Postoperative AnalgesiaNCT04827043
Quadratus Lumborum Block Versus Thoracic Paravertebral Block
A study testing Ultrasound guided quadratus lumborum block and Ultrasound guided thoracic paravertebral block in people with Postoperative Analgesia, run by National Cancer Institute, Egypt.
Trial summary
This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Ultrasound guided quadratus lumborum block and Ultrasound guided thoracic paravertebral block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 30 Sep 2021
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
- Inclusion criteria
- ASA I-III.
- Age ≥ 20 \& ≤ 70
- Body mass index (BMI): Less than forty and more than twenty.
- Patients undergoing major gynacological cancer surgeries.
- Exclusion criteria
- Patient refusal.
- History of sensitivity to local anesthetic (amide group).
- History of psychological disorders.
- Coagulopathies: hereditary (e.g. hemophilia, fibrinogen abnormalities\& deficiency of factor II) - acquired (e.g. liver disease, vitamin K deficiency \& therapeutic anticoagulants drugs).
- Localized infection.
- Morbid obese BMI>40.
- Incooperative patients.
- Patients on chronic pain therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Quadratus Lumborum Block Versus Thoracic Paravertebral Block in Gynacological Cancer Surgery
This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients.
Read the detailed description
All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g. complete blood picture, coagulation profile , liver \& kidney functions , ECG for patient above 40 years, chest x-ray for patients above 60 years and any other necessary investigations required for risky patients. ) }.
The patients will be randomly allocated into two equal groups(25 patients for each group) with a computer-generated list (www.Random.org).
QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg \& 3mg/Kg with epinephrine).
PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10.
- In the recovery room, the patients will be continuous monitored for pulse, blood pressure, oxygen saturation.
- Humidified oxygen 3L/min. by nasal prong will be delivered to all patients.
- Portable ultrasound machine , nerve stimulator, pressure injector monitor ,resuscitation equipment \&drugs (e.g. epinephrine, lipid emulsion ), sterile gloves and surgical towels should be available.
- Intravenous(IV) 18 gauge cannula will be inserted. Midazolam 0.02 mg/Kg will be administered.
While the patients in the supine or lateral position, they will receive bilateral single injection ultrasound guided QLBs under complete sterilization of the abdomen with sterile solution (iodine povacryl \& isopropyl alcohol solution). All patients will be monitored throughout the performance of the block \& all data will be recorded. A linear ultrasound transducer probe (6-13MHZ), or curved probe (according to patients BMI). ( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the level of the anterosuperior iliac spine and moved cranially until the three muscle layers of the abdomen will be identified: external oblique, internal oblique, and transversus abdominis muscles. The external oblique muscle will be followed posterolaterally until its posterior border visualize (hook sign) leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the intermediate layer of the thoracolumber fascia(Blanco et al.,2015).
A 21 gauge blunt, insulated, echogenic needle will be inserted in plane . The optimal point of injection will be determined using hydrodissection (3-5 mL normal saline). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) \& pressure injector monitor.
After negative aspiration, we will inject 0.3mL/Kg bupivacaine 0.25% in each side in QLB group. The patients will be monitored for about 20-30 minutes before induction of anesthesia.
While the TPVB will be performed by single injections at the level of T10 vertebra. The patients will be placed in the sitting position, and the spinal process of T10 will be palpated. Then a linear ultrasound transducer probe (6-13 MHZ).
( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the corresponding transverse process to be clearly visualized and the skin-transverse process distance will be measured on both sides. After infiltration of the skin and subcutaneous tissue with 1% lidocaine with epinephrine 5ug/ml, an 18G Touphy needle will be inserted perpendicular to the skin, approximately 2.5 cm from midline, until contact with the transverse process will be established ( It is important to visualize the pleura very clearly at all times ). The needle will then slightly withdrawal \& reinserted 1-1.5 cm deeper either caudally or cranially for the transverse process (TP). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) \& pressure injector monitor.
After careful aspiration, patients will be received a slow injection of 0.25mL/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml at the level of T10. The patients will be monitored for about 30 minutes before induction of anesthesia. Induction of general anesthesia will be done.
After full awakening from anesthesia, the patient will be transferred to the recovery room. In the recovery room, the patient will be continuous monitored \& humidified oxygen will be applied for about 1 hour. Then a standardized analgesic regimen consisting of regular IV/oral paracetamol 1g every 6 hours combined with PCA morphine (on demand) will be initiated. Patients required additional analgesia will be received IV ketorolac(15-30mg).
A trained anesthetist not involved in the study \& blinded to the patient group will measure the VAS, morphine requirements \& patient satisfaction.
- Conditions
- Postoperative Analgesia
- Being tested
- Ultrasound guided quadratus lumborum block, Ultrasound guided thoracic paravertebral block
- Keywords
- Quadratus lumborum block, Thoracic paravertebral block, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided quadratus lumborum blockCombination product
Also called QLB
prospective randomized comparative study between Group (1) : quadratus lumborum block
Ultrasound guided thoracic paravertebral blockCombination product
Also called PVB
PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Experimental | QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg \& 3mg/Kg with epinephrine), single injection sonar guided. Receives: Combination Product: Ultrasound guided quadratus lumborum block |
| Thoracic paravertebral block | Experimental | PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided. Receives: Combination Product: Ultrasound guided thoracic paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Pain score will be measured according to severity
Measured: Baseline pain till first 24 hours postoperative
Secondary outcomes (2)
Morphine demands postoperative
The amount of morphine required to relieve pain will be recorded
Measured: First 24 hours postoperative
Patient satisfaction
Patient satisfaction measured by visual analogue score
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized comparative study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Fatma Gomaa Hussein, National Cancer Institute, Egypt
- Investigators
- Khaled A El-samahy, Professor, Study director, National Cancer Institute (NCI)Ekramy M Abd-elghaffar, MD, Study director, National Cancer Institute (NCI)Esam Ab Mahran, MD, Study director, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827043
- Sponsor's protocol ID
- Quadratuslumborum block & TPVB
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Starting in April 2021 Ending in July 2021
Publications
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Quadratus Lumborum Block Versus Thoracic Paravertebral Block in Gynacological Cancer Surgery
- ClinicalTrials.gov ID
- NCT04827043
- Acronym / sponsor ID
- Quadratuslumborum block & TPVB
- Conditions
- Postoperative Analgesia
- Keywords
- Quadratus lumborum block, Thoracic paravertebral block, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 1 Apr 2021 (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.
This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients.
Detailed description
All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g. complete blood picture, coagulation profile , liver \& kidney functions , ECG for patient above 40 years, chest x-ray for patients above 60 years and any other necessary investigations required for risky patients. ) }.
The patients will be randomly allocated into two equal groups(25 patients for each group) with a computer-generated list (www.Random.org).
QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg \& 3mg/Kg with epinephrine).
PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10.
- In the recovery room, the patients will be continuous monitored for pulse, blood pressure, oxygen saturation.
- Humidified oxygen 3L/min. by nasal prong will be delivered to all patients.
- Portable ultrasound machine , nerve stimulator, pressure injector monitor ,resuscitation equipment \&drugs (e.g. epinephrine, lipid emulsion ), sterile gloves and surgical towels should be available.
- Intravenous(IV) 18 gauge cannula will be inserted. Midazolam 0.02 mg/Kg will be administered.
While the patients in the supine or lateral position, they will receive bilateral single injection ultrasound guided QLBs under complete sterilization of the abdomen with sterile solution (iodine povacryl \& isopropyl alcohol solution). All patients will be monitored throughout the performance of the block \& all data will be recorded. A linear ultrasound transducer probe (6-13MHZ), or curved probe (according to patients BMI). ( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the level of the anterosuperior iliac spine and moved cranially until the three muscle layers of the abdomen will be identified: external oblique, internal oblique, and transversus abdominis muscles. The external oblique muscle will be followed posterolaterally until its posterior border visualize (hook sign) leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the intermediate layer of the thoracolumber fascia(Blanco et al.,2015).
A 21 gauge blunt, insulated, echogenic needle will be inserted in plane . The optimal point of injection will be determined using hydrodissection (3-5 mL normal saline). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) \& pressure injector monitor.
After negative aspiration, we will inject 0.3mL/Kg bupivacaine 0.25% in each side in QLB group. The patients will be monitored for about 20-30 minutes before induction of anesthesia.
While the TPVB will be performed by single injections at the level of T10 vertebra. The patients will be placed in the sitting position, and the spinal process of T10 will be palpated. Then a linear ultrasound transducer probe (6-13 MHZ).
( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the corresponding transverse process to be clearly visualized and the skin-transverse process distance will be measured on both sides. After infiltration of the skin and subcutaneous tissue with 1% lidocaine with epinephrine 5ug/ml, an 18G Touphy needle will be inserted perpendicular to the skin, approximately 2.5 cm from midline, until contact with the transverse process will be established ( It is important to visualize the pleura very clearly at all times ). The needle will then slightly withdrawal \& reinserted 1-1.5 cm deeper either caudally or cranially for the transverse process (TP). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) \& pressure injector monitor.
After careful aspiration, patients will be received a slow injection of 0.25mL/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml at the level of T10. The patients will be monitored for about 30 minutes before induction of anesthesia. Induction of general anesthesia will be done.
After full awakening from anesthesia, the patient will be transferred to the recovery room. In the recovery room, the patient will be continuous monitored \& humidified oxygen will be applied for about 1 hour. Then a standardized analgesic regimen consisting of regular IV/oral paracetamol 1g every 6 hours combined with PCA morphine (on demand) will be initiated. Patients required additional analgesia will be received IV ketorolac(15-30mg).
A trained anesthetist not involved in the study \& blinded to the patient group will measure the VAS, morphine requirements \& patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Experimental | Combination Product: Ultrasound guided quadratus lumborum blockQLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg \& 3mg/Kg with epinephrine), single injection sonar guided. |
| Thoracic paravertebral block | Experimental | Combination Product: Ultrasound guided thoracic paravertebral blockPVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 quadratus lumborum blockAlso: QLBprospective randomized comparative study between Group (1) : quadratus lumborum block | Combination product | Quadratus lumborum block |
| Ultrasound guided thoracic paravertebral blockAlso: PVBPVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided. | Combination product | Thoracic paravertebral block |
Primary outcome
Visual analogue scale
Time frame: Baseline pain till first 24 hours postoperative
Pain score will be measured according to severity
2 secondary outcomes
Morphine demands postoperative
Time frame: First 24 hours postoperative
Patient satisfaction
Time frame: First 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Individual participant dataSharing planned: Yes. Starting in April 2021 Ending in July 2021
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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.
Khaled A El-samahy, Professor study director
National Cancer Institute (NCI)
Ekramy M Abd-elghaffar, MD study director
National Cancer Institute (NCI)
Esam Ab Mahran, MD study director
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided quadratus lumborum block and Ultrasound guided thoracic paravertebral block in people with Postoperative Analgesia, run by National Cancer Institute, Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma G Hussein, master (00201023431090, fatmagomaa54p@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: Baseline pain till first 24 hours postoperative). 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 NCT04827043, which also lists 2 linked publications.
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 1 Apr 2021.