AnalgesiaNCT04143542
Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery
A study testing trunk blocks in people with Analgesia and Block, run by Diskapi Teaching and Research Hospital.
Trial summary
This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- trunk blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2020to 5 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal surgery
Who cannot join
- Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
Read the detailed description
This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery.
In abdominal surgeries, USG guided body blocks are performed for postoperative analgesia. For this purpose, Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks.
The aim of this study was to evaluate for postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.
- Being tested
- trunk blocks
- Keywords
- quadratus lumborum block, transversus abdominis block, postoperative analgesia
- Medical subject headings
- Agnosia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trunk blocksProcedure or surgery
Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery
| Study group | Role | What they receive |
|---|---|---|
| Groups Q | Experimental | In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks.
The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward. Receives: Procedure: trunk blocks |
| Groups T | Experimental | In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks.
The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward. Receives: Procedure: trunk blocks |
| Groups C | No intervention | There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 1 hours
Postoperative pain
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 2 hours
Postoperative pain
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 4 hours
The degree of postoperative pain
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start23 Apr 2020 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion5 May 2020 (estimated)
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital
- Investigators
- Ceyda Ozhan Caparlar, Study director, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143542
- Sponsor's protocol ID
- QLB 2
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2019
- Last updated
- 24 Apr 2020
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04143542
- Acronym / sponsor ID
- QLB 2
- Keywords
- quadratus lumborum block, transversus abdominis block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 23 Apr 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 5 May 2020 (estimated)
- First posted
- 29 Oct 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 to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery
Detailed description
This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery.
In abdominal surgeries, USG guided body blocks are performed for postoperative analgesia. For this purpose, Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks.
The aim of this study was to evaluate for postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groups Q | Experimental | Procedure: trunk blocksIn abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward. |
| Groups T | Experimental | Procedure: trunk blocksIn abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward. |
| Groups C | No intervention | –There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abdominal surgery
Key exclusion criteria (1 listed)
- Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy
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 |
|---|---|---|
| trunk blocksComparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery | Procedure or surgery | Groups Q, Groups T |
Primary outcome
Postoperative pain
Time frame: 1 hours
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Postoperative pain
Time frame: 2 hours
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Postoperative pain
Time frame: 4 hours
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
The degree of postoperative pain
Time frame: 24 hours
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Ceyda Ozhan Caparlar study director
Diskapi Yildirim Beyazit Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing trunk blocks in people with Analgesia and Block, run by Diskapi Teaching and Research Hospital.
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 1 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 24 Apr 2020. 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. 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 Ceyda Ozhan Caparlar, MD (+905052919489, mdceydacaparlar@yahoo.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: 1 hours). The study lists 4 primary outcomes in all. 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 24 Apr 2020.