Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621849
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Effect of Unilateral Erector Spinae Plane Block Versus Intrathecal Morphine on Early Mobilization After Hip Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Unilateral Erector Spinae Plane Block Versus Intrathecal Morphine on Early Mobilization After Total Hip Replacement Under Spinal Anesthesia in Cairo University Hospitals a Prospective Randomized Clinical Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
Preoperative assessment Patients who fulfill inclusion criteria will be evaluated by medical history physical examination and clinical laboratory tests which are a complete blood picture CBC kidney function tests liver function tests international normalized ratioINR prothrombin timePT and chest X-Ray An electrocardiograph ECG will be done for patients above 40 years old Patients will be prepared by 8 hours of preoperative fasting receiving a tablet of Omeprazole 20 mg and Alprazolam 05 mg at bedtime the day before surgery
All patients will be educated about the standard Numerical Rating Scale NRS for pain score of 0-10 0 no pain 10 the most severe pain during preanesthetic evaluation visit
In our study 70 patients will be randomly divided into two equal groups with 35 pt in each Spinal anesthesia will be performed at L3-L4 with 35 ml of hyperbaric bupivacaine 05 and 025 ml normal saline only for the E group or 01 mg morphine in 025 ml normal saline for the M group 9
Group E will receive ESPB on the ipsilateral side of the surgery then 35 ml of bupivacaine 05 and 025 ml of normal saline intrathecal
Group M will receive 5 ml of subcutaneous lidocaine 1 then 35 ml of bupivacaine 05 and 01 mg of morphine in 025 ml of normal saline intrathecal
All patients will be educated about the standard Numerical Rating Scale NRS for pain score of 0-10 0 no pain 10 the most severe pain during preanesthetic evaluation visit
In our study 70 patients will be randomly divided into two equal groups with 35 pt in each Spinal anesthesia will be performed at L3-L4 with 35 ml of hyperbaric bupivacaine 05 and 025 ml normal saline only for the E group or 01 mg morphine in 025 ml normal saline for the M group 9
Group E will receive ESPB on the ipsilateral side of the surgery then 35 ml of bupivacaine 05 and 025 ml of normal saline intrathecal
Group M will receive 5 ml of subcutaneous lidocaine 1 then 35 ml of bupivacaine 05 and 01 mg of morphine in 025 ml of normal saline intrathecal
Detailed Description:
Preoperative assessment Patients who fulfill inclusion criteria will be evaluated by medical history physical examination and clinical laboratory tests which are a complete blood picture CBC kidney function tests liver function tests international normalized ratioINR prothrombin timePT and chest X-Ray An electrocardiograph ECG will be done for patients above 40 years old Patients will be prepared by 8 hours of preoperative fasting receiving a tablet of Omeprazole 20 mg and Alprazolam 05 mg at bedtime the day before surgery
All patients will be educated about the standard Numerical Rating Scale NRS for pain score of 0-10 0 no pain 10 the most severe pain during preanesthetic evaluation visit
In our study 70 patients will be randomly divided into two equal groups with 35 pt in each Spinal anesthesia will be performed at L3-L4 with 35 ml of hyperbaric bupivacaine 05 and 025 ml normal saline only for the E group or 01 mg morphine in 025 ml normal saline for the M group 9
Group E will receive ESPB on the ipsilateral side of the surgery then 35 ml of bupivacaine 05 and 025 ml of normal saline intrathecal
Group M will receive 5 ml of subcutaneous lidocaine 1 then 35 ml of bupivacaine 05 and 01 mg of morphine in 025 ml of normal saline intrathecal
Study procedure and anaesthetic technique
On the arrival of patients in the operating room an 18 gauge intravenous cannula will be inserted and normal saline 10 mlkg will be infused as a preload The patients will be connected to a monitor to record heart rate HR non-invasive measurement of systolic blood pressure SBP diastolic blood pressure DBP main blood pressure continuous electrocardiogram monitoring ECG and oxygen saturation SpO2 Base line reading will be recorded
All backup measures and equipment for general anesthesia will be ready for urgent use or rescue general anesthesia could be required
In the ESPB group an ultrasound-guided ESPB will be performed on the ipsilateral side of the surgery while the patient is in lateral position using a linear 6-13 MHz ultrasound probe SONOSITE Fujifilm S-Nerve USA vertical parallel and 3-5 cm from the midline 10 Moving cephalic from the sacrum we will identify the L5 L4 and L3 transverse processes and erector spinae muscles posteriorly A 21 G and 70mm length needle SonoPlex Pajunk Medizintechnologie Germany will be directed in-plane and the needle tip will be positioned anterior to the erector spinae muscle at the corner of the transverse process After the initial saline injection dissection of the plane will be observed by injecting a total volume of 20 ml composed of 10 micrograms dexmedetomidine in 2ml of normal saline and 18 ml of bupivacaine 025 which is far from the toxic dose 10 Correct placement is defined as the spread of local anesthetic cranially and caudally from the injection point dissecting the plane between the transverse processes and erector spinae muscles
In the intrathecal morphine group patients will be injected with 5 ml of lidocaine subcutaneously as a local anesthetic before spinal anesthesia but using the same technique of ESPB regarding position and ultrasound guidance to ensure complete blinding of the patients
Patients from both groups will then receive spinal anaesthesia intrathecal 35 ml hyperbaric bupivacaine 05 and 025 ml normal saline for the E group or 01 mg morphine in 025 ml normal saline for the M group will be administered using a 25-G spinal needle inserted into the L3-L4 space with the patient in the sitting position with complete sterilization Then patients from both groups will be allowed to be in the supine position Sensory block will be assessed using a pin prick every 2 minutes while the patient is in the supine position until the proper level will be reached T10 dermatome and the Bromage scale will be measured to reach bromage 3 before surgery 11 Any decrease in heart rate below 60min will be treated with intravenous atropine 001 mgkg and any decrease in mean arterial pressure below 20 of the basal reading will be treated by fluid bolus and 5 mg intravenous increments of ephedrine
Failure of ESPB technique Technique failure will be defined as if the correct spread of local anesthetic cranially and caudally from the injection point dissecting the plane between the transverse processes and erector spinae muscles is not immediately visualized 10 Those patients were not included in our study and will be replaced by other patients
Failure of spinal anesthesia Technique failure will be defined as if the T10 sensory level andor Bromage 3 scale are not reached after 20 min of spinal injection 11 So rescue general anesthesia will be initiated those patients not included in our study will be replaced by others
For both groups oral paracetamol 1 gm6 hours and sustained-release diclofenac 75 mg12 hours will be administered postoperatively regularly until hospital discharge
IF any patient enrolled in our study complains of a pain score 3 with regard to NPS in spite of the previously mentioned protocol for pain management a rescue of 007 mgkg IV morphine sulphate will be administrated then NPS will be reassessed 15 minutes later if it is still 3 a rescue 005 mgkg IV morphine sulphate will be administered which can be repeated any time postoperatively until NRS is 3 or less provided that total morphine consumption does not exceed 02 mgkg4 hours 12
All patients will be educated about the standard Numerical Rating Scale NRS for pain score of 0-10 0 no pain 10 the most severe pain during preanesthetic evaluation visit
In our study 70 patients will be randomly divided into two equal groups with 35 pt in each Spinal anesthesia will be performed at L3-L4 with 35 ml of hyperbaric bupivacaine 05 and 025 ml normal saline only for the E group or 01 mg morphine in 025 ml normal saline for the M group 9
Group E will receive ESPB on the ipsilateral side of the surgery then 35 ml of bupivacaine 05 and 025 ml of normal saline intrathecal
Group M will receive 5 ml of subcutaneous lidocaine 1 then 35 ml of bupivacaine 05 and 01 mg of morphine in 025 ml of normal saline intrathecal
Study procedure and anaesthetic technique
On the arrival of patients in the operating room an 18 gauge intravenous cannula will be inserted and normal saline 10 mlkg will be infused as a preload The patients will be connected to a monitor to record heart rate HR non-invasive measurement of systolic blood pressure SBP diastolic blood pressure DBP main blood pressure continuous electrocardiogram monitoring ECG and oxygen saturation SpO2 Base line reading will be recorded
All backup measures and equipment for general anesthesia will be ready for urgent use or rescue general anesthesia could be required
In the ESPB group an ultrasound-guided ESPB will be performed on the ipsilateral side of the surgery while the patient is in lateral position using a linear 6-13 MHz ultrasound probe SONOSITE Fujifilm S-Nerve USA vertical parallel and 3-5 cm from the midline 10 Moving cephalic from the sacrum we will identify the L5 L4 and L3 transverse processes and erector spinae muscles posteriorly A 21 G and 70mm length needle SonoPlex Pajunk Medizintechnologie Germany will be directed in-plane and the needle tip will be positioned anterior to the erector spinae muscle at the corner of the transverse process After the initial saline injection dissection of the plane will be observed by injecting a total volume of 20 ml composed of 10 micrograms dexmedetomidine in 2ml of normal saline and 18 ml of bupivacaine 025 which is far from the toxic dose 10 Correct placement is defined as the spread of local anesthetic cranially and caudally from the injection point dissecting the plane between the transverse processes and erector spinae muscles
In the intrathecal morphine group patients will be injected with 5 ml of lidocaine subcutaneously as a local anesthetic before spinal anesthesia but using the same technique of ESPB regarding position and ultrasound guidance to ensure complete blinding of the patients
Patients from both groups will then receive spinal anaesthesia intrathecal 35 ml hyperbaric bupivacaine 05 and 025 ml normal saline for the E group or 01 mg morphine in 025 ml normal saline for the M group will be administered using a 25-G spinal needle inserted into the L3-L4 space with the patient in the sitting position with complete sterilization Then patients from both groups will be allowed to be in the supine position Sensory block will be assessed using a pin prick every 2 minutes while the patient is in the supine position until the proper level will be reached T10 dermatome and the Bromage scale will be measured to reach bromage 3 before surgery 11 Any decrease in heart rate below 60min will be treated with intravenous atropine 001 mgkg and any decrease in mean arterial pressure below 20 of the basal reading will be treated by fluid bolus and 5 mg intravenous increments of ephedrine
Failure of ESPB technique Technique failure will be defined as if the correct spread of local anesthetic cranially and caudally from the injection point dissecting the plane between the transverse processes and erector spinae muscles is not immediately visualized 10 Those patients were not included in our study and will be replaced by other patients
Failure of spinal anesthesia Technique failure will be defined as if the T10 sensory level andor Bromage 3 scale are not reached after 20 min of spinal injection 11 So rescue general anesthesia will be initiated those patients not included in our study will be replaced by others
For both groups oral paracetamol 1 gm6 hours and sustained-release diclofenac 75 mg12 hours will be administered postoperatively regularly until hospital discharge
IF any patient enrolled in our study complains of a pain score 3 with regard to NPS in spite of the previously mentioned protocol for pain management a rescue of 007 mgkg IV morphine sulphate will be administrated then NPS will be reassessed 15 minutes later if it is still 3 a rescue 005 mgkg IV morphine sulphate will be administered which can be repeated any time postoperatively until NRS is 3 or less provided that total morphine consumption does not exceed 02 mgkg4 hours 12
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