the obturator nerve, medial vast nerve, sometimes the medial cutaneous nerve and anterior branches of the obturator nerve and the vast medial nerve.
With regard to the adductor canal block, current literature supports analgesic effect comparable to femoral nerve block with less motor block than femoral nerve block. However, there is no clarity regarding the ideal concentration and volume of local anesthetics to use. Volumes ranging from 5 to 30 ml have been used in different studies. For example, using 20 mL of local anesthetic in femoral nerve block has produced scattering of anesthetic that has blocked motor branches.
The investigators objective is to determine which volume of levobupivacaine 0.25% is necessary to produce analgesia and sensitive blockade while minimizing motor blockade in adductor canal nerve block in patients undergoing cruciate ligament reconstruction surgery.
- Conditions
- Anesthesia, Local
- Being tested
- Levobupivacaine 5 mL, Levobupivacaine 10 mL, Levobupivacaine 15 mL, Levobupivacaine 20 mL, Levobupivacaine 25 mL
- Keywords
- Cruciate ligament surgery, Adductor canal, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine 5 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 5 mL in adductor canal nerve block
Levobupivacaine 10 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 10 mL in adductor canal nerve block
Levobupivacaine 15 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 15 mL in adductor canal nerve block
Levobupivacaine 20 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 20 mL in adductor canal nerve block
Levobupivacaine 25 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 25 mL in adductor canal nerve block
Levobupivacaine 30 mLDrug
Also called Chirocaine
Levobupivacaine 0.25% 30 mL in adductor canal nerve block
| Study group | Role | What they receive |
|---|---|---|
| A Levobupivacaine 5 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 5 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 5 mL |
| B Levobupivacaine 10 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 10 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 10 mL |
| C Levobupivacaine 15 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 15 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 15 mL |
| D Levobupivacaine 20 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 20 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 20 mL |
| E Levobupivacaine 25 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 25 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 25 mL |
| F Levobupivacaine 30 mL | Experimental | Adductor canal nerve block with levobupivacaine 0.25% 30 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. Receives: Drug: Levobupivacaine 30 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps motor force measured in kg*m/sec2
Using a dynamometer in anterior tibial muscle
Measured: Before nerve block (basal) and 24 hours after surgery
Secondary outcomes (5)
Pain
Using visual analogue scale, static and dynamic evaluation, scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery
Rescue analgesia
Lidocaine 1% bolus through nerve block catheter and opioid use, measured in mg
Measured: 24 hours and 48 hours after surgery
Patient satisfaction
Using a 5 point scale from 1 (very unsatisfied) to 5 (very satisfied)
Measured: 48 hours after surgery
Change in quadriceps force measured by 30-second chair stand test
Using 30-second chair stand test, how many times patient can stand up in 30 seconds, number of times is recorded
Measured: Before nerve block (basal) and 24 hours after surgery
Sensitivity block
Using a sensitivity scale ranging from 0 (no sensitivity), 1 (paresthesias) and 2 (normal sensitivity. Measured with needle prick and cold sensitivity.
Measured: 30 minutes after adductor canal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando R Altermatt, MD, Principal investigator, Associate Professor Ordinary Category
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557386
- Sponsor's protocol ID
- 15-001
- Status last verified
- Oct 2016
- First submitted
- 11 Sep 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.
PubMed 12717143Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.
PubMed 24401802Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
PubMed 24401769Allen 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 9661553Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.
PubMed 20881593Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
PubMed 21394001Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
PubMed 19046884Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
PubMed 20889937Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.
PubMed 17196495Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
PubMed 22834681Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.
PubMed 17720129Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
PubMed 19920424Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
PubMed 21039357
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Volume of Bupivacaine in Adductor Canal Nerve Block in Patients Undergoing Unilateral Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT02557386
- Acronym / sponsor ID
- 15-001
- Conditions
- Anesthesia, Local
- Keywords
- Cruciate ligament surgery, Adductor canal, Nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 23 Sep 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.
To establish adequate volume of levobupivacaine 0.25% in adductor canal nerve block in unilateral cruciate ligament of the knee reconstruction surgery.
Detailed description
The complex knee surgery has been associated with severe postoperative pain. Different analgesic techniques for postoperative management of this increasingly common surgery, with main purpose of adequately control pain, minimizing adverse effects and seeking early rehabilitation.
Currently, the most used technique is the continuous femoral nerve block, which is able to control postoperative pain well, but has the limitation that also produces motor blockade, decreasing quadriceps strength up to 80%, increasing the number of falls and delaying early mobilization after surgery. On the other hand, the adductor canal nerve block is an alternative as it is considered a purely sensitive block. The nerves that are in this channel are the saphenous adductor nerve, posterior branches of the obturator nerve, medial vast nerve, sometimes the medial cutaneous nerve and anterior branches of the obturator nerve and the vast medial nerve.
With regard to the adductor canal block, current literature supports analgesic effect comparable to femoral nerve block with less motor block than femoral nerve block. However, there is no clarity regarding the ideal concentration and volume of local anesthetics to use. Volumes ranging from 5 to 30 ml have been used in different studies. For example, using 20 mL of local anesthetic in femoral nerve block has produced scattering of anesthetic that has blocked motor branches.
The investigators objective is to determine which volume of levobupivacaine 0.25% is necessary to produce analgesia and sensitive blockade while minimizing motor blockade in adductor canal nerve block in patients undergoing cruciate ligament reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A Levobupivacaine 5 mL | Experimental | Drug: Levobupivacaine 5 mLAdductor canal nerve block with levobupivacaine 0.25% 5 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
| B Levobupivacaine 10 mL | Experimental | Drug: Levobupivacaine 10 mLAdductor canal nerve block with levobupivacaine 0.25% 10 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
| C Levobupivacaine 15 mL | Experimental | Drug: Levobupivacaine 15 mLAdductor canal nerve block with levobupivacaine 0.25% 15 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
| D Levobupivacaine 20 mL | Experimental | Drug: Levobupivacaine 20 mLAdductor canal nerve block with levobupivacaine 0.25% 20 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
| E Levobupivacaine 25 mL | Experimental | Drug: Levobupivacaine 25 mLAdductor canal nerve block with levobupivacaine 0.25% 25 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
| F Levobupivacaine 30 mL | Experimental | Drug: Levobupivacaine 30 mLAdductor canal nerve block with levobupivacaine 0.25% 30 mL and perineural catheter placement, an elastomeric pump with bupivacaine 0.1% at a rate of 5 ml/hr will be placed after surgery for continuous nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male sex
- ASA status I or II
- BMI between 20 and 34 kg/m2
- Cruciate ligament of the knee reconstructive surgery
- No contraindications to general and regional anesthesia
Key exclusion criteria (7 listed)
- Chronic pain more than 3 months
- Drug abuse
- Chronic use of analgesic drugs (more than 3 months)
- Psychiatric illness
- Peripheral neuropathy
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 |
|---|---|---|
| Levobupivacaine 5 mLAlso: ChirocaineLevobupivacaine 0.25% 5 mL in adductor canal nerve block | Drug | A Levobupivacaine 5 mL |
| Levobupivacaine 10 mLAlso: ChirocaineLevobupivacaine 0.25% 10 mL in adductor canal nerve block | Drug | B Levobupivacaine 10 mL |
| Levobupivacaine 15 mLAlso: ChirocaineLevobupivacaine 0.25% 15 mL in adductor canal nerve block | Drug | C Levobupivacaine 15 mL |
| Levobupivacaine 20 mLAlso: ChirocaineLevobupivacaine 0.25% 20 mL in adductor canal nerve block | Drug | D Levobupivacaine 20 mL |
| Levobupivacaine 25 mLAlso: ChirocaineLevobupivacaine 0.25% 25 mL in adductor canal nerve block | Drug | E Levobupivacaine 25 mL |
| Levobupivacaine 30 mLAlso: ChirocaineLevobupivacaine 0.25% 30 mL in adductor canal nerve block | Drug | F Levobupivacaine 30 mL |
Primary outcome
Change in quadriceps motor force measured in kg*m/sec2
Time frame: Before nerve block (basal) and 24 hours after surgery
Using a dynamometer in anterior tibial muscle
5 secondary outcomes
Pain
Time frame: Before surgery, 30 minutes after nerve block, one hour after surgery, 48 hours after surgery
Rescue analgesia
Time frame: 24 hours and 48 hours after surgery
Patient satisfaction
Time frame: 48 hours after surgery
Change in quadriceps force measured by 30-second chair stand test
Time frame: Before nerve block (basal) and 24 hours after surgery
Sensitivity block
Time frame: 30 minutes after adductor canal block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Background: PubMed 12717143Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13. doi: 10.1097/00000542-200305000-00024.
- Background: PubMed 24401802Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 24401769Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
- 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 20881593Hadzic A, Houle TT, Capdevila X, Ilfeld BM. Femoral nerve block for analgesia in patients having knee arthroplasty. Anesthesiology. 2010 Nov;113(5):1014-5. doi: 10.1097/ALN.0b013e3181f4b43d. No abstract available.
- Background: PubMed 21394001Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
- Background: PubMed 19046884Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
- Background: PubMed 20889937Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
- Background: PubMed 17196495Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.
- Background: PubMed 22834681Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.
- Background: PubMed 17720129Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.
- 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.
Fernando R Altermatt, MD principal investigator
Associate Professor Ordinary Category
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine 5 mL, Levobupivacaine 10 mL and Levobupivacaine 15 mL in people with Anesthesia, Local, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 5 inclusion and 7 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 12 Oct 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 Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fernando R Altermatt, MD (56-2-23543270, falterma@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps motor force measured in kg*m/sec2 (time frame: Before nerve block (basal) and 24 hours after surgery). 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 NCT02557386, which also lists 25 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 12 Oct 2016.