Postoperative PainNCT03425162
Ultrasound Guided Anterior Quadratus Lumborum Block
A study testing Morphine Sulfate, Group P and Group A in people with Postoperative Pain and Ultrasound, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Pain, Ultrasound
- What is being tested?
- Morphine Sulfate, Group P and Group A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2018to 18 Aug 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy
Who cannot join
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
About this study
Official title: Ultrasound Guided Anterior Quadratus Lumborum Block for Postoperative Pain After Percutaneous Nephrolithotomy: Randomized Controlled Trial
Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime.
This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.
Read the detailed description
Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain.
In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.Analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .
- Conditions
- Postoperative Pain, Ultrasound
- Being tested
- Morphine Sulfate, Group P, Group A
- Keywords
- quadratus lumborum block, pain, ultrasound, percutaneous nephrolithotomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Morphine
patient-controlled analgesia (PCA) morphine
Group PProcedure or surgery
Group P:patient-controlled analgesia (PCA) morphine
Group AProcedure or surgery
Also called Bupivacaine
Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine) Receives: Drug: Morphine Sulfate; Procedure: Group A |
| Group P | Sham comparator | Group P:PCA (morphine) Receives: Drug: Morphine Sulfate; Procedure: Group P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)
Measured: Postoperative 24 hours
Secondary outcomes (3)
morphine consumption
morphine consumption
Measured: Postoperative 24 hours
side effect profile
side effect profile (Nausea and vomiting scale,Hypotension,Ramsay Sedation Scale)
- Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
- Hypotension
- Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap )
Measured: Postoperative 24 hours
additional analgesic use
additional analgesic use
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 posted7 Feb 2018
- Study start12 Feb 2018
- Primary completion18 Aug 2018
- Study completion18 Aug 2018
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.
- 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
- prospective,randomized,single blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, M.D, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425162
- Sponsor's protocol ID
- BYIEAH
- Status last verified
- Nov 2018
- First submitted
- 1 Feb 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Anterior Quadratus Lumborum Block for Postoperative Pain After Percutaneous Nephrolithotomy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03425162
- Acronym / sponsor ID
- BYIEAH
- Conditions
- Postoperative Pain, Ultrasound
- Keywords
- quadratus lumborum block, pain, ultrasound, percutaneous nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 18 Aug 2018 (actual)
- Study completion
- 18 Aug 2018 (actual)
- First posted
- 7 Feb 2018 (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.
Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime.
This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.
Detailed description
Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain.
In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.Analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective,randomized,single blind
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Morphine Sulfate, Procedure: Group AGroup A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine) |
| Group P | Sham comparator | Drug: Morphine Sulfate, Procedure: Group PGroup P:PCA (morphine) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy
Key exclusion criteria (3 listed)
- Previous history of opioid use preoperatively,
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 |
|---|---|---|
| Morphine SulfateAlso: Morphinepatient-controlled analgesia (PCA) morphine | Drug | Group A, Group P |
| Group PGroup P:patient-controlled analgesia (PCA) morphine | Procedure or surgery | Group P |
| Group AAlso: BupivacaineGroup A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine | Procedure or surgery | Group A |
Primary outcome
Visual Analog Scale
Time frame: Postoperative 24 hours
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)
3 secondary outcomes
morphine consumption
Time frame: Postoperative 24 hours
side effect profile
Time frame: Postoperative 24 hours
additional analgesic use
Time frame: Postoperative 24 hours
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 21 Nov 2018.
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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.
Korgün Ökmen, M.D principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate, Group P and Group A in people with Postoperative Pain and Ultrasound, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 1 inclusion and 3 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 21 Nov 2018. 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. 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?
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?
Visual Analog Scale (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?
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 21 Nov 2018.