Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898581
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-06-02
Brief Title:
PENG Block vs Intraoperative Local Anesthetic Infiltration for Total Hip Arthroplasty
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Ultrasound-guided Pericapsular Nerve Group PENG Block vs Intraoperative Local Anesthetic Infiltration ILAI for Total Hip Arthroplasty THA a Single Center Non-inferiority Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Currently the analgesic standard of care for patients undergoing total hip arthroplasty THA at our centre is intraoperative infiltration with a solution of local anesthetic morphine opioid and ketorolac nonsteroidal anti-inflammatory drug - NSAID If a patient has a contraindication for the use of an opioid or NSAIDs this infiltration is performed with a plain local anesthetic No blocks numbing of certain nerves to prevent pain from occurring in that area are performed for postoperative pain in these patients The pericapsular nerve group PENG block is a recently described technique with limited data in the literature that has assessed the benefits of using this nerve block for THA procedures The purpose of this study is to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration ILAI with an associated cost benefit for patients undergoing THA
Detailed Description:
Traditionally the most common ultrasound-guided nerve blocks utilized for hip analgesia during THA are the Femoral Nerve Block and the Fascia Iliaca Block Despite the analgesia component of both techniques they can cause quadriceps weakness1-2 which is an unwanted side effect for this patient population as it interferes with surgical recovery physical therapy and increases the risk of fall For these reasons these types of blocks are not performed for patients undergoing THA at our center London Health Science Centre
In 2018 a cadaveric study performed by Short et al demonstrated that the hip capsule is innervated by sensory branches of the Femoral Nerve and Accessory Obturator Nerves3 An ultrasound-guided technique for the blockade of the articular branches of the hip was first described by Giron-Arango et al4 The major benefit of using this approach is the possible motor-sparing effect capable of maintaining the quadriceps muscle force as the technique aims only at sensory articular branches
The current standard care for postoperative analgesia for THA is intraoperative infiltration with a solution containing ropivacaine 025 local anesthetic morphine opioid and ketorolac NSAID Patients with any contra-indication for the administration of opioids or nonsteroidal anti-inflammatories receive intraoperative infiltration with plain local anesthetic
The efficacy of ILAI for THA remains inconclusive While some studies validated the benefit of this technique5-9 others were not able to confirm improvements in pain control10-15 As it is a simple technique based on the injection of analgesic solution in the tissue surrounding the surgical field it has become a popular intervention
Similarly the analgesic efficacy of the PENG block for THA remains unclear As the PENG block involves sensory articular nerves of the anterior hip capsule the benefit for the patients lies in the possibility of having a good analgesic response along with no motor leg weakness This will improve patient care during the postoperative period with early mobilization and adequate pain control There is limited information in the literature available regarding the use of the PENG block as part of the postoperative analgesia plan for THA Thus we have identified a need to conduct a trial that aims to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration ILAI
In 2020 a retrospective case series by Kukreja et al16 evaluated twelve patients that underwent total hip arthroplasty six primaries six revisions This study showed a decrease in opioid consumption in the primary THA group In this group two patients had spinal anesthesia as the primary anesthesia technique while four received general anesthetic Hence the results of this study have suggested that the PENG block may be useful for postoperative analgesia in this procedure
Following this case report series Aliste et al17 conducted a randomized trial comparing the ultrasound-guided PENG block with the ultrasound-guided suprainguinal fascia iliaca block with the purpose of evaluating the postoperative incidence of quadriceps motor block as the primary outcome In this study the PENG block resulted in a lower incidence of quadriceps motor block compared with the suprainguinal fascia iliaca block
In addition two randomized clinical trials were conducted in 2022 involving the addition of the ultrasound-guided PENG block in the analgesic plan for patients that underwent THA demonstrating benefits Both of these studies demonstrated benefits of incorporating the PENG block into the analgesic care plan for this patient population First Lin et al18 conducted a randomized clinical trial in which patients received either a PENG block or a sham block in addition to spinal anesthesia and ILAI 100ml of ropivacaine 01 with 1mg of epinephrine In this study the patients that received the PENG block had less postoperative pain with preservation of quadriceps muscle strength
Second Zheng et al19 performed a similar randomized trial in which patients undergoing THA were randomized to the intervention group that received the PENG block or to the placebo group in which a PENG block was simulated with an injection of 20ml of normal saline solution All patients had general anesthesia as the main anesthetic plan and received an ILAI with 20ml of ropivacaine 05 by the end of the procedure The study showed that the addition of a PENG block provided a limited advantage to postoperative analgesia in the Post-Anesthesia Care Unit PACU and lower intraoperative opioid consumption
At this point in our understanding no further clinical data is available comparing the analgesic efficacy of PENG block with ILAI Further clinical trials are needed to test the efficacy of PENG blocks
Following consent patients will be randomized to one of two study groups on a 11 basis
Group 1 patients will receive ultrasound-guided PENG block PENG group with local anesthetics 20 ml of 05 ropivacaine before administration of spinal anesthesia
Group 2 patients will receive a sham PENG block performed with 20ml of normal saline solution before spinal anesthesia After patients will receive ILAI performed by the operating surgeon with a plain solution of ropivacaine 025 60ml
The block group PENG group will be administered a single dose of ultrasound-guided PENG block with 20ml of ropivacaine 05 drawn up by an anesthesiologist in the BR before the spinal anesthesia All patients will be offered Midazolam 1-2 mg IV before the start of the interventions In the control group a sham PENG block with 20ml of normal saline will be performed before spinal anesthesia After ILAI will be performed by the operating surgeon with a plain solution of ropivacaine 025 60ml In both groups the anesthesiologist will be blinded to perform the PENG and Sham block Next spinal anesthesia will be performed with bupivacaine 05 10-15mg intrathecally The spinal anesthesia will be tested for sensory block to cold using an alcoholic chlorhexidine pad and for motor block by asking the patient to move either leg The timing of the completion of the spinal anesthesia will be marked and it will be considered time zero Next the patient will be moved to the main OR for surgery Intraoperative sedation will be at the discretion of the OR anesthesiologist If spinal anesthesia fails the patient will receive general anesthetic in the operating room This patient will however remain in the study group as intention to treat
A blinded data colletor will record all outcomes NRS pain score PACU length muscle strength and intraoperative opioid consumption The timing of the completion of the spinal anesthesia will be considered time zero Six hours after the completion of the neuraxial procedure the patient will be approached by the blinded data collector for the NRS pain score primary outcome At 9 12 and 24 hours after the end of the spinal anesthesia the patient will be approached again for the NRS pain score Pain score evaluation will be recorded at rest on passive movement and on active movement of the operated hip joint Also the quadriceps muscle strength will be evaluated by the capacity of the patient to perform knee extension at 6 9 12 and 24 hours postoperatively Data will be collected for the patients opioid consumption in the 24 hours after the spinal anesthesia was completed Pain assessment and muscle strength will be evaluated using the following scales
Pain assessment A Likert-like numerical rating scale NRS will be used for pain assessment 0 no pain 1-3 mild pain 4-6 moderate pain interfering with activity and 7-10 severe disabling pain
Muscle strength The quadriceps muscle function will be evaluated Strength testing of the quadriceps will include the resistance of knee extension and hip flexion Commonly used muscle testing grading will be used
Grade 5 Full range of motion against gravity with maximal resistance Grade 4 Full range of motion against gravity moderate resistance Grade 3 Full range of motion against gravity Grade 2 Full range of motion gravity eliminated Grade 1 Visible or palpable contraction without motion Grade 0 No visible or palpable contraction
All patients will be offered oral opioids on an as-needed basis The total amount of opioids administered to the patient in the 24 hours after the neuraxial procedure will be evaluated
In 2018 a cadaveric study performed by Short et al demonstrated that the hip capsule is innervated by sensory branches of the Femoral Nerve and Accessory Obturator Nerves3 An ultrasound-guided technique for the blockade of the articular branches of the hip was first described by Giron-Arango et al4 The major benefit of using this approach is the possible motor-sparing effect capable of maintaining the quadriceps muscle force as the technique aims only at sensory articular branches
The current standard care for postoperative analgesia for THA is intraoperative infiltration with a solution containing ropivacaine 025 local anesthetic morphine opioid and ketorolac NSAID Patients with any contra-indication for the administration of opioids or nonsteroidal anti-inflammatories receive intraoperative infiltration with plain local anesthetic
The efficacy of ILAI for THA remains inconclusive While some studies validated the benefit of this technique5-9 others were not able to confirm improvements in pain control10-15 As it is a simple technique based on the injection of analgesic solution in the tissue surrounding the surgical field it has become a popular intervention
Similarly the analgesic efficacy of the PENG block for THA remains unclear As the PENG block involves sensory articular nerves of the anterior hip capsule the benefit for the patients lies in the possibility of having a good analgesic response along with no motor leg weakness This will improve patient care during the postoperative period with early mobilization and adequate pain control There is limited information in the literature available regarding the use of the PENG block as part of the postoperative analgesia plan for THA Thus we have identified a need to conduct a trial that aims to investigate if the ultrasound-guided PENG block can provide non-inferior postoperative analgesia compared to local intraoperative anesthetic infiltration ILAI
In 2020 a retrospective case series by Kukreja et al16 evaluated twelve patients that underwent total hip arthroplasty six primaries six revisions This study showed a decrease in opioid consumption in the primary THA group In this group two patients had spinal anesthesia as the primary anesthesia technique while four received general anesthetic Hence the results of this study have suggested that the PENG block may be useful for postoperative analgesia in this procedure
Following this case report series Aliste et al17 conducted a randomized trial comparing the ultrasound-guided PENG block with the ultrasound-guided suprainguinal fascia iliaca block with the purpose of evaluating the postoperative incidence of quadriceps motor block as the primary outcome In this study the PENG block resulted in a lower incidence of quadriceps motor block compared with the suprainguinal fascia iliaca block
In addition two randomized clinical trials were conducted in 2022 involving the addition of the ultrasound-guided PENG block in the analgesic plan for patients that underwent THA demonstrating benefits Both of these studies demonstrated benefits of incorporating the PENG block into the analgesic care plan for this patient population First Lin et al18 conducted a randomized clinical trial in which patients received either a PENG block or a sham block in addition to spinal anesthesia and ILAI 100ml of ropivacaine 01 with 1mg of epinephrine In this study the patients that received the PENG block had less postoperative pain with preservation of quadriceps muscle strength
Second Zheng et al19 performed a similar randomized trial in which patients undergoing THA were randomized to the intervention group that received the PENG block or to the placebo group in which a PENG block was simulated with an injection of 20ml of normal saline solution All patients had general anesthesia as the main anesthetic plan and received an ILAI with 20ml of ropivacaine 05 by the end of the procedure The study showed that the addition of a PENG block provided a limited advantage to postoperative analgesia in the Post-Anesthesia Care Unit PACU and lower intraoperative opioid consumption
At this point in our understanding no further clinical data is available comparing the analgesic efficacy of PENG block with ILAI Further clinical trials are needed to test the efficacy of PENG blocks
Following consent patients will be randomized to one of two study groups on a 11 basis
Group 1 patients will receive ultrasound-guided PENG block PENG group with local anesthetics 20 ml of 05 ropivacaine before administration of spinal anesthesia
Group 2 patients will receive a sham PENG block performed with 20ml of normal saline solution before spinal anesthesia After patients will receive ILAI performed by the operating surgeon with a plain solution of ropivacaine 025 60ml
The block group PENG group will be administered a single dose of ultrasound-guided PENG block with 20ml of ropivacaine 05 drawn up by an anesthesiologist in the BR before the spinal anesthesia All patients will be offered Midazolam 1-2 mg IV before the start of the interventions In the control group a sham PENG block with 20ml of normal saline will be performed before spinal anesthesia After ILAI will be performed by the operating surgeon with a plain solution of ropivacaine 025 60ml In both groups the anesthesiologist will be blinded to perform the PENG and Sham block Next spinal anesthesia will be performed with bupivacaine 05 10-15mg intrathecally The spinal anesthesia will be tested for sensory block to cold using an alcoholic chlorhexidine pad and for motor block by asking the patient to move either leg The timing of the completion of the spinal anesthesia will be marked and it will be considered time zero Next the patient will be moved to the main OR for surgery Intraoperative sedation will be at the discretion of the OR anesthesiologist If spinal anesthesia fails the patient will receive general anesthetic in the operating room This patient will however remain in the study group as intention to treat
A blinded data colletor will record all outcomes NRS pain score PACU length muscle strength and intraoperative opioid consumption The timing of the completion of the spinal anesthesia will be considered time zero Six hours after the completion of the neuraxial procedure the patient will be approached by the blinded data collector for the NRS pain score primary outcome At 9 12 and 24 hours after the end of the spinal anesthesia the patient will be approached again for the NRS pain score Pain score evaluation will be recorded at rest on passive movement and on active movement of the operated hip joint Also the quadriceps muscle strength will be evaluated by the capacity of the patient to perform knee extension at 6 9 12 and 24 hours postoperatively Data will be collected for the patients opioid consumption in the 24 hours after the spinal anesthesia was completed Pain assessment and muscle strength will be evaluated using the following scales
Pain assessment A Likert-like numerical rating scale NRS will be used for pain assessment 0 no pain 1-3 mild pain 4-6 moderate pain interfering with activity and 7-10 severe disabling pain
Muscle strength The quadriceps muscle function will be evaluated Strength testing of the quadriceps will include the resistance of knee extension and hip flexion Commonly used muscle testing grading will be used
Grade 5 Full range of motion against gravity with maximal resistance Grade 4 Full range of motion against gravity moderate resistance Grade 3 Full range of motion against gravity Grade 2 Full range of motion gravity eliminated Grade 1 Visible or palpable contraction without motion Grade 0 No visible or palpable contraction
All patients will be offered oral opioids on an as-needed basis The total amount of opioids administered to the patient in the 24 hours after the neuraxial procedure will be evaluated
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