Ultrasound Guided L1,L2 Paravertebral BlockNCT03422354
Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries.
A study testing Ultrasound guided PVB with General Aneasthesia, Ultrasound and Paravertebral block in people with Ultrasound Guided L1,L2 Paravertebral Block, run by Cairo University at 1 site in Egypt.
Trial summary
The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves injection of local anaesthetic in a space… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Guided L1,L2 Paravertebral Block
- What is being tested?
- Ultrasound guided PVB with General Aneasthesia, Ultrasound and Paravertebral block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2018to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Extremes of age.
- ASA III-IV.
- Hypovolemia.
- Increased intracranial pressure.
- Coagulopathy or thrombocytopenia less than 100000/ml.
- Sepsis (increased risk of meningitis).
Show all 10Show fewer
- Infection at the puncture site.
- Pre-existing neurologic disease.
- Patient refusal.
- History of allergy to local anesthetic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries
The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.(4) The increasing demand for hip arthroplasties over the last decades has sparked the creation of new and innovative anesthetic techniques and analgesic pathways with the goal to support best possible outcomes among this frequently elderly patient population. As a result, today different perioperative treatment pathways are available to physicians and their patients. In this context, the focus has shifted to techniques based on regional anesthetic and analgesic techniques. This trajectory has been fueled by a number of advantages including effective, long-lasting and focused pain control, decreased need for systemic analgesics and earlier mobilization.
Read the 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.
- Being tested
- Ultrasound guided PVB with General Aneasthesia, Ultrasound, Paravertebral block, General Aneasthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided PVB with General AneasthesiaProcedure or surgery
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
UltrasoundDevice
Ultrasound
Paravertebral blockDrug
Patients will receive single shot L1-L2 PVB before undergoing GA
General AneasthesiaDrug
General Aneasthesia
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block Group | Active comparator | 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. Receives: Procedure: Ultrasound guided PVB with General Aneasthesia; Device: Ultrasound; Drug: Paravertebral block; Drug: General Aneasthesia |
| General anesthesia Group | Active comparator | 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 Receives: Device: Ultrasound; Drug: General Aneasthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of hypotensive drugs
Required dose of hypotensive drugs in both groups
Measured: One day postoperatively
Secondary outcomes (2)
Pain assessment
Pain assessment by the aid of Visual analogue scale (VAS)
Measured: One day postoperatively
Total dose of opioids
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
Measured: One day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start12 Feb 2018
- Primary completion10 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided L1,L2 Paravertebral BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- after approval of the ethical committee (N-73-2017)Which approval date was 12/2/2018 74 patients scheduled for elective hip surgery were included in the study after detailed description and signing a detailed informative consent (figure1). The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups: * Group P: 37 patients were received single shot L1-L2 paravertebral block before undergoing general anesthesia (GA). * Group G: 37 patients were received GA. The target of the mean blood pressure was to be more than 50mm Hg while the systolic pressure to be between 80 and 100 mm Hg and the diastolic blood pressure targeted to be 50 to 70 mmHg.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Hala Mostafa Gomaa, Abdelhamid, Bassant Mohamed, M.D., Mohamed saeid Ali
- Responsible party
- Principal investigator, Ahmed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422354
- Sponsor's protocol ID
- N -73/2017
- Status last verified
- May 2018
- First submitted
- 27 Dec 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Via scholar Gate
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries
- ClinicalTrials.gov ID
- NCT03422354
- Acronym / sponsor ID
- N -73/2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Mohamed, Ahmed A., M.D., Hala Mostafa Gomaa, Abdelhamid, Bassant Mohamed, M.D., Mohamed saeid Ali
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.(4) The increasing demand for hip arthroplasties over the last decades has sparked the creation of new and innovative anesthetic techniques and analgesic pathways with the goal to support best possible outcomes among this frequently elderly patient population. As a result, today different perioperative treatment pathways are available to physicians and their patients. In this context, the focus has shifted to techniques based on regional anesthetic and analgesic techniques. This trajectory has been fueled by a number of advantages including effective, long-lasting and focused pain control, decreased need for systemic analgesics and earlier mobilization.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- after approval of the ethical committee (N-73-2017)Which approval date was 12/2/2018 74 patients scheduled for elective hip surgery were included in the study after detailed description and signing a detailed informative consent (figure1). The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups: * Group P: 37 patients were received single shot L1-L2 paravertebral block before undergoing general anesthesia (GA). * Group G: 37 patients were received GA. The target of the mean blood pressure was to be more than 50mm Hg while the systolic pressure to be between 80 and 100 mm Hg and the diastolic blood pressure targeted to be 50 to 70 mmHg.
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block Group | Active comparator | Procedure: Ultrasound guided PVB with General Aneasthesia, Device: Ultrasound, Drug: Paravertebral block, Drug: General AneasthesiaPatients 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. |
| General anesthesia Group | Active comparator | Device: Ultrasound, Drug: General AneasthesiaPatients 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- Extremes of age.
- ASA III-IV.
- Hypovolemia.
- Increased intracranial pressure.
- Coagulopathy or thrombocytopenia less than 100000/ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided PVB with General AneasthesiaAn 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 | Procedure or surgery | Paravertebral block Group |
| UltrasoundUltrasound | Device | General anesthesia Group, Paravertebral block Group |
| Paravertebral blockPatients will receive single shot L1-L2 PVB before undergoing GA | Drug | Paravertebral block Group |
| General AneasthesiaGeneral Aneasthesia | Drug | General anesthesia Group, Paravertebral block Group |
Primary outcome
Dose of hypotensive drugs
Time frame: One day postoperatively
Required dose of hypotensive drugs in both groups
2 secondary outcomes
Pain assessment
Time frame: One day postoperatively
Total dose of opioids
Time frame: One day postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: No. Via scholar Gate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided PVB with General Aneasthesia, Ultrasound and Paravertebral block in people with Ultrasound Guided L1,L2 Paravertebral Block, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of hypotensive drugs (time frame: One day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.