Post Operative PainNCT04848363
Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
A study testing Quadratus lumborum block in people with Post Operative Pain, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 16 Jun 2021to 30 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.
- Patient's willingness and ability to sign an informed consent document
Who cannot join
- Allergy to local anesthetics
- Chronic pain syndrome and associated opioid use.
- Coagulopathy
- Uncontrolled diabetes mellitus
- Physical Status Classification System scale above 3
- Diseases associated with the pathology of the hypothalamus
- Diseases associated with the pathology of the pituitary gland
- Diseases associated with the pathology of the adrenal glands
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
Moscow, 119991
Evgenii Bespalov, +79854633843, evgenbespalovv@yandex.ru
About this study
Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.
Read the detailed description
All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.
All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale > 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.
- Conditions
- Post Operative Pain
- Being tested
- Quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before the operation, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml. Receives: Procedure: Quadratus lumborum block |
| Control group | Placebo comparator | patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before surgery, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of saline. Receives: Procedure: Quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numeric rating scale)
NRS scale 0-10, "no pain"; 10, "worst pain imaginable"
Measured: two hours after surgery
Secondary outcomes (8)
The need for opioid analgesics during surgery
Measured: on operations
The need for opioid analgesics for postoperative pain relief
Measured: 72 hours after surgery
The need for antiemetic drugs to relieve postoperative nausea and vomiting
Measured: 12 hours after the surgery
Occurrence of prolonged post-operative ileus
Measured: first two weeks after surgery
Blood glucose level
Measured: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
The level of blood lactate
Measured: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
The level of cortisol in the blood
Measured: after induction into anesthesia and immediately after the end of the surgery
The level of prolactin in the blood
Measured: after induction into anesthesia and immediately after the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Jun 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Distribution: randomized Intervention model: parallel distribution 2 groups * Control group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. Before surgery will be performde bilateral blockade of the QL muscle with normal saline. * Study group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. The QL blockade will be performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgenii Bespalov,MD, Petrovsky National Research Centre of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848363
- Sponsor's protocol ID
- BEK25011994
- Status last verified
- Jun 2021
- First submitted
- 12 Mar 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data will be confidential
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
- ClinicalTrials.gov ID
- NCT04848363
- Acronym / sponsor ID
- BEK25011994
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 19 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.
Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.
Detailed description
All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.
All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale > 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Distribution: randomized Intervention model: parallel distribution 2 groups * Control group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. Before surgery will be performde bilateral blockade of the QL muscle with normal saline. * Study group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. The QL blockade will be performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Quadratus lumborum blockpatients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before the operation, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml. |
| Control group | Placebo comparator | Procedure: Quadratus lumborum blockpatients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before surgery, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.
- Patient's willingness and ability to sign an informed consent document
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Chronic pain syndrome and associated opioid use.
- Coagulopathy
- Uncontrolled diabetes mellitus
- Physical Status Classification System scale above 3
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 lumborum blockQL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%. | Procedure or surgery | Control group, Study group |
Primary outcome
NRS (Numeric rating scale)
Time frame: two hours after surgery
NRS scale 0-10, "no pain"; 10, "worst pain imaginable"
8 secondary outcomes
The need for opioid analgesics during surgery
Time frame: on operations
The need for opioid analgesics for postoperative pain relief
Time frame: 72 hours after surgery
The need for antiemetic drugs to relieve postoperative nausea and vomiting
Time frame: 12 hours after the surgery
Occurrence of prolonged post-operative ileus
Time frame: first two weeks after surgery
Blood glucose level
Time frame: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
The level of blood lactate
Time frame: after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery
The level of cortisol in the blood
Time frame: after induction into anesthesia and immediately after the end of the surgery
The level of prolactin in the blood
Time frame: after induction into anesthesia and immediately after the end of the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No. All patient data will be confidential
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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 Quadratus lumborum block in people with Post Operative Pain, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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 2 inclusion and 8 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 18 Jun 2021. 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 Russia. 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. 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 Evgenii Bespalov (+79854633843, evgenbespalovv@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (Numeric rating scale) (time frame: two 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 18 Jun 2021.