Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317870
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-04
Brief Title:
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty
Sponsor:
Centre Hospitalier Universitaire Vaudois
Organization:
Centre Hospitalier Universitaire Vaudois
Study Overview
Official Title:
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty a Double Blind Non-inferiority Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PENGIT
Brief Summary:
The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block PENG with intrathecal morphine in patients scheduled for total hip replacement surgery The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain
Participants will be randomised into two groups Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic isobaric bupivacaine alone and a PENG block Patients assigned to the intrathecal morphine ITM group will receive spinal anaesthesia with a mixture of local anaesthetic isobaric bupivacaine and morphine 100 mcg and a sham PENG block to ensure patient blinding
Participants will be randomised into two groups Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic isobaric bupivacaine alone and a PENG block Patients assigned to the intrathecal morphine ITM group will receive spinal anaesthesia with a mixture of local anaesthetic isobaric bupivacaine and morphine 100 mcg and a sham PENG block to ensure patient blinding
Detailed Description:
The aim of this double-blind non-inferiority study is to compare the analgesic effect of a PENG block with intrathecal morphine in patients scheduled for total hip arthroplasty Postoperative morphine consumption and pain scores morphine-related adverse effects and functional parameters will be compared between two groups
The investigators believe that PENG block provides postoperative analgesia equivalent to intrathecal morphine The research team plans to enrol 80 patients and randomise them to two groups - pericapsular nerve block PENG or intrathecal morphine ITM After written informed consent patients will be allocated to one of the two groups according to a computer-generated randomisation list The PENG group will receive central spinal anaesthesia with 125 mg isobaric bupivacaine followed by a PENG block with 20 cc of 075 ropivacaine ITM groups will receive central spinal anaesthesia with 125 mg isobaric bupivacaine and 100 mcg morphine followed by a sham PENG block
During the surgery 015 mgkg of dexamethasone iv 1g acetaminophen iv 30mg ketorolac iv and 40mgkg magnesium iv will be administered for post operative analgesia
In the post-operative care unit pain management will be provided with as needed with 2mg of IV morphine at ten minute intervals for pain scores 3 Once spinal motor block has ceded the patients will be transferred to the surgical ward with a morphine patient controlled analgesia PCA pump The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours Basal analgesia will be provided with paracetamol 1g6h and ibuprofen 400mg8h Ondansetron 4mg IV will be provided in case of nausea or vomiting A research assistant will conduct post operative visits at 2h 1 day and 2 days post-operatively to record research data Functional testing will be performed at day 1 and 2 by physiotherapy personnel
The investigators believe that PENG block provides postoperative analgesia equivalent to intrathecal morphine The research team plans to enrol 80 patients and randomise them to two groups - pericapsular nerve block PENG or intrathecal morphine ITM After written informed consent patients will be allocated to one of the two groups according to a computer-generated randomisation list The PENG group will receive central spinal anaesthesia with 125 mg isobaric bupivacaine followed by a PENG block with 20 cc of 075 ropivacaine ITM groups will receive central spinal anaesthesia with 125 mg isobaric bupivacaine and 100 mcg morphine followed by a sham PENG block
During the surgery 015 mgkg of dexamethasone iv 1g acetaminophen iv 30mg ketorolac iv and 40mgkg magnesium iv will be administered for post operative analgesia
In the post-operative care unit pain management will be provided with as needed with 2mg of IV morphine at ten minute intervals for pain scores 3 Once spinal motor block has ceded the patients will be transferred to the surgical ward with a morphine patient controlled analgesia PCA pump The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours Basal analgesia will be provided with paracetamol 1g6h and ibuprofen 400mg8h Ondansetron 4mg IV will be provided in case of nausea or vomiting A research assistant will conduct post operative visits at 2h 1 day and 2 days post-operatively to record research data Functional testing will be performed at day 1 and 2 by physiotherapy personnel
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