Postoperative PainNCT03958942
Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery
A study testing Ultrasound quadratus lumborum block with bupivacaine 25% and lumbar epideural block with bupivacaine 25% in people with Postoperative Pain and Inflammatory Response, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Inflammatory Response
- What is being tested?
- Ultrasound quadratus lumborum block with bupivacaine 25% and lumbar epideural block with bupivacaine 25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Mar 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA II, III
- Weight 50 - 85 kg.
- Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).
Who cannot join
- Patients with a history of relevant drug allergy.
- Coagulation disorders.
- Opioid dependence.
- Sepsis.
- Local infection at the vicinity of the block site.
- Patients with psychiatric illnesses that would interfere with perception and assessment of pain
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 171516
Moaaz El tohamy
About this study
Official title: Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery
This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.
- Conditions
- Postoperative Pain, Inflammatory Response
- Being tested
- Ultrasound quadratus lumborum block with bupivacaine 25%, lumbar epideural block with bupivacaine 25%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound quadratus lumborum block with bupivacaine 25%Other
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
lumbar epideural block with bupivacaine 25%Other
lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum block | Active comparator | received 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: Other: Ultrasound quadratus lumborum block with bupivacaine 25% |
| lumbar epideural block | Active comparator | received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA. Receives: Other: lumbar epideural block with bupivacaine 25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain intensity.
Measured: first 24 hours postoperatively
Secondary outcomes (2)
postoperative inflammatory response
inflammatory response represented by the levels of: interleukins 1,6, and tumor necrosis factor alpha
Measured: first 24 hours postoperatively
side effects
sedation, nausea, vomiting, and respiratory depression
Measured: first 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 posted22 May 2019
- Study start1 Jun 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958942
- Sponsor's protocol ID
- 255
- Status last verified
- Jul 2019
- First submitted
- 15 May 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03958942
- Acronym / sponsor ID
- 255
- Conditions
- Postoperative Pain, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 22 May 2019 (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 at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum block | Active comparator | Other: Ultrasound quadratus lumborum block with bupivacaine 25%received 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. |
| lumbar epideural block | Active comparator | Other: lumbar epideural block with bupivacaine 25%received pre-emptive lumbar epidural block with 15 mL of 0.25% bupivacaine before induction of GA. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA II, III
- Weight 50 - 85 kg.
- Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).
Key exclusion criteria (6 listed)
- Patients with a history of relevant drug allergy.
- Coagulation disorders.
- Opioid dependence.
- Sepsis.
- Local infection at the vicinity of the block site.
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 quadratus lumborum block with bupivacaine 25%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 | Other | quadratus lumborum block |
| lumbar epideural block with bupivacaine 25%lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique. | Other | lumbar epideural block |
Primary outcome
postoperative pain
Time frame: first 24 hours postoperatively
postoperative pain intensity.
2 secondary outcomes
postoperative inflammatory response
Time frame: first 24 hours postoperatively
side effects
Time frame: first 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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 study testing Ultrasound quadratus lumborum block with bupivacaine 25% and lumbar epideural block with bupivacaine 25% in people with Postoperative Pain and Inflammatory Response, run by Assiut 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 6 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 5 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Abd El-Rahman, M.D. (00201149606060, ahmad23679@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: first 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 5 Jul 2019.