Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102811
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-10-22
Brief Title:
Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HALF
Brief Summary:
Fascia iliaca compartment block FICB is a documented option for postoperative analgesia for total hip arthroplasty THA surgery FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease however it causes quadriceps motor weakness Current available motor sparing techniques are not as effective as FICB for analgesia Low concentration local anesthetics LCLA are used with excellent results for pain control with no or minimum motor block effect in other scenarios highlighted in obstetric anesthesia and techniques epidural anesthesia for instance This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia while at the same time avoiding motor blockade and muscle weakness The investigators hypothesize that LCLA-FICB when compared to conventional high concentration local anesthetics HCLA FICB provides similar postoperative analgesia in the first 24 hours following primary THA while at the same time preserving quadriceps muscle group strength
Detailed Description:
Significance There are no published prospective randomized controlled trials evaluating LCLA blocks for THA As THA is the second most frequent type of surgery requiring hospitalization and has the prediction to increase its incidence for the next years there is significant importance in investigations about interventions which may improve its recovery in an outpatient regime A postoperative analgesic technique that offers better pain control has less adverse effects reduces the opioid analgesia requirement and is safer may have additional impact on decreasing health care costs and may lead to an enhanced recovery and better quality of life for THA patients
Objectives The primary objective will be to evaluate efficacy of LCLA-FICB in comparison to HCLA-FICB for patients undergoing primary THA in terms of pain scores and opioid consumption
The secondary objective is to assess postoperative opioid related side effects and ipsilateral quadriceps weakness between those two postoperative analgesia techniques
Hypothesis The LCLA-FICB in comparison to HCLA-FICB provides non-inferior postoperative analgesia in the first 24 hours following primary THA while at the same time preserving quadriceps muscle group strength
Methods Study type This will be a randomized controlled prospective trial blinded for patient and evaluator in patients undergoing primary THA at Sinai Health After Hospitals Ethics in Research Board approval the recruitment will begin Patients will be assessed about their eligibility for participating and after plain clear information about the study interventions they will or will not authorize their inclusion and data collection through the signature of a written consent
Perioperative management and interventions The subjects will have their surgeries booked in advance and they will be submitted to the pre anesthesia consult at the Pre-Admission Unit PAU a few days before the surgery The study proposal will be explained to the patients on that occasion and they will receive the consent form with the information about the study that they will bring home to review They will have the time between the pre anesthesia assessment and the surgery at least 24 hours to review and consent to the study
Patients will be randomized to one of the two groups using a computer-generated random numbers table The randomization will be done before the beginning of the study and will define which study number is going to be managed as intervention group LCLA-FICB or control group HCLA-FICB Each patient will receive a study number following the order of their entrance on the study and that number will be already linked for one of the two groups Closed envelopes will be prepared ahead of time and each of them will have the name of the group related to its study number Once the patient is included the research coordinator will check inside the envelope which group the patient is randomized to in order to prepare the solution for the FICB LCLA or HCLA A list with the study numbers and the randomization will be kept by the research coordinator under password protection and will be shared with other researches only after all data collection is finished The patient the research assistant the professional who performs the postoperative assessments and the professional providing anesthesia care to the patient will be blinded to which group each patient is randomized to
All patients will receive the same perioperative management Patients will initially be brought to a dedicated block room where a safety checklist will be performed by the block room team Standard Canadian Anesthesia Society monitoring will be provided Mild sedation with Midazolam 05-2mg and Fentanyl 25-150mcg might be administered for anxiolysis and analgesia After proper cleaning of the ipsilateral hip area under sterile technique and ultrasound guidance Sonosite Edge II ultrasound machine a supra-inguinal FICB will be performed21 Patients in the LCLA-FICB group will receive a block with 50 ml of Ropivacaine 0075 with epinephrine 1200000 Patients in the control group HCLA-FICB will receive a supra-inguinal FICB block with 50 ml of Ropivacaine 025 with epinephrine 1200000 concentration of local anesthetics used routinely for this PNB
After the FICB block is performed all patients will receive standard spinal anesthesia using Mepivacaine 2 x 35 ml with fentanyl 15 mcg and preservative free morphine 100 mcg All intraoperative opioids administered will be recorded In the intra-operative period each patient will receive IV Cefazolin 2-3 g Tranexamic acid 20 mgkg Dexamethasone 01 mgkg and Ondansetron 4 mg
Standard oral analgesic scheme will be prescribed to every patient Acetaminophen 650 - 1000 mg QID Celecoxib 100 - 200 mg BID Hydromorphone 1 - 2 mg PRN Q2Hs Hydromorphone 02 - 04 mg IV PRN Q1H
Outcomes Patients will be assessed at 1-2h before surgery for demographic information age weight height body mass index gender ASA functional status and baseline pain scores and average opioid consumption
After the surgery patients will be assessed in person by a research team member blinded to which group the patient was randomized to on 4 8 24 and 48 hours after the spinal anesthesia moment as following
4 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
8 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications
24 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
48 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
The primary end point of the study is the degree of muscle weakness on 4 hours after surgery Secondary outcome parameters will include the following total opioid consumption at 48 hours pain scores dermatomes sensation impairment nerve block related complicaitonsand hospital length of stay
Pain will be measured using the numerical rating scale NRS for pain 0 no pain at all 10 worst pain For the 4- and 8-hours assessments the patients will be asked to rate their lowest and highest pain scores for the last 4 and 8 hours From the rest of the moments they will be asked to rate their pain at rest and at movement from sitting position to standing up Opioid usage will be measure in oral morphine equivalent doses Quadriceps weakness will be evaluated using the Muscle Strength Grading Oxford Scale by a member of the research team22 0 - no muscle activation 1 - trace muscle activation such as a twitch without achieving full range of motion 2 - muscle activation with gravity eliminated achieving full range of motion 3 - muscle activation against gravity full range of motion 4 - muscle activation against some resistance full range of motion 5 - muscle activation against examiners full resistance full range of motion
The dermatome sensibility assessment will be done by asking about how intense is the patients sensation to an ice pack put on their anterior medial or lateral aspect of the thigh in comparison to the opposite side If the could sensation is less intense than the opposite side that nerve territory will be considered blocked to the ice sensation
The potential complications related to the nerve block to be interrogated are ipsilateral lower limb weakness occurrence of fall infection signs redness purulent secretion local hyperthermia pruritus sensation burning sensation tingling sensation electrical shock sensation symptoms or signs of LAST any of the following numbness on tongue and lips diplopia tinnitus metal taste on mouth seizure
Sample size The sample size was calculated based on previous study that compared supra-inguinal FICB versus LAI in 60 patients undergoing elective THA23 They found no difference between the groups for opioid consumption on the first 24h after the surgery however the group FICB had higher occurrence of quadriceps muscle weakness on the first six hours after surgery That study can be considered as comparing a muscle weakness associated technique FICB with a technique not associated with muscle weakness LAI which found a significant difference for quadriceps weakness incidence in a sample of 60 patients Translating the same numbers for a similar study evaluating local anesthetic concentration and the occurrence of motor block motor sparing concentration versus a non-sparing concentration the investigators plan to include 30 patients per group
Study data analysis Normal distributed variables values will be presented and analyzed as mean values standard deviation SD Non-normal distributed variables values will be presented and analyzed as median and minimum and maximum values Qualitative variables will be presented as frequency of occurrence Statistical test to be performed might be t-Student Kruskal-Wallis and Chi-square Study data will be collected and managed using a password protected Microsoft Excel sheet Microsoft Corporation 2018 Statistical software will be used for analysis SPSS 130 for Windows SPSS Inc Chicago IL USA and GraphPad Prism Version 400 for Windows GraphPad Software San Diego CA USA
Objectives The primary objective will be to evaluate efficacy of LCLA-FICB in comparison to HCLA-FICB for patients undergoing primary THA in terms of pain scores and opioid consumption
The secondary objective is to assess postoperative opioid related side effects and ipsilateral quadriceps weakness between those two postoperative analgesia techniques
Hypothesis The LCLA-FICB in comparison to HCLA-FICB provides non-inferior postoperative analgesia in the first 24 hours following primary THA while at the same time preserving quadriceps muscle group strength
Methods Study type This will be a randomized controlled prospective trial blinded for patient and evaluator in patients undergoing primary THA at Sinai Health After Hospitals Ethics in Research Board approval the recruitment will begin Patients will be assessed about their eligibility for participating and after plain clear information about the study interventions they will or will not authorize their inclusion and data collection through the signature of a written consent
Perioperative management and interventions The subjects will have their surgeries booked in advance and they will be submitted to the pre anesthesia consult at the Pre-Admission Unit PAU a few days before the surgery The study proposal will be explained to the patients on that occasion and they will receive the consent form with the information about the study that they will bring home to review They will have the time between the pre anesthesia assessment and the surgery at least 24 hours to review and consent to the study
Patients will be randomized to one of the two groups using a computer-generated random numbers table The randomization will be done before the beginning of the study and will define which study number is going to be managed as intervention group LCLA-FICB or control group HCLA-FICB Each patient will receive a study number following the order of their entrance on the study and that number will be already linked for one of the two groups Closed envelopes will be prepared ahead of time and each of them will have the name of the group related to its study number Once the patient is included the research coordinator will check inside the envelope which group the patient is randomized to in order to prepare the solution for the FICB LCLA or HCLA A list with the study numbers and the randomization will be kept by the research coordinator under password protection and will be shared with other researches only after all data collection is finished The patient the research assistant the professional who performs the postoperative assessments and the professional providing anesthesia care to the patient will be blinded to which group each patient is randomized to
All patients will receive the same perioperative management Patients will initially be brought to a dedicated block room where a safety checklist will be performed by the block room team Standard Canadian Anesthesia Society monitoring will be provided Mild sedation with Midazolam 05-2mg and Fentanyl 25-150mcg might be administered for anxiolysis and analgesia After proper cleaning of the ipsilateral hip area under sterile technique and ultrasound guidance Sonosite Edge II ultrasound machine a supra-inguinal FICB will be performed21 Patients in the LCLA-FICB group will receive a block with 50 ml of Ropivacaine 0075 with epinephrine 1200000 Patients in the control group HCLA-FICB will receive a supra-inguinal FICB block with 50 ml of Ropivacaine 025 with epinephrine 1200000 concentration of local anesthetics used routinely for this PNB
After the FICB block is performed all patients will receive standard spinal anesthesia using Mepivacaine 2 x 35 ml with fentanyl 15 mcg and preservative free morphine 100 mcg All intraoperative opioids administered will be recorded In the intra-operative period each patient will receive IV Cefazolin 2-3 g Tranexamic acid 20 mgkg Dexamethasone 01 mgkg and Ondansetron 4 mg
Standard oral analgesic scheme will be prescribed to every patient Acetaminophen 650 - 1000 mg QID Celecoxib 100 - 200 mg BID Hydromorphone 1 - 2 mg PRN Q2Hs Hydromorphone 02 - 04 mg IV PRN Q1H
Outcomes Patients will be assessed at 1-2h before surgery for demographic information age weight height body mass index gender ASA functional status and baseline pain scores and average opioid consumption
After the surgery patients will be assessed in person by a research team member blinded to which group the patient was randomized to on 4 8 24 and 48 hours after the spinal anesthesia moment as following
4 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
8 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications
24 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
48 hours time point pain scores quadriceps muscle weakness sensitive dermatomes nerve block related complications opioid consumption
The primary end point of the study is the degree of muscle weakness on 4 hours after surgery Secondary outcome parameters will include the following total opioid consumption at 48 hours pain scores dermatomes sensation impairment nerve block related complicaitonsand hospital length of stay
Pain will be measured using the numerical rating scale NRS for pain 0 no pain at all 10 worst pain For the 4- and 8-hours assessments the patients will be asked to rate their lowest and highest pain scores for the last 4 and 8 hours From the rest of the moments they will be asked to rate their pain at rest and at movement from sitting position to standing up Opioid usage will be measure in oral morphine equivalent doses Quadriceps weakness will be evaluated using the Muscle Strength Grading Oxford Scale by a member of the research team22 0 - no muscle activation 1 - trace muscle activation such as a twitch without achieving full range of motion 2 - muscle activation with gravity eliminated achieving full range of motion 3 - muscle activation against gravity full range of motion 4 - muscle activation against some resistance full range of motion 5 - muscle activation against examiners full resistance full range of motion
The dermatome sensibility assessment will be done by asking about how intense is the patients sensation to an ice pack put on their anterior medial or lateral aspect of the thigh in comparison to the opposite side If the could sensation is less intense than the opposite side that nerve territory will be considered blocked to the ice sensation
The potential complications related to the nerve block to be interrogated are ipsilateral lower limb weakness occurrence of fall infection signs redness purulent secretion local hyperthermia pruritus sensation burning sensation tingling sensation electrical shock sensation symptoms or signs of LAST any of the following numbness on tongue and lips diplopia tinnitus metal taste on mouth seizure
Sample size The sample size was calculated based on previous study that compared supra-inguinal FICB versus LAI in 60 patients undergoing elective THA23 They found no difference between the groups for opioid consumption on the first 24h after the surgery however the group FICB had higher occurrence of quadriceps muscle weakness on the first six hours after surgery That study can be considered as comparing a muscle weakness associated technique FICB with a technique not associated with muscle weakness LAI which found a significant difference for quadriceps weakness incidence in a sample of 60 patients Translating the same numbers for a similar study evaluating local anesthetic concentration and the occurrence of motor block motor sparing concentration versus a non-sparing concentration the investigators plan to include 30 patients per group
Study data analysis Normal distributed variables values will be presented and analyzed as mean values standard deviation SD Non-normal distributed variables values will be presented and analyzed as median and minimum and maximum values Qualitative variables will be presented as frequency of occurrence Statistical test to be performed might be t-Student Kruskal-Wallis and Chi-square Study data will be collected and managed using a password protected Microsoft Excel sheet Microsoft Corporation 2018 Statistical software will be used for analysis SPSS 130 for Windows SPSS Inc Chicago IL USA and GraphPad Prism Version 400 for Windows GraphPad Software San Diego CA USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None