Abdominal CancerPhase 3NCT05533424
Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.
A Phase 3 study testing quadratus lumborum and transversus abdominis plane in people with Abdominal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- quadratus lumborum and transversus abdominis plane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 15 Dec 2023
- Phase
- Phase 3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients included in the study, aged 20-60 years,
- with ASA Physical Status Class I and II,
- scheduled for abdominal cancer surgery under general anesthesia
Who cannot join
- infection at injection site,
- allergy to local anesthetics,
- coagulation disorders,
- physical or mental diseases which could interfere with the evaluation of pain scores
- kidney failure or liver failure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nevert Adel Abdel Ghaffar
Al Mansurah
Nevert A Abdel Ghaffar, MD, 01223947977, nevertadel@mans.edu.eg
Yahya M Wahba, MD, 01211313554, yahyawahba@ymail.com
About this study
Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain.
The aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and Transversus abdominis plane blocks for pain management after abdominal cancer surgery.
Read the detailed description
Postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. Therefore, it is very important for perioperative patients to have a safe and effective pain management model. Although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. Recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes.
As effective constituents of multimode analgesia, quadratus lumborum (QL) block and transversus abdominis plane (TAP) block are mainly used for postoperative analgesia in abdominal surgery.
Aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block
- Conditions
- Abdominal Cancer
- Being tested
- quadratus lumborum, transversus abdominis plane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quadratus lumborumOther
the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied
transversus abdominis planeOther
the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side
| Study group | Role | What they receive |
|---|---|---|
| Group quadratus lumborum | Active comparator | the patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied Receives: Other: quadratus lumborum |
| Group transversus abdominis plane | Active comparator | the probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side Receives: Other: transversus abdominis plane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of morphine
amount of morphine in mg
Measured: in the first 24 hours after surgery
Secondary outcomes (6)
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively at 30 min and 2, 4, 6, 12, and 24 hours
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively 2 hours
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively at 4 hours
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively at 6 hours
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively at 12 hours
visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: postoperatively at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533424
- Sponsor's protocol ID
- R.22.08.1787
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block as Postoperative Analgesia in Patients Undergoing Abdominal Cancer Surgery.
- ClinicalTrials.gov ID
- NCT05533424
- Acronym / sponsor ID
- R.22.08.1787
- Conditions
- Abdominal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 9 Sep 2022 (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.
Abdominal surgery is usually associated with severe postoperative pain. The transverse abdominal plane (TAP) block is considered an effective means for pain control in such cases. The quadratus lumborum (QL) block is another option for the management of postoperative pain.
The aim of this study is to evaluate the efficacy and safety of quadrates lumborum blocks and Transversus abdominis plane blocks for pain management after abdominal cancer surgery.
Detailed description
Postoperative pain is severe in patients undergoing abdominal surgery, and severe pain not only affects the rate of recovery of patients but also induces a series of pathophysiological reactions. Therefore, it is very important for perioperative patients to have a safe and effective pain management model. Although classic postoperative analgesia methods can provide effective pain relief after surgery, their administration has a well-defined risk of side effects. Recently, with the rise in enhanced recovery after surgery, nerve blocks have become the key link in multimodal analgesic regimes.
As effective constituents of multimode analgesia, quadratus lumborum (QL) block and transversus abdominis plane (TAP) block are mainly used for postoperative analgesia in abdominal surgery.
Aim of this study is to compare between the analgesic effecacy of quadrates lumborum block and transverses abdominal plane block
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group quadratus lumborum | Active comparator | Other: quadratus lumborumthe patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied |
| Group transversus abdominis plane | Active comparator | Other: transversus abdominis planethe probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients included in the study, aged 20-60 years,
- with ASA Physical Status Class I and II,
- scheduled for abdominal cancer surgery under general anesthesia
Key exclusion criteria (5 listed)
- infection at injection site,
- allergy to local anesthetics,
- coagulation disorders,
- physical or mental diseases which could interfere with the evaluation of pain scores
- kidney failure or liver failure.
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 |
|---|---|---|
| quadratus lumborumthe patient will be positioned supine with lateral tilt , and the transducer was placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles were clearly identified. The external oblique muscle was followed posterolaterally until its posterior border was visualized . The probe was tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip was placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle was proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine was applied | Other | Group quadratus lumborum |
| transversus abdominis planethe probe will located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall were identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique was used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine was injected. The same technique will be performed on the other side | Other | Group transversus abdominis plane |
Primary outcome
The total dose of morphine
Time frame: in the first 24 hours after surgery
amount of morphine in mg
6 secondary outcomes
visual analog score
Time frame: postoperatively at 30 min and 2, 4, 6, 12, and 24 hours
visual analog score
Time frame: postoperatively 2 hours
visual analog score
Time frame: postoperatively at 4 hours
visual analog score
Time frame: postoperatively at 6 hours
visual analog score
Time frame: postoperatively at 12 hours
visual analog score
Time frame: postoperatively at 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing quadratus lumborum and transversus abdominis plane in people with Abdominal Cancer, run by Mansoura 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Sep 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yahya m wahba, assist professor (01211313554, yahyawahba@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total dose of morphine (time frame: in the first 24 hours after surgery). 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 9 Sep 2022.