AnalgesiaNCT06129032
Comparing QLB Type I Block to Intraperitoneal Instillation Added to Wound Infiltration for Postoperative Cesarian Pain
A study testing Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation and Group QUADRATUS LUMBORUM BLOCK (QLB) in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation and Group QUADRATUS LUMBORUM BLOCK (QLB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 25 Jun 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 18 to 50
- American Society of Anesthesiologists (ASA) II classification,
- full-term and singleton pregnancies planned to undergo cesarean section
- using Pfannenstiel incision
- spinal anaesthesia
Who cannot join
- whom neuraxial anaesthesia is contraindicated,
- those who are allergic to drugs to be used in the study,
- who refused to participate in the study,
- those with BMI>35 kg/m2,
- ASA score ≥3 or higher,
- diabetes mellitus, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain,
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- individuals who have received opioids during the surgical procedure for intraoperative pain,
- patients who have undergone abdominal surgery,
- patients who have experienced a transition from spinal anaesthesia to general anaesthesia due to failure,
- those with excessive bleeding during the operation,
- who have uterine atony,
- those who have a drain placed in the area to be infiltrated,
- those who cannot understand the Visual Analog Scale (VAS),
- who have a history of drug addiction and psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Ayşenur Dostbil contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk University
Erzurum
Ayşenur Dostbil
About this study
Official title: Comparing Quadratus Lumborum Type 1 Block to The Combination Of Intraperitoneal Instillation Of Local Anesthetics And Wound Infiltration For Postoperative Pain After Cesarean Delivery: A Prospective Double-Blind Randomized Controlled Study
This study aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.
Read the detailed description
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.
- Conditions
- Analgesia
- Being tested
- Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation, Group QUADRATUS LUMBORUM BLOCK (QLB)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillationProcedure or surgery
a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia.
A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision
Group QUADRATUS LUMBORUM BLOCK (QLB)Procedure or surgery
quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Group Wound infiltration + Intraperitoneal local anaesthetic instillation | Active comparator | the surgeon will be given a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia. A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours. Receives: Procedure: Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation |
| Group QUADRATUS LUMBORUM BLOCK | Active comparator | In the QLB group, quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours. Receives: Procedure: Group QUADRATUS LUMBORUM BLOCK (QLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between total opioid consumption in 24 hours
The study will involve monitoring the intake of opioids at specific time intervals (2nd, 4th, 6th, 12th, and 24th hours), calculating the cumulative opioid consumption until the 24th hour
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- Ayşenur Dostbil, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129032
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/462
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
PubMed 26996986Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Quadratus Lumborum Type 1 Block to The Combination Of Intraperitoneal Instillation Of Local Anesthetics And Wound Infiltration For Postoperative Pain After Cesarean Delivery: A Prospective Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06129032
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/462
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 13 Nov 2023 (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 aimed to compare the efficacy of local anaesthetic infiltration into all layers of the anterior abdominal wall with peritoneal instillation and QLB type I for pain reduction in women undergoing elective cesarean section under spinal anaesthesia.
Detailed description
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 18 to 50 with American Society of Anesthesiologists (ASA) II classification, full-term and singleton pregnancies planned to undergo cesarean section using Pfannenstiel incision with spinal anaesthesia. Using a randomisation procedure, the participants will be allocated into two equal groups: Group IPLA+ LWI and Group QLB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Wound infiltration + Intraperitoneal local anaesthetic instillation | Active comparator | Procedure: Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillationthe surgeon will be given a solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia. A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours. |
| Group QUADRATUS LUMBORUM BLOCK | Active comparator | Procedure: Group QUADRATUS LUMBORUM BLOCK (QLB)In the QLB group, quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance. Patients will receive 800mg of ibuprofen and 1g of paracetamol 30 minutes prior to the end of the procedure. Following the surgical procedure, each patient will get a dosage of 15 mg/kg paracetamol every 6 hours and 800 mg of ibuprofen every 8 hours for 24 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 18 to 50
- American Society of Anesthesiologists (ASA) II classification,
- full-term and singleton pregnancies planned to undergo cesarean section
- using Pfannenstiel incision
- spinal anaesthesia
Key exclusion criteria (14 listed)
- whom neuraxial anaesthesia is contraindicated,
- those who are allergic to drugs to be used in the study,
- who refused to participate in the study,
- those with BMI>35 kg/m2,
- ASA score ≥3 or higher,
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 |
|---|---|---|
| Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillationa solution containing 20 ml of 0.5% bupivacaine, 20 ml of 2% lidocaine and 1:200,000 epinephrine with a total volume of 40 ml. A volume of 10 millilitres of the solution will be administered through the drip technique into each of the four quadrants of the uterus prior to the subsequent closure of the parietal peritoneum or fascia. A total volume of 10 ml of the solution will be administered through infiltration at the edges of the rectus aponeurosis, while the remaining 20 ml will be infiltrated subcutaneously into the incision | Procedure or surgery | Group Wound infiltration + Intraperitoneal local anaesthetic instillation |
| Group QUADRATUS LUMBORUM BLOCK (QLB)quadratus lumborum type 1 block will be applied bilaterally on both sides with a total of 40 ml of solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200.000 epinephrine, under ultrasound guidance | Procedure or surgery | Group QUADRATUS LUMBORUM BLOCK |
Primary outcome
difference between total opioid consumption in 24 hours
Time frame: postoperative 24 hours
The study will involve monitoring the intake of opioids at specific time intervals (2nd, 4th, 6th, 12th, and 24th hours), calculating the cumulative opioid consumption until the 24th hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 26996986Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
- Background: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
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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.
Ayşenur Dostbil contact
Ayşenur Dostbil study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound infiltration (LWI) + Intraperitoneal local anaesthetic (IPLA) instillation and Group QUADRATUS LUMBORUM BLOCK (QLB) in people with Analgesia, run by Ataturk 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 5 inclusion and 14 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 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Dostbil (+905333677796, adostbil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference between total opioid consumption in 24 hours (time frame: postoperative 24 hours). 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 NCT06129032, which also lists 2 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 14 Nov 2023.