AnalgesiaNCT04364906
Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery
A study testing Regional anesthesia in people with Analgesia and Acute Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Analgesia, Acute Pain, Chronic Pain
- What is being tested?
- Regional anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2020to 15 Sep 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being pregnant for at least 37 weeks
- Planning an elective cesarean operation
- Being between the ages of 18-45
Who cannot join
- ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)
- Being operated with general anesthesia
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Hypersensitivity to local anesthetics or a history of allergy
- Patients with a history of opioid use longer than four weeks
Show all 9Show fewer
- Patients with psychiatric disorders
- Patients with anatomic deformity
- Patients who do not want to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Faculty of Medicine
Samsun, Other, 55200
About this study
Official title: Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery
This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery.
Read the detailed description
In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.
In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
- Conditions
- Analgesia, Acute Pain, Chronic Pain
- Being tested
- Regional anesthesia
- Keywords
- Regional Anesthesia, Acute and chronical pain, Quadratus Lumborum Blocks, Cesarean Section, Spinal Anesthesia
- Medical subject headings
- Agnosia, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaOther
Also called Quadratus Lumborum Block 2, Quadratus Lumborum Block 3
The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block 2 | Active comparator | Quadratus Lumborum Block 2 (QLB 2) will be performed the patients in Group A after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively Receives: Other: Regional anesthesia |
| Quadratus Lumborum Block 3 | Active comparator | Quadratus Lumborum Block 3 (QLB 3) will be performed the patients in Group B after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively Receives: Other: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA). Patients will be able to request opioids via PCA device when the nrs score is above 4.
Measured: 1 day
Secondary outcomes (1)
Post-operative acute pain
Pain status will be evaluated based on NRS scores. Pain status will be evaluated at 1, 3, 6, 9, 12, 18, 24. hours after surgery. Each NRS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start29 Apr 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Genç, Ondokuz Mayıs University
- Investigators
- ERSİN KÖKSAL, MD, Study director, Ondokuz Mayıs University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364906
- Sponsor's protocol ID
- QL20011990
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery
- ClinicalTrials.gov ID
- NCT04364906
- Acronym / sponsor ID
- QL20011990
- Conditions
- Analgesia, Acute Pain, Chronic Pain
- Keywords
- Regional Anesthesia, Acute and chronical pain, Quadratus Lumborum Blocks, Cesarean Section, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 28 Apr 2020 (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 evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery.
Detailed description
In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.
In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block 2 | Active comparator | Other: Regional anesthesiaQuadratus Lumborum Block 2 (QLB 2) will be performed the patients in Group A after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively |
| Quadratus Lumborum Block 3 | Active comparator | Other: Regional anesthesiaQuadratus Lumborum Block 3 (QLB 3) will be performed the patients in Group B after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being pregnant for at least 37 weeks
- Planning an elective cesarean operation
- Being between the ages of 18-45
Key exclusion criteria (9 listed)
- ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)
- Being operated with general anesthesia
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Hypersensitivity to local anesthetics or a history of allergy
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 |
|---|---|---|
| Regional anesthesiaAlso: Quadratus Lumborum Block 2, Quadratus Lumborum Block 3The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery | Other | Quadratus Lumborum Block 2, Quadratus Lumborum Block 3 |
Primary outcome
Opioid consumption in the first 24 hours after surgery
Time frame: 1 day
Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA). Patients will be able to request opioids via PCA device when the nrs score is above 4.
1 secondary outcome
Post-operative acute pain
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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.
ERSİN KÖKSAL, MD study director
Ondokuz Mayıs University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia in people with Analgesia and Acute Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 9 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: finished, as of the sponsor's last update on 19 Apr 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption in the first 24 hours after surgery (time frame: 1 day). 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 19 Apr 2021.