Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539910
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Modified TIPS Block for Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Modified Triple Injection Peri-Sartorius TIPS Block for Postoperative Analgesia After Total Knee Arthroplasty TKA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty TKA
Detailed Description:
We hypothesise that LA injection at a plane deep to adductor longus muscle at the level of femoral triangle may block the 2 divisions of the ON and improve analgesia following TKA Moreover the medial to lateral needle trajectory may avoid NVM injury
Aim of the work The primary aim of this study is to determine if addition of LA injection underneath the ALM targeting ON divisions to tri-injection perisartorius TIPS block may decrease the postoperative opioid rescue analgesic requirements after TKA
The secondary aim of this study is to investigate the effect of addition of LA injection under the ALM to TIPS block on the resting and dynamic VAS scores during the 1st 24 h postoperative period The secondary aims include the time to the 1st request of rescue analgesia the motor power of the operated limb as well as any complication related to the block technique
Methods After obtaining approval from Alexandria university ethics committee this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists ASA physical status I-III 90 patients scheduled for unilateral TKA Based on a pilot study a total sample size of 90 participants - 45 patients in TIPS group and 45 patients in mTIPS group - is needed to achieve 80 power and to detect difference of 06 mg in the mean of morphine consumption between the two groups with group standard deviations of 1 Using t test a two-sided two-sample t-test at a significance level of 05 Sample size was calculated using NCSS 2004 and PASS 2000 program Informed written consent will be signed by all patients The visual analogue scale VAS score interpretation and the use of patient controlled analgesia PCA device will be explained to all participants The exclusion criteria will include BMI 35 kgm2 pre-existing neurological deficit any disability of the non-operated limb preventing fair mobilization known contraindications to peripheral nerve block coagulopathy or infection at the site of injection or chronic opioid usersabusers Patients will be randomised into 2 groups using a closed envelope technique
Group TIPS patients will receive distal FTB through conventional lateral to medial approach in addition to a supra-sartorial plane injection
Group MTIPS patients will receive ultrasound guided single puncture triple injections through medial to lateral approach LA will be injected at the distal FT lateral to the superficial femoral artery FA deep to adductor longus muscle ALM and at the supra-sartorial plane
Both groups will receive distal adductor canal block via another needle puncture
All blocks will be performed after induction of general anaesthesia GA Upon arrival to the operating room OR a multichannel monitor will be attached to patients followed by the administration of 2 mg midazolam IV after securing an IV cannula Controlled GA via a laryngeal mask airway LMA will be done to all patients
Both groups will receive a mixture of 025 bupivacaine and 8 mg dexamethasone Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal The total volume of LA will be determined according to group selection
Group TIPS Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery Then the needle will be redirected to perform the suprasartorial plane injection Total volume of LA will be 40 mL
Group MTIPS Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery Then the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle AMM Again the needle will be redirected to perform the suprasartorial plane injection Total volume of LA will be 50 mL
Postoperatively multimodal analgesia regimen will be continued in the form of paracetamol 1 g 8 hours and ketorolac 30 mg 8 hours intravenously for 24 hours Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 05 mgml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes The time to the 1st demand dose of rescue analgesia will be recorded Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 h follow up period Total postoperative morphine requirements will be measured during the 24 h postoperative follow up period Postoperative functional outcome will be assessed using the Timed Up and Go TUG test and the 30-second Chair Stand Test 30s-CST in the evening of the day of surgery
Aim of the work The primary aim of this study is to determine if addition of LA injection underneath the ALM targeting ON divisions to tri-injection perisartorius TIPS block may decrease the postoperative opioid rescue analgesic requirements after TKA
The secondary aim of this study is to investigate the effect of addition of LA injection under the ALM to TIPS block on the resting and dynamic VAS scores during the 1st 24 h postoperative period The secondary aims include the time to the 1st request of rescue analgesia the motor power of the operated limb as well as any complication related to the block technique
Methods After obtaining approval from Alexandria university ethics committee this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists ASA physical status I-III 90 patients scheduled for unilateral TKA Based on a pilot study a total sample size of 90 participants - 45 patients in TIPS group and 45 patients in mTIPS group - is needed to achieve 80 power and to detect difference of 06 mg in the mean of morphine consumption between the two groups with group standard deviations of 1 Using t test a two-sided two-sample t-test at a significance level of 05 Sample size was calculated using NCSS 2004 and PASS 2000 program Informed written consent will be signed by all patients The visual analogue scale VAS score interpretation and the use of patient controlled analgesia PCA device will be explained to all participants The exclusion criteria will include BMI 35 kgm2 pre-existing neurological deficit any disability of the non-operated limb preventing fair mobilization known contraindications to peripheral nerve block coagulopathy or infection at the site of injection or chronic opioid usersabusers Patients will be randomised into 2 groups using a closed envelope technique
Group TIPS patients will receive distal FTB through conventional lateral to medial approach in addition to a supra-sartorial plane injection
Group MTIPS patients will receive ultrasound guided single puncture triple injections through medial to lateral approach LA will be injected at the distal FT lateral to the superficial femoral artery FA deep to adductor longus muscle ALM and at the supra-sartorial plane
Both groups will receive distal adductor canal block via another needle puncture
All blocks will be performed after induction of general anaesthesia GA Upon arrival to the operating room OR a multichannel monitor will be attached to patients followed by the administration of 2 mg midazolam IV after securing an IV cannula Controlled GA via a laryngeal mask airway LMA will be done to all patients
Both groups will receive a mixture of 025 bupivacaine and 8 mg dexamethasone Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal The total volume of LA will be determined according to group selection
Group TIPS Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery Then the needle will be redirected to perform the suprasartorial plane injection Total volume of LA will be 40 mL
Group MTIPS Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery Then the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle AMM Again the needle will be redirected to perform the suprasartorial plane injection Total volume of LA will be 50 mL
Postoperatively multimodal analgesia regimen will be continued in the form of paracetamol 1 g 8 hours and ketorolac 30 mg 8 hours intravenously for 24 hours Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 05 mgml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes The time to the 1st demand dose of rescue analgesia will be recorded Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 h follow up period Total postoperative morphine requirements will be measured during the 24 h postoperative follow up period Postoperative functional outcome will be assessed using the Timed Up and Go TUG test and the 30-second Chair Stand Test 30s-CST in the evening of the day of surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None