Nerve BlockPhase 4NCT02957903
Sensory Distribution of Lateral Femoral Cutaneous Nerve Block
A Phase 4 study testing Ropivacaine and Isotonic Saline in people with Nerve Block and Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Anesthesia, Local, Pain, Postoperative
- What is being tested?
- Ropivacaine and Isotonic Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Dec 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who have given their written consent after understanding the content and limitations og the study.
- ASA 1-2.
- BMI ≥18 and ≤ 30
Who cannot join
- Participants who can not cooperate in the study.
- Participant who can not speak or understand danish.
- Allergies to the drugs used in the study.
- Alcohol consumption that exceeds 21 units per week.
- Drug abuse by the investigators judgement.
- Daily consumption of prescription required analgesic drugs within the last four weeks.
Show all 10Show fewer
- Consumption of over the counter analgesic drugs within the last 48 hours.
- Neuromuscular defects, former surgery or trauma to the lower extremities.
- Diabetes mellitus.
- Pregnant women (women in the fertile age must have used safe contraception and test negative with a urine-HCG to be able to participate in the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Distribution of Lateral Femoral Cutaneous Nerve Block - A Randomized, Blinded, Paired Trial in Healthy Volunteers
The purpose of this study is to investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be conducted in healthy volunteers in a blinded, randomized paired study.
Read the detailed description
Background:
Total hip arthroplasties may be associated with moderate to intense postoperative pain. It is essential that pain treatment, besides being analgesic, has a minimum of side effects, especially those opioid-related, in order to achieve low morbidity, high patient satisfaction and to encourage the functional rehabilitation.
Currently, there is no "gold standard" for pain treatment after THA, and there exists a large variety of treatment options. Some patients who have undergone THA, can be difficult to sufficiently treat with conventional analgesics without reaching additional morphine doses where side effects are unacceptable. It is therefore important to explore other treatment options, including nerve blockade.
Nerve blocks have previously been used after THA operations, but have been hampered by the fact, that the nerve blocks have an effect on the motorial nerve, inhibiting early mobilization and possibly increasing tendencies to fall when mobilized. LFCN is purely sensorial and can therefore relieve the patient of pain without influencing the early mobilization. In addition, the application of nerve blocks is very easy and virtually without complications.
In two previous trials, the investigators have studied the effect of LFCN blocks in pain treatment after THA. In the recent study, the LFCN block was applied in patients after THA, who still had visual analogue scale (VAS) mobilization pain > 40 mm when lifting their leg stretched. The LFCN block alleviated significantly the average pain at group level. Meanwhile 42% of patients in the study had no or limited effect of the block. The reason for this may be due to the fact, that LFCN block does not cover all types of pain after THA, but also the fact, that the nerve innervation area has individual differences in the anatomical distribution. It is therefore relevant to describe the anatomical distribution of a LFCN block in order to determine whether the variations in anatomy is a contributing factor of the high number of patients with no effect of the blockade.
An earlier study investigated the proportion of the incisional line associated with total hip arthroplasty that was covered by the LFCN block. However the study was not blinded or randomized, and the description of the anatomical distribution of the block was inadequate.
Methods:
Prior to applying the nerve block, the measurement methods are tested and baseline values are registered for each leg of each participant.
The effect of a nerve block in healthy individuals can be studied by a number of validated measurement techniques. These techniques consist of mapping the affected anatomical area with temperature discrimination test (cold sensation) by using alcohol soaked gauze and pin-prick test by using a Von Frey filament, and of a pain stimulation test with determination of the heat pain threshold (Heat Pain Detection Threshold, HPDT) and pain during tonic heat-stimulation of the skin (VAS tonic heat stimulation). The duration and distribution of the sensory block is thus evaluated by high precision.
It is furthermore important to investigate whether the nerve blockade affects N. Femoralis' motorial innervation by testing m.Quadriceps' motorial function.
Course of study:
- Baseline values are measured.
- An orthopedic surgeon draws two hypothetical incisional lines corresponding to the posterior and to the anterior-lateral access to the hip joint on each leg of each participant. The incisional lines will be drawn with UV paint only visible under UV light. No other than the person drawing the lines and the participant will see where the lines are drawn.
- An ultrasound guided LFCN block is applied by a specialist in anesthesia. Each trial participant will get an injection of Ropivacaine (active ingredient) in one leg and an injection of isotonic NaCl (placebo) in the other leg. Neither trial participant, doctors or investigator will know which treatment the participant receives in which leg, that is the trial is blinded.
- After the LFCN block is applied a line called "Line A" is drawn on each leg. Line A goes from trochanter major to the femoral lateral epicondyle and is extended cranial. A line 0A is drawn perpendicular on line A at the trochanter major point. 5 cm above line 0A, is line -1A drawn up to -3A, and 5 cm below line 0A is line 1A drawn, and so forth to line 15A is reached.
- One hour after the nerve block is applied to the right leg, the motorial and sensorial tests will be carried out on each leg, and the outcome will be registered and documented with photography. The test will be carried out on the right leg and then on the left leg in following order:
- Maximum isometric voluntary contraction
- Temperature discrimination test (alcohol soaked gauze)
- Pin-prick (Von Frey filament)
- Photo documentation
- Drawing of the incisional lines under UV-light
- Photo documentation
- Measurement of the incisional lines
- Heat pain detection threshold test
- Pain stimulation test.
The subjects will be monitored with blood pressure, pulse oximetry and ECG during the trial. The study extends for each participant from the introductory conversation to all testing is complete.
- Being tested
- Ropivacaine, Isotonic Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called 8 ml Ropivacaine 0.75 %
All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
Isotonic SalineDrug
Also called 8 ml isotonic Saline
All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Injection around the lateral femoral cutaneous nerve:
8 ml Ropivacaine 0.75 %. Receives: Drug: Ropivacaine |
| Treatment B | Placebo comparator | Injection around the lateral femoral cutaneous nerve:
8 ml isotonic Saline. Receives: Drug: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation
Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.
Measured: 1 hour post-block
Secondary outcomes (14)
Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by cold sensation
Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.
Measured: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) assessed by pin-prick
Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).
Measured: 1 hour post-block
Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by pin-prick
Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).
Measured: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach)
The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach)
The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterior-lateral approach)
The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterior-lateral approach)
The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach)
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach)
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function assessed (no pain detection) by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach)
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach)
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
Estimation of the area with sensory loss assessed by cold sensation
Estimation of the area with sensory loss (including photo documentation) assessed by cold sensation (alcohol soaked gauze) on the side given Ropivacaine and the side given saline. Marked with the incisions.
Measured: 1 hour post-block
Estimation of the area with sensory loss assessed by pin-prick
Estimation of the area with sensory loss (including photo documentation) assessed by pin-prick (Von Frey filament) on the side given Ropivacaine and the side given saline. Marked with the incisions.
Measured: 1 hour post-block
The difference in MVIC (maximal voluntary isometric contraction) of the leg
The difference in MVIC (maximal voluntary isometric contraction) of the leg between the side given Ropivacaine versus the side given saline.
Measured: 1 hour post-block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital
- Responsible party
- Sponsor
- Investigators
- Daniel Hägi-Pedersen, MD, PhD, Study chair, Naestved HospitalKasper H Thybo, MD, Principal investigator, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957903
- Sponsor's protocol ID
- SM1-KHT-2016
- Other IDs
- 2016-002643-41, 2016
- Status last verified
- Oct 2016
- First submitted
- 31 Oct 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: If data is requested by an editor it will be allowed
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
PubMed 14667752Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.
PubMed 25599296Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.
PubMed 16288617Thybo KH, Schmidt H, Hagi-Pedersen D. Effect of lateral femoral cutaneous nerve-block on pain after total hip arthroplasty: a randomised, blinded, placebo-controlled trial. BMC Anesthesiol. 2016 Mar 23;16:21. doi: 10.1186/s12871-016-0183-4.
PubMed 27006014Thybo KH, Mathiesen O, Dahl JB, Schmidt H, Hagi-Pedersen D. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomised trial. Acta Anaesthesiol Scand. 2016 Oct;60(9):1297-305. doi: 10.1111/aas.12764. Epub 2016 Jul 18.
PubMed 27426231Davies A, Crossley A, Harper M, O'Loughlin E. Lateral cutaneous femoral nerve blockade-limited skin incision coverage in hip arthroplasty. Anaesth Intensive Care. 2014 Sep;42(5):625-30. doi: 10.1177/0310057X1404200513.
PubMed 25233177
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Distribution of Lateral Femoral Cutaneous Nerve Block - A Randomized, Blinded, Paired Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02957903
- Acronym / sponsor ID
- SM1-KHT-2016
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Naestved Hospital
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Nov 2016 (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 investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be conducted in healthy volunteers in a blinded, randomized paired study.
Detailed description
Background:
Total hip arthroplasties may be associated with moderate to intense postoperative pain. It is essential that pain treatment, besides being analgesic, has a minimum of side effects, especially those opioid-related, in order to achieve low morbidity, high patient satisfaction and to encourage the functional rehabilitation.
Currently, there is no "gold standard" for pain treatment after THA, and there exists a large variety of treatment options. Some patients who have undergone THA, can be difficult to sufficiently treat with conventional analgesics without reaching additional morphine doses where side effects are unacceptable. It is therefore important to explore other treatment options, including nerve blockade.
Nerve blocks have previously been used after THA operations, but have been hampered by the fact, that the nerve blocks have an effect on the motorial nerve, inhibiting early mobilization and possibly increasing tendencies to fall when mobilized. LFCN is purely sensorial and can therefore relieve the patient of pain without influencing the early mobilization. In addition, the application of nerve blocks is very easy and virtually without complications.
In two previous trials, the investigators have studied the effect of LFCN blocks in pain treatment after THA. In the recent study, the LFCN block was applied in patients after THA, who still had visual analogue scale (VAS) mobilization pain > 40 mm when lifting their leg stretched. The LFCN block alleviated significantly the average pain at group level. Meanwhile 42% of patients in the study had no or limited effect of the block. The reason for this may be due to the fact, that LFCN block does not cover all types of pain after THA, but also the fact, that the nerve innervation area has individual differences in the anatomical distribution. It is therefore relevant to describe the anatomical distribution of a LFCN block in order to determine whether the variations in anatomy is a contributing factor of the high number of patients with no effect of the blockade.
An earlier study investigated the proportion of the incisional line associated with total hip arthroplasty that was covered by the LFCN block. However the study was not blinded or randomized, and the description of the anatomical distribution of the block was inadequate.
Methods:
Prior to applying the nerve block, the measurement methods are tested and baseline values are registered for each leg of each participant.
The effect of a nerve block in healthy individuals can be studied by a number of validated measurement techniques. These techniques consist of mapping the affected anatomical area with temperature discrimination test (cold sensation) by using alcohol soaked gauze and pin-prick test by using a Von Frey filament, and of a pain stimulation test with determination of the heat pain threshold (Heat Pain Detection Threshold, HPDT) and pain during tonic heat-stimulation of the skin (VAS tonic heat stimulation). The duration and distribution of the sensory block is thus evaluated by high precision.
It is furthermore important to investigate whether the nerve blockade affects N. Femoralis' motorial innervation by testing m.Quadriceps' motorial function.
Course of study:
- Baseline values are measured.
- An orthopedic surgeon draws two hypothetical incisional lines corresponding to the posterior and to the anterior-lateral access to the hip joint on each leg of each participant. The incisional lines will be drawn with UV paint only visible under UV light. No other than the person drawing the lines and the participant will see where the lines are drawn.
- An ultrasound guided LFCN block is applied by a specialist in anesthesia. Each trial participant will get an injection of Ropivacaine (active ingredient) in one leg and an injection of isotonic NaCl (placebo) in the other leg. Neither trial participant, doctors or investigator will know which treatment the participant receives in which leg, that is the trial is blinded.
- After the LFCN block is applied a line called "Line A" is drawn on each leg. Line A goes from trochanter major to the femoral lateral epicondyle and is extended cranial. A line 0A is drawn perpendicular on line A at the trochanter major point. 5 cm above line 0A, is line -1A drawn up to -3A, and 5 cm below line 0A is line 1A drawn, and so forth to line 15A is reached.
- One hour after the nerve block is applied to the right leg, the motorial and sensorial tests will be carried out on each leg, and the outcome will be registered and documented with photography. The test will be carried out on the right leg and then on the left leg in following order:
- Maximum isometric voluntary contraction
- Temperature discrimination test (alcohol soaked gauze)
- Pin-prick (Von Frey filament)
- Photo documentation
- Drawing of the incisional lines under UV-light
- Photo documentation
- Measurement of the incisional lines
- Heat pain detection threshold test
- Pain stimulation test.
The subjects will be monitored with blood pressure, pulse oximetry and ECG during the trial. The study extends for each participant from the introductory conversation to all testing is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: RopivacaineInjection around the lateral femoral cutaneous nerve: 8 ml Ropivacaine 0.75 %. |
| Treatment B | Placebo comparator | Drug: Isotonic SalineInjection around the lateral femoral cutaneous nerve: 8 ml isotonic Saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who have given their written consent after understanding the content and limitations og the study.
- ASA 1-2.
- BMI ≥18 and ≤ 30
Key exclusion criteria (10 listed)
- Participants who can not cooperate in the study.
- Participant who can not speak or understand danish.
- Allergies to the drugs used in the study.
- Alcohol consumption that exceeds 21 units per week.
- Drug abuse by the investigators judgement.
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 |
|---|---|---|
| RopivacaineAlso: 8 ml Ropivacaine 0.75 %All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control. | Drug | Treatment A |
| Isotonic SalineAlso: 8 ml isotonic SalineAll 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control. | Drug | Treatment B |
Primary outcome
Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.
14 secondary outcomes
Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by cold sensation
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) assessed by pin-prick
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (anterior-lateral approach) assessed by pin-prick
Time frame: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterior-lateral approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterior-lateral approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function assessed (no pain detection) by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach)
Time frame: 1 hour post-block
The percentage of participants with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach)
Time frame: 1 hour post-block
Estimation of the area with sensory loss assessed by cold sensation
Time frame: 1 hour post-block
Estimation of the area with sensory loss assessed by pin-prick
Time frame: 1 hour post-block
The difference in MVIC (maximal voluntary isometric contraction) of the leg
Time frame: 1 hour post-block
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 26 Jan 2017.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 14667752Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
- Background: PubMed 25599296Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.
- Background: PubMed 16288617Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.
- Background: PubMed 27006014Thybo KH, Schmidt H, Hagi-Pedersen D. Effect of lateral femoral cutaneous nerve-block on pain after total hip arthroplasty: a randomised, blinded, placebo-controlled trial. BMC Anesthesiol. 2016 Mar 23;16:21. doi: 10.1186/s12871-016-0183-4.
- Background: PubMed 27426231Thybo KH, Mathiesen O, Dahl JB, Schmidt H, Hagi-Pedersen D. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomised trial. Acta Anaesthesiol Scand. 2016 Oct;60(9):1297-305. doi: 10.1111/aas.12764. Epub 2016 Jul 18.
- Background: PubMed 25233177Davies A, Crossley A, Harper M, O'Loughlin E. Lateral cutaneous femoral nerve blockade-limited skin incision coverage in hip arthroplasty. Anaesth Intensive Care. 2014 Sep;42(5):625-30. doi: 10.1177/0310057X1404200513.
- Individual participant dataSharing planned: Yes. If data is requested by an editor it will be allowed
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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.
Daniel Hägi-Pedersen, MD, PhD study chair
Naestved Hospital
Kasper H Thybo, MD principal investigator
Naestved Hospital
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 Ropivacaine and Isotonic Saline in people with Nerve Block and Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
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 3 inclusion and 10 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 26 Jan 2017. 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 Denmark. 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.
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?
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?
Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation (time frame: 1 hour post-block). 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 NCT02957903, which also lists 7 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 26 Jan 2017.