Anesthesia, LocalNCT03744923
Quadratus Lumborum Block (Transmuscular Approach) VS. TransversusAbdominus Plane Block(Unilateral Posterior Approach) for Perioperative Analgesia in Patients Undergoing Flank Incision Surgeries.
A study testing transmuscular QL block and Transversus Abdominus Plane block in people with Anesthesia, Local, run by Cairo University at 1 site in Egypt.
Trial summary
Severe perioperative pain experienced after surgical procedures performed by flank incision is mainly related to incision of many muscles. Postoperative pain affects patient comfort, satisfaction, prolongs the duration of hospital stay and increases post-procedure complications. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- transmuscular QL block and Transversus Abdominus Plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2018to 1 Oct 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients age between >20 and <60.
- Patients scheduled for Urological flank surgery (open nephrectomy)
- Ability to sign the consent
- ASA classification I, II
- Body Mass Index (BMI) < or = 30
- Duration of surgery less than 3 hours
Who cannot join
- Refusal of the regional block.
- Bleeding disorders (INR >1.4 )( platelet count <100,000/mm3 )
- Skin lesions or infection at the site of proposed needle insertion.
- Evidence of peritonitis or septicemia.
- Hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- Patients with ventriculoperitoneal shunts in situ.
Show all 11Show fewer
- Allergy to amide local anesthetics, fentanyl or meperidine.
- Patients suffering from neurological disease.
- ASA classification > II
- BMI > 30
- Duration of surgery more than 3 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesia for Flank Incision Surgeries
Severe perioperative pain experienced after surgical procedures performed by flank incision is mainly related to incision of many muscles. Postoperative pain affects patient comfort, satisfaction, prolongs the duration of hospital stay and increases post-procedure complications. This study is designed to compare the success rate of Unilateral Ultrasound Guided Transmuscular Quadratus Lumborum Block with Unilateral posterior Ultrasound Guided TransversusAbdominus Plane block in providing perioperative analgesia in Patients undergoing Flank Incision surgeries in the Urosurgery Theater at KasrAlainy University Hospitals.
Read the detailed description
Patients aged from 20-60 years old, scheduled for flank surgery procedure will be included in the study. Patients will be randomly allocated using concealed closed envelope method into one of three groups:
Group A (n=16): will receive USG TransmuscularQLB after induction of general anesthesia.
Group B (n=16): will receive unilateral USG posterior TAP Block after induction of General anesthesia.
Group C (n=16): (control group) will not receive any blocks.general anesthesia will be induced using propofol 2-3 mg/kg over 20-30 seconds, fentanyl 2 µg/kg, and atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane 1.5 %, atracurium at a dose of 0.1 mg/kg every 20 minutes. For all patients, fluid management will be strict according to body weight and blood loss will be adequately estimated and replaced. In the three groups, the observing anesthetist will be advised to give fentanyl increment doses (0.5 µg/kg) when mean blood pressure, heart rate or both increased by more than 20% from the baseline, lacrimation or sweating (signs of inadequate analgesia).
Postoperatively, all patients will receive IV paracetamol 1gm every 8 hours. As a rescue analgesic, meperidine (0.5 mg/kg) will be used when VAS score > 4. The following data will be recorded1- Duration of the surgery 2- Time required to perform the blocks in minutes 3- Intraoperative mean blood pressure and heart rate will be recorded in all groups immediately after induction, at the surgical incision and every 15 minutes till the end of the procedure.
4- Total amount of intraoperative fentanyl consumption will be recorded 5- Immediate postoperative blood pressure and heart rate will be recorded 6- Visual Analogue scale (VAS) for pain will be applied postoperatively at rest and during movement. Pain will be assessed with a 10-cm ruler ranging from no pain (0) to severe pain (10). Evaluation will be performed immediately postoperative, at 30 minutes, 1 hour, 2 hours, 4 hours, 6hours and 12 hours postoperatively.
7- The time of the first analgesic request (rescue analgesia) in the postoperative period will be recorded (defined as the time between the end of surgery and the request of the first dose of postoperative analgesics). As a rescue analgesic, meperidine (0.5 mg/kg) will be used when VAS score > 4.
8- Postoperative nausea and vomiting
- Conditions
- Anesthesia, Local
- Being tested
- transmuscular QL block, Transversus Abdominus Plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transmuscular QL blockProcedure or surgery
Ultrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall. Then, scan dorsally keeping the transverse orientation until observing that the transversusabdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle.
The view of the psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process result in a well recognizable pattern of a Shamrock with three leaves (trifoliate).
Transversus Abdominus Plane blockProcedure or surgery
Posterior TAP block will be performed on the same side of surgery (unilateral) under ultrasonographic guidance with a with broadband (7-13MHz) linear probe covered with a sterile plastic sheath. Probe will positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line.
Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, block was performed with 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydrovisualization of needle-tip position and confirming its correct postioning.
| Study group | Role | What they receive |
|---|---|---|
| Transmuscular QLB group | Active comparator | Ultrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall Then, scan dorsally keeping the transverse orientation until observing that the transverse abdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia The needle (20G spinal needle) is inserted in-plane from posterior to anterior and the tip of the needle is advanced towards then through the QL muscle, penetrating the ventral proper fascia of the QL muscle. The target site for injection is the plane between quadratus lumborum and psoas major. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together. Receives: Procedure: transmuscular QL block |
| unilateral posterior TAP block group | Active comparator | under ultrasonographic guidance,the probe will be positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line.
Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid-axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, the block was performed with the 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydro visualization of needle-tip position and confirming its correct positioning. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together. Receives: Procedure: Transversus Abdominus Plane block |
| control group | No intervention | the patients will not receive any blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
fentanyl consumption in the intraopertive period
Measurement of total the amount of fentanyl consumption in the intraopertive period in the three allocated groups as indicator for hemodynamic stability and efficacy of both types of blocks.
Measured: 3 hours
Secondary outcomes (2)
doses of postoperative mepridine analgesics
as an indication of success of the blocks postoperatively
Measured: 24 hours
VAS(visual analogue score)
visual analogue scale for pain assessment postopertively Pain will be assessed with a 10-cm ruler ranging from no pain (0) to severe pain (10).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Nov 2018
- Primary completion20 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hassan Saleh, Cairo University
- Investigators
- kasr alaini hospital, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744923
- Sponsor's protocol ID
- N-36-2018
- Status last verified
- Oct 2019
- First submitted
- 8 Nov 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
PubMed 33762197
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia for Flank Incision Surgeries
- ClinicalTrials.gov ID
- NCT03744923
- Acronym / sponsor ID
- N-36-2018
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 19 Nov 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.
Severe perioperative pain experienced after surgical procedures performed by flank incision is mainly related to incision of many muscles. Postoperative pain affects patient comfort, satisfaction, prolongs the duration of hospital stay and increases post-procedure complications. This study is designed to compare the success rate of Unilateral Ultrasound Guided Transmuscular Quadratus Lumborum Block with Unilateral posterior Ultrasound Guided TransversusAbdominus Plane block in providing perioperative analgesia in Patients undergoing Flank Incision surgeries in the Urosurgery Theater at KasrAlainy University Hospitals.
Detailed description
Patients aged from 20-60 years old, scheduled for flank surgery procedure will be included in the study. Patients will be randomly allocated using concealed closed envelope method into one of three groups:
Group A (n=16): will receive USG TransmuscularQLB after induction of general anesthesia.
Group B (n=16): will receive unilateral USG posterior TAP Block after induction of General anesthesia.
Group C (n=16): (control group) will not receive any blocks.general anesthesia will be induced using propofol 2-3 mg/kg over 20-30 seconds, fentanyl 2 µg/kg, and atracurium 0.5 mg/kg to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane 1.5 %, atracurium at a dose of 0.1 mg/kg every 20 minutes. For all patients, fluid management will be strict according to body weight and blood loss will be adequately estimated and replaced. In the three groups, the observing anesthetist will be advised to give fentanyl increment doses (0.5 µg/kg) when mean blood pressure, heart rate or both increased by more than 20% from the baseline, lacrimation or sweating (signs of inadequate analgesia).
Postoperatively, all patients will receive IV paracetamol 1gm every 8 hours. As a rescue analgesic, meperidine (0.5 mg/kg) will be used when VAS score > 4. The following data will be recorded1- Duration of the surgery 2- Time required to perform the blocks in minutes 3- Intraoperative mean blood pressure and heart rate will be recorded in all groups immediately after induction, at the surgical incision and every 15 minutes till the end of the procedure.
4- Total amount of intraoperative fentanyl consumption will be recorded 5- Immediate postoperative blood pressure and heart rate will be recorded 6- Visual Analogue scale (VAS) for pain will be applied postoperatively at rest and during movement. Pain will be assessed with a 10-cm ruler ranging from no pain (0) to severe pain (10). Evaluation will be performed immediately postoperative, at 30 minutes, 1 hour, 2 hours, 4 hours, 6hours and 12 hours postoperatively.
7- The time of the first analgesic request (rescue analgesia) in the postoperative period will be recorded (defined as the time between the end of surgery and the request of the first dose of postoperative analgesics). As a rescue analgesic, meperidine (0.5 mg/kg) will be used when VAS score > 4.
8- Postoperative nausea and vomiting
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transmuscular QLB group | Active comparator | Procedure: transmuscular QL blockUltrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall Then, scan dorsally keeping the transverse orientation until observing that the transverse abdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia The needle (20G spinal needle) is inserted in-plane from posterior to anterior and the tip of the needle is advanced towards then through the QL muscle, penetrating the ventral proper fascia of the QL muscle. The target site for injection is the plane between quadratus lumborum and psoas major. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together. |
| unilateral posterior TAP block group | Active comparator | Procedure: Transversus Abdominus Plane blockunder ultrasonographic guidance,the probe will be positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line. Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid-axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, the block was performed with the 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydro visualization of needle-tip position and confirming its correct positioning. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together. |
| control group | No intervention | –the patients will not receive any blocks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients age between >20 and <60.
- Patients scheduled for Urological flank surgery (open nephrectomy)
- Ability to sign the consent
- ASA classification I, II
- Body Mass Index (BMI) < or = 30
Key exclusion criteria (11 listed)
- Refusal of the regional block.
- Bleeding disorders (INR >1.4 )( platelet count <100,000/mm3 )
- Skin lesions or infection at the site of proposed needle insertion.
- Evidence of peritonitis or septicemia.
- Hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
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 |
|---|---|---|
| transmuscular QL blockUltrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall. Then, scan dorsally keeping the transverse orientation until observing that the transversusabdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle. The view of the psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process result in a well recognizable pattern of a Shamrock with three leaves (trifoliate). | Procedure or surgery | Transmuscular QLB group |
| Transversus Abdominus Plane blockPosterior TAP block will be performed on the same side of surgery (unilateral) under ultrasonographic guidance with a with broadband (7-13MHz) linear probe covered with a sterile plastic sheath. Probe will positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line. Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, block was performed with 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydrovisualization of needle-tip position and confirming its correct postioning. | Procedure or surgery | unilateral posterior TAP block group |
Primary outcome
fentanyl consumption in the intraopertive period
Time frame: 3 hours
Measurement of total the amount of fentanyl consumption in the intraopertive period in the three allocated groups as indicator for hemodynamic stability and efficacy of both types of blocks.
2 secondary outcomes
doses of postoperative mepridine analgesics
Time frame: 24 hours
VAS(visual analogue score)
Time frame: 24 hours
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 22 Oct 2019.
- Derived from this study: PubMed 33762197Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.
- Individual participant dataSharing planned: No
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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.
kasr alaini hospital study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transmuscular QL block and Transversus Abdominus Plane block in people with Anesthesia, Local, 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 6 inclusion and 11 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 22 Oct 2019. 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?
fentanyl consumption in the intraopertive period (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744923, which also lists 1 linked publication.
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 22 Oct 2019.