BilateralNCT06889987
Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block Versus Bilateral Lateral Quadratus Lumborum Plane Block in Controlling Postoperative Pain in Cancer Patients Undergoing Open Nephrectomy
A study testing Intramuscular quadratus lumborum block, Lateral quadratus lumborum block and General anesthesia in people with Bilateral and Ultrasound, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bilateral, Ultrasound, Intramuscular Quadratus Lumborum Plane Block
- What is being tested?
- Intramuscular quadratus lumborum block, Lateral quadratus lumborum block and General anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to 6 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI): (20- 40) kg/m2.
- Type of surgery: midline incision for unilateral open nephrectomy.
Who cannot join
- Patient refusal.
- Age <18 years or >65 years
- BMI <20 kg/m2 and > 40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia, e.g. local infection at the introduction site, pre-existing peripheral neuropathies and coagulopathy.
- Physical status ASA IV
Show all 10Show fewer
- Patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
- Patients with a history of drug abuse
- Patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
- All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Ahmed M Salama, Master, 00201024275085, dr.Ahmed.ismail93@gmail.com
Mohamed A El-Ramli, MD
About this study
Official title: Efficacy of Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block (Ql4) Versus Bilateral Lateral Quadratus Lumborum Plane Block (Ql1) in Controlling Post-Operative Pain in Cancer Patient Undergoing Open Nephrectomy: A Randomized Control Study
This study aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy.
Read the detailed description
Post-surgical somatic pain is very distressing to patients, which may lead to significant complications.
Practitioners initially used these as ilioinguinal, iliohypogastric, rectus sheath blocks, and in the early 21st century, transversus abdominis plane (TAP) blocks. A recent variation of the TAP block is known as the quadratus lumborum block (QLB).
The QL block effectiveness is believed to result from the spread of Local Anesthetic cranially from the lumbar deposition into the thoracic paravertebral space (TPVS). So, the QLB seems to relieve somatic and visceral pains.
- Conditions
- Bilateral, Ultrasound, Intramuscular Quadratus Lumborum Plane Block, Lateral Quadratus Lumborum Plane Block, Postoperative Pain, Cancer Patients
- Being tested
- Intramuscular quadratus lumborum block, Lateral quadratus lumborum block, General anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular quadratus lumborum blockDrug
Also called Bupivacaine 0.25%
Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia
Lateral quadratus lumborum blockDrug
Also called Bupivacaine 0.25%
Patients will receive bilateral ultrasound-guided lateral quadratus lumborum with an injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia.
General anesthesiaDrug
Patients will receive only general anesthesia without any block.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular quadratus lumborum group | Experimental | Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia. Receives: Drug: Intramuscular quadratus lumborum block |
| Lateral quadratus lumborum group | Experimental | Patients will receive bilateral Ultrasound-guided lateral quadratus lumborum with injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia. Receives: Drug: Lateral quadratus lumborum block |
| Control group | Active comparator | Patients will receive only general anesthesia without any block Receives: Drug: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
The degree of pain will be assessed using the Visual Analogue Scale (VAS) where 0 (no pain) and 10 (the worst pain). VAS score in each technique at 0, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Measured: 24 hours postoperatively
Secondary outcomes (9)
Total amount of morphine consumption
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.
Measured: 24 hours postoperatively
Total amount of fentanyl consumption
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Measured: Intraoperatively
Change in heart rate
Change in heart rate will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Measured: 24 hours postoperatively
Change in mean arterial blood pressure
Change in mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Measured: 24 hours postoperatively
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded.
Measured: 24 hours postoperatively
Time of first rescue analgesia
Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Incidence of complications related to block
Incidence of complications related to block such as local anesthetic systemic toxicity and arterial puncture will be recorded.
Measured: 24 hours postoperatively
Incidence of morphine related complications
Incidence of morphine-related complications such as respiratory depression, urine retention or pruritis will be recorded.
Measured: 24 hours postoperatively
Degree of patient satisfaction
The patient will be classified in this group to be satisfied or not.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start10 Dec 2024
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BilateralStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ismail, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889987
- Sponsor's protocol ID
- AP2412-201-088-194
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block (Ql4) Versus Bilateral Lateral Quadratus Lumborum Plane Block (Ql1) in Controlling Post-Operative Pain in Cancer Patient Undergoing Open Nephrectomy: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06889987
- Acronym / sponsor ID
- AP2412-201-088-194
- Conditions
- Bilateral, Ultrasound, Intramuscular Quadratus Lumborum Plane Block, Lateral Quadratus Lumborum Plane Block, Postoperative Pain, Cancer Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 21 Mar 2025 (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 aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy.
Detailed description
Post-surgical somatic pain is very distressing to patients, which may lead to significant complications.
Practitioners initially used these as ilioinguinal, iliohypogastric, rectus sheath blocks, and in the early 21st century, transversus abdominis plane (TAP) blocks. A recent variation of the TAP block is known as the quadratus lumborum block (QLB).
The QL block effectiveness is believed to result from the spread of Local Anesthetic cranially from the lumbar deposition into the thoracic paravertebral space (TPVS). So, the QLB seems to relieve somatic and visceral pains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intramuscular quadratus lumborum group | Experimental | Drug: Intramuscular quadratus lumborum blockPatients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia. |
| Lateral quadratus lumborum group | Experimental | Drug: Lateral quadratus lumborum blockPatients will receive bilateral Ultrasound-guided lateral quadratus lumborum with injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia. |
| Control group | Active comparator | Drug: General anesthesiaPatients will receive only general anesthesia without any block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status II-III.
- Body mass index (BMI): (20- 40) kg/m2.
- Type of surgery: midline incision for unilateral open nephrectomy.
Key exclusion criteria (10 listed)
- Patient refusal.
- Age <18 years or >65 years
- BMI <20 kg/m2 and > 40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia, e.g. local infection at the introduction site, pre-existing peripheral neuropathies and coagulopathy.
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 |
|---|---|---|
| Intramuscular quadratus lumborum blockAlso: Bupivacaine 0.25%Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia | Drug | Intramuscular quadratus lumborum group |
| Lateral quadratus lumborum blockAlso: Bupivacaine 0.25%Patients will receive bilateral ultrasound-guided lateral quadratus lumborum with an injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia. | Drug | Lateral quadratus lumborum group |
| General anesthesiaPatients will receive only general anesthesia without any block. | Drug | Control group |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
The degree of pain will be assessed using the Visual Analogue Scale (VAS) where 0 (no pain) and 10 (the worst pain). VAS score in each technique at 0, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
9 secondary outcomes
Total amount of morphine consumption
Time frame: 24 hours postoperatively
Total amount of fentanyl consumption
Time frame: Intraoperatively
Change in heart rate
Time frame: 24 hours postoperatively
Change in mean arterial blood pressure
Time frame: 24 hours postoperatively
Incidence of postoperative nausea and vomiting
Time frame: 24 hours postoperatively
Time of first rescue analgesia
Time frame: 24 hours postoperatively
Incidence of complications related to block
Time frame: 24 hours postoperatively
Incidence of morphine related complications
Time frame: 24 hours postoperatively
Degree of patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular quadratus lumborum block, Lateral quadratus lumborum block and General anesthesia in people with Bilateral and Ultrasound, run by National Cancer Institute, Egypt 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 5 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Salama, Master (00201024275085, dr.Ahmed.ismail93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours 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 21 Mar 2025.