Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436694
Status:
UNKNOWN
Last Update Posted:
2015-11-26
First Post:
2015-04-01
Brief Title:
Nerve Blocks With Dexamethasone and Local Anaesthetic to Improve Postoperative Analgesia
Sponsor:
Centro Hospitalar do Porto
Organization:
Centro Hospitalar do Porto
Study Overview
Official Title:
Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
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:
Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty Primary aim Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores assessed by VAS
Outcome measures Mean pain scores in both groups Secondary aims Evaluate opioid consumption in the postoperative period 8- 12h 24h 48h and assess incidence of side effects and complications numbness paraesthesias weakness site infection haematoma and falls
Outcome measures Mean pain scores in both groups Secondary aims Evaluate opioid consumption in the postoperative period 8- 12h 24h 48h and assess incidence of side effects and complications numbness paraesthesias weakness site infection haematoma and falls
Detailed Description:
All blocks are performed using nerve stimulation technique For the SSFNB the paravascular approach will be used to identify the femoral nerve15 A positive location is considered when quadriceps contraction patellar elevation is elicited with a current of 04 mA or less and 30mL of ropivacaine 0375 with or without 4mg of dexamethasone are injected according to the randomization
For the SSSNB the anterior approach will be chosen16 The common peroneal or the tibial nerves are identified respectively by dorsiflexion or plantar flexion of the foot with a current of 04 mA or less Depending on the allocated group 20mL of ropivacaine 02 with or without 4mg of dexamethasone are then injected Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block
The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure
Patients will then have an intravenous induction to general anesthesia being the maintenance assured with either Desflurane or Sevoflurane Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg Total doses of intraoperative analgesics are recorded
Before surgery all patients will be explained how to use the PCA which is connected after arrival to the post-anesthesia unit PACU The PCA is programmed for 1mg bolus as required by the patient with a lockout period of 7 minutes In what concerns the remaining post-operative analgesia both groups are prescribed paracetamol 1000mg q8h diclofenac 50mg q12h and as rescue strategy tramadol 100mg q6h
The demographic data as well as the information of the anesthetic form is recorded in an excel table After surgery at 8-12h 24h and 48h -2h pain is evaluated using a standard 100mm VAS Consumption of morphine and other rescue analgesia is recorded in the same time periods as well as the complications and side-effects previously determined
The primary outcome is pain assessed by VAS 1-100mm - continuous variable measured ate 8-12h 24h and 48h Difference in mean values for both groups will be measured Morphine consumption is measured in milligrams and the mean consumption of both groups is analysed Side-effects and complications will be reported and their incidence calculated
For the SSSNB the anterior approach will be chosen16 The common peroneal or the tibial nerves are identified respectively by dorsiflexion or plantar flexion of the foot with a current of 04 mA or less Depending on the allocated group 20mL of ropivacaine 02 with or without 4mg of dexamethasone are then injected Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block
The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure
Patients will then have an intravenous induction to general anesthesia being the maintenance assured with either Desflurane or Sevoflurane Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg Total doses of intraoperative analgesics are recorded
Before surgery all patients will be explained how to use the PCA which is connected after arrival to the post-anesthesia unit PACU The PCA is programmed for 1mg bolus as required by the patient with a lockout period of 7 minutes In what concerns the remaining post-operative analgesia both groups are prescribed paracetamol 1000mg q8h diclofenac 50mg q12h and as rescue strategy tramadol 100mg q6h
The demographic data as well as the information of the anesthetic form is recorded in an excel table After surgery at 8-12h 24h and 48h -2h pain is evaluated using a standard 100mm VAS Consumption of morphine and other rescue analgesia is recorded in the same time periods as well as the complications and side-effects previously determined
The primary outcome is pain assessed by VAS 1-100mm - continuous variable measured ate 8-12h 24h and 48h Difference in mean values for both groups will be measured Morphine consumption is measured in milligrams and the mean consumption of both groups is analysed Side-effects and complications will be reported and their incidence calculated
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