QLB in Lower Abdominal Cancer Surgeries as a Post Operative AnalgesiaNCT06301789
Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries
A study testing Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries in people with QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia, run by Assiut University.
Trial summary
The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia
- What is being tested?
- Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Mar 2026
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 80 years old
- Both gender
- Weight from 55 to 85 kg
- ASA groups 2 and 3
- Lower abdominal cancer surgeries
Who cannot join
- 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Adding Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia in Lower Abdominal Cancer Surgeries.
The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.
Read the detailed description
It is vital to apply adequate postoperative analgesia following lower abdominal surgeries of cancer because Postoperative pain not only affects the patients' rest but also produces a series of pathological reactions. Postoperative analgesia, including regional anesthesia, is very important which not only provides effective postoperative analgesia but also reduces the need for postoperative opioids.In recent years, various ultrasound-guided regional anethetic techniques have been extensively used. One of them is Quadratus lumborum block which can provide postoperative analgesia of the segmental innervation from T6 to L1. In which the Local anesthetics can spread through the thoracolumbar fascia to the paravertebral space, thereby blocking part of the sympathetic nerves . Clinical studies have shown that compared with the current widely used transverse abdominal block, QLB provides longer analgesia and wider block levels when the same dose of local anesthetic is used unlike traditional trunk block, QLB cannot use the sense of falling during puncture and can only be performed under ultrasound guidance, which has the advantages of being real-time and dynamic. Ultrasound-guided nerve block provides more accurate positioning and benefits for patients with less injury. Magnesium sulfate plays an important role in the physiological function of the human body. A large number of studies have reported the safety and effectiveness of adding magnesium sulfate as an adjuvant in various regional anethetic techniques . Therefore, we designed a prospective randomized controlled trial to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.
- Being tested
- Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeriesDrug
Bilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | receive pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA. Receives: Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries |
| InterventionalGroup | Experimental | received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine plus 2 ml of magnesium sulfate 10 % on each side of the abdominal wall before induction of GA. Receives: Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Total morphine consumption during first 24hr postoperative
Measured: First 24 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for QLB in Lower Abdominal Cancer Surgeries as a Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in cases of lower abdominal cancer surgeries
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Aweda Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301789
- Sponsor's protocol ID
- Quadratus lumborum block
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pelausa EO. Otolaryngology in Atlantic Canada: practitioners' perspectives. J Otolaryngol. 1999 Feb;28(1):31-6.
PubMed 10077781Mintz S, Anavi Y, Sabes WR. Peripheral ameloblastoma of the gingiva. A case report. J Periodontol. 1990 Oct;61(10):649-52. doi: 10.1902/jop.1990.61.10.649.
PubMed 2231232Smith BE, Suchak M, Siggins D, Challands J. Rectus sheath block for diagnostic laparoscopy. Anaesthesia. 1988 Nov;43(11):947-8. doi: 10.1111/j.1365-2044.1988.tb05658.x.
PubMed 2975148
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia in Lower Abdominal Cancer Surgeries.
- ClinicalTrials.gov ID
- NCT06301789
- Acronym / sponsor ID
- Quadratus lumborum block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 8 Mar 2024 (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 aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.
Detailed description
It is vital to apply adequate postoperative analgesia following lower abdominal surgeries of cancer because Postoperative pain not only affects the patients' rest but also produces a series of pathological reactions. Postoperative analgesia, including regional anesthesia, is very important which not only provides effective postoperative analgesia but also reduces the need for postoperative opioids.In recent years, various ultrasound-guided regional anethetic techniques have been extensively used. One of them is Quadratus lumborum block which can provide postoperative analgesia of the segmental innervation from T6 to L1. In which the Local anesthetics can spread through the thoracolumbar fascia to the paravertebral space, thereby blocking part of the sympathetic nerves . Clinical studies have shown that compared with the current widely used transverse abdominal block, QLB provides longer analgesia and wider block levels when the same dose of local anesthetic is used unlike traditional trunk block, QLB cannot use the sense of falling during puncture and can only be performed under ultrasound guidance, which has the advantages of being real-time and dynamic. Ultrasound-guided nerve block provides more accurate positioning and benefits for patients with less injury. Magnesium sulfate plays an important role in the physiological function of the human body. A large number of studies have reported the safety and effectiveness of adding magnesium sulfate as an adjuvant in various regional anethetic techniques . Therefore, we designed a prospective randomized controlled trial to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in cases of lower abdominal cancer surgeries
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeriesreceive pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA. |
| InterventionalGroup | Experimental | Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeriesreceived pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine plus 2 ml of magnesium sulfate 10 % on each side of the abdominal wall before induction of GA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 80 years old
- Both gender
- Weight from 55 to 85 kg
- ASA groups 2 and 3
- Lower abdominal cancer surgeries
Key exclusion criteria (1 listed)
- 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use
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 |
|---|---|---|
| Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeriesBilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle | Drug | Control Group, InterventionalGroup |
Primary outcome
Postoperative analgesia
Time frame: First 24 hrs postoperative
Total morphine consumption during first 24hr postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 10077781Pelausa EO. Otolaryngology in Atlantic Canada: practitioners' perspectives. J Otolaryngol. 1999 Feb;28(1):31-6.
- Background: PubMed 2231232Mintz S, Anavi Y, Sabes WR. Peripheral ameloblastoma of the gingiva. A case report. J Periodontol. 1990 Oct;61(10):649-52. doi: 10.1902/jop.1990.61.10.649.
- Background: PubMed 2975148Smith BE, Suchak M, Siggins D, Challands J. Rectus sheath block for diagnostic laparoscopy. Anaesthesia. 1988 Nov;43(11):947-8. doi: 10.1111/j.1365-2044.1988.tb05658.x.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries in people with QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia, run by Assiut University.
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 1 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 8 Mar 2024. 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. Some participants in this study may receive a placebo. 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 Martha Aweda, Resedent dr (01201538885, marthaweda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: First 24 hrs 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 NCT06301789, which also lists 3 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 8 Mar 2024.