- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422354
Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries.
Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries
Study Overview
Status
Conditions
Detailed Description
Paravertebral block group: The patient will be reviewed then moved to the block area. Intravenous access, commencement of IV crystalloid, and standard patient monitoring with ECG , NIBP , pulse oximetry Sedation 2 mg midazolam and oxygen will be commenced prior to insertion of the block.
The equipments area 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle), Skin antiseptic solution, Sterile gloves, marking pen, 1-2 ml of 1% lignocaine for skin infiltration and 20 ml of 0.25% Bupivacain.
The patient will be positioned in lateral decubitus position with the side to be blocked upward and supported by an attendant. The back should assume kyphosis.
The following boney surface anatomy landmarks are helpful to identify spinal levels and to estimate the position of the transverse processes: Iliac crest (corresponds to L3-4 or L2-3), Spinous processes (midline) , Tips of scapulae (corresponds to T7), Midline and 2.5 cm lateral to the midline.
The level between L1 and L2 will be identified using ultrasound as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25 %( 10ml for each level) will be injected slowly after negative aspiration was confirmed at each level.
An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) was applied longitudinally to the paravertebral area.
An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an out-of-plane approach. This was then directed over the top of the bony structure. The deviation of the needle from the perpendicular line was kept at 15°. The paravertebral space was identified using loss of resistance to normal saline injection without ultrasound. After negative aspiration, Transverse process visualisation was possible. Distances measured using ultrasound correlated well with needle depth. Injection of local anaesthetic was visualised as turbulence at L1,2 in all patients. Ultrasound imaging not only helped determine needle insertion sites, but also provides information on the depth to the paravertebral space.
The onset time for this block is 15-25 min. The first sign of the blockade is the loss of pin-prick sensation at the dermatomal distribution of the L1 and L2 roots.
After finishing the block the patient will be moved to the operation room.
All patients in the study will receive general anesthesia in the form of propofol 2mg/kg , atracurium0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation , full monitoring with ECG , NIBP , puls oximetry will be applied.
To control intraoperative blood pressure, fentanyl will be used as well as, hypotensive drugs ( propranolol and nitroglycerineand the total dose will be recorded.
To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg ) will be added when needed.
All the doses of the drugs intraoperative and postoperative will be collected.
After completion of surgical procedure and emergence from anesthesia the patient will be referred to the recovery then will be discharged to ward unit by request of surgeon for close observation.
Hemodynamics will be recorded; requirements for opioids and hypotensive drugs will be recorded and observing postoperative pain and postoperative analgesic requirements.
Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 2,4, 6, 8,12 and 24 hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11451
- Ahmed Abdalla Mohamed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients from 20 to 60 years.
- Genders eligible for study: both.
- ASA I-II.
- No contraindications for application of regional anesthesia as Patient refusal, local anesthetic, allergy, local sepsis or infection at puncture site, INR > 1.5 or < 12 hours post LMWH.
Exclusion Criteria:
- Extremes of age.
- ASA III-IV.
- Hypovolemia.
- Increased intracranial pressure.
- Coagulopathy or thrombocytopenia less than 100000/ml.
- Sepsis (increased risk of meningitis).
- Infection at the puncture site.
- Pre-existing neurologic disease.
- Patient refusal.
- History of allergy to local anesthetic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Paravertebral block Group
Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied.
The level between L1 and L2 will be identified using U/S as well as transverse processes depth.
Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process.
The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm.
Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
|
Ultrasound
An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an out-of-plane approach.
This then directed over the top of the bony structure.
The deviation of the needle was kept at 15°.
The space was identified using loss of resistance without U/S After negative aspiration, Transverse process visualisation was possible.
Distances measured using U/S correlated well with needle depth.
Injection of local anaesthetic was visualised as turbulence at L1,2 in all patients.
The onset time for this block is 15-25 min
Patients will receive single shot L1-L2 PVB before undergoing GA
General Aneasthesia
|
ACTIVE_COMPARATOR: General anesthesia Group
Patients will receive only GA All patients in the study will receive GA in the form of propofol 2mg/kg , atracurium 0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation , full monitoring with ECG , NIBP and puls oximetry will be applied. To control intraoperative BP,fentanyl will be used as well as,hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded. To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg ) will be added when needed |
Ultrasound
General Aneasthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose of hypotensive drugs
Time Frame: One day postoperatively
|
Required dose of hypotensive drugs in both groups
|
One day postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain assessment
Time Frame: One day postoperatively
|
Pain assessment by the aid of Visual analogue scale (VAS)
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One day postoperatively
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Total dose of opioids
Time Frame: One day postoperatively
|
Any additional analgesia during the 1st 24 hours will be covered by paracetamol 1000 mg IV infusion slowly on 10 minutes according to the patient's request.
After 24 hours the total doses will be calculated
|
One day postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood transfusion recorded
Time Frame: One day postoperatively
|
Need for intraoperative blood transfusion will be recorded
|
One day postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N -73/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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