AnalgesiaPhase 4NCT04496193
The Effects of Adding Dexamethasone in the Quadratus Lumborum Block
A Phase 4 study testing Quadratus Lumborum block in people with Analgesia and Motor Activity, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
The quadratus lumborum block is widely used in abdominal surgery for post-operative analgesia. It is now also used for pain relief after hip surgery. Under the traditional blocking method, a high concentration of long-acting local anesthetic is used in order to achieve a long-term blocking effect. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Analgesia, Motor Activity
- What is being tested?
- Quadratus Lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2020to 31 Dec 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification: I ~ III
- Patients who received quadratus lumborum block for post-hip surgery analgesia
Who cannot join
- Lumbar plexus degeneration,
- Coagulation abnormalities with international normalized ratio (INR) > 1.5
- Obvious heart, lung, liver or kidney disease
- Body mass index less than 18.5 or greater than 35
- Pregnancy
- Regular use of steroids or opiates Opioids
- Chronic medication or alcohol abuse
- Previous allergies or adverse reactions to opiates, dexamethasone, or ropivacaine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing the Effects of Adding Dexamethasone in 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Quadratus Lumborum Block
The quadratus lumborum block is widely used in abdominal surgery for post-operative analgesia. It is now also used for pain relief after hip surgery. Under the traditional blocking method, a high concentration of long-acting local anesthetic is used in order to achieve a long-term blocking effect. However, this is also likely to cause the patient's quadriceps weakness during the block period, increasing the risk of the patient falling during rehabilitation. It also increases systemic local anesthetic poisoning and may even trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia.
Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local anesthetics in peripheral nerve block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently.
In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the quadratus lumborum block, reducing the local anesthetic concentration is a feasible method. However, this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low concentrations and Ropivacaine (0.5%) alone.
Read the detailed description
Test drug:
- Name: Dexamethasone sod. Phosphate
- Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp
- Dose(s): 4mg
- Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL
- Mechanism of action: Synthesis of adrenocortical hormones, has a strong anti-inflammatory effect, can prolong the effect of local anesthetic drugs
- Pharmacological category: HS051 Glucocorticoids
Study design:
- ☑ Control: ☑ placebo（N/S 0.8 mL + 0.25% Ropivacaine 20 mL）
- active (Dexamethasone 4mg＋0.25% Ropivacaine 20 mL)
- others（N/S 0.8 mL + 0. 5% Ropivacaine 20 mL） □ Uncontrolled 2. Blinding: □ open-label □ single blind ☑ double blind □ others 3. Randomized: ☑ yes □ no 4. ☑ Parallel □ cross-over □ others 5. Duration of study：from Institutional Review Board (IRB) approval ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of treatment：from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months
- Multi-national □multi-center(Taiwan) ☑single center(Taiwan) 6. Number of subjects: 90 7. Is there any of the followings included Data Safety and Monitoring Board (DSMB)
- yes ☑ no
Assessment criteria:
- Efficacy:
- The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to quantify their degree of pain; where 0 means no pain and 10 the worst pain imaginable.
- The analgesic activity was assessed using standard measures during the 48-hour treatment period: baseline pain intensity, time to rescue medication, and overall patient evaluation of study medication.
- Safety:
- Record the hemodynamic parameters during the 60-minute observation period in the anesthesia recovery room.
- The severity of postoperative side effects (nausea, vomiting, pruritus) was quantified using different scales. Other side effects, including dizziness and drowsiness, are also recorded.
- Motor block is assessed using Modified Bromage Scale.
- Pharmacokinetics: None
- Quality of life:
- analgesic activity and duration of action
- patient satisfaction
- Conditions
- Analgesia, Motor Activity
- Being tested
- Quadratus Lumborum block
- Medical subject headings
- Agnosia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum blockProcedure or surgery
Quadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves.
| Study group | Role | What they receive |
|---|---|---|
| Group lower dose ropivacaine with dexamethasone | Experimental | Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + dexamethasone 0.8 ml (4mg) at the end of surgery Receives: Procedure: Quadratus Lumborum block |
| Group higher dose ropivacaine with N/S | Active comparator | Quadratus lumborum block was administered with 0.5% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery Receives: Procedure: Quadratus Lumborum block |
| Group lower dose ropivacaine with N/S | Placebo comparator | Quadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery Receives: Procedure: Quadratus Lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the post-operative analgesic effect of quadratus lumborum block
- The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS)
- In an hour in the recovery room, the pain will be evaluated every 15 minutes.
- Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start31 Jul 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Te Hsu, MD, PhD, Principal investigator, Department of Anesthesiology, Kaohsiung Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496193
- Sponsor's protocol ID
- KMUHIRB-F(I)-20200099
- Status last verified
- Jun 2020
- First submitted
- 27 Jul 2020
- Last updated
- 4 Aug 2020
- 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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Adding Dexamethasone in 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Quadratus Lumborum Block
- ClinicalTrials.gov ID
- NCT04496193
- Acronym / sponsor ID
- KMUHIRB-F(I)-20200099
- Conditions
- Analgesia, Motor Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Aug 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.
The quadratus lumborum block is widely used in abdominal surgery for post-operative analgesia. It is now also used for pain relief after hip surgery. Under the traditional blocking method, a high concentration of long-acting local anesthetic is used in order to achieve a long-term blocking effect. However, this is also likely to cause the patient's quadriceps weakness during the block period, increasing the risk of the patient falling during rehabilitation. It also increases systemic local anesthetic poisoning and may even trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia.
Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local anesthetics in peripheral nerve block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently.
In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the quadratus lumborum block, reducing the local anesthetic concentration is a feasible method. However, this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low concentrations and Ropivacaine (0.5%) alone.
Detailed description
Test drug:
- Name: Dexamethasone sod. Phosphate
- Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp
- Dose(s): 4mg
- Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL
- Mechanism of action: Synthesis of adrenocortical hormones, has a strong anti-inflammatory effect, can prolong the effect of local anesthetic drugs
- Pharmacological category: HS051 Glucocorticoids
Study design:
- ☑ Control: ☑ placebo（N/S 0.8 mL + 0.25% Ropivacaine 20 mL）
- active (Dexamethasone 4mg＋0.25% Ropivacaine 20 mL)
- others（N/S 0.8 mL + 0. 5% Ropivacaine 20 mL） □ Uncontrolled 2. Blinding: □ open-label □ single blind ☑ double blind □ others 3. Randomized: ☑ yes □ no 4. ☑ Parallel □ cross-over □ others 5. Duration of study：from Institutional Review Board (IRB) approval ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of treatment：from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months
- Multi-national □multi-center(Taiwan) ☑single center(Taiwan) 6. Number of subjects: 90 7. Is there any of the followings included Data Safety and Monitoring Board (DSMB)
- yes ☑ no
Assessment criteria:
- Efficacy:
- The intensity of pain was assessed using a 0 to 10 Numerical Rating Scale (NRS) to quantify their degree of pain; where 0 means no pain and 10 the worst pain imaginable.
- The analgesic activity was assessed using standard measures during the 48-hour treatment period: baseline pain intensity, time to rescue medication, and overall patient evaluation of study medication.
- Safety:
- Record the hemodynamic parameters during the 60-minute observation period in the anesthesia recovery room.
- The severity of postoperative side effects (nausea, vomiting, pruritus) was quantified using different scales. Other side effects, including dizziness and drowsiness, are also recorded.
- Motor block is assessed using Modified Bromage Scale.
- Pharmacokinetics: None
- Quality of life:
- analgesic activity and duration of action
- patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group lower dose ropivacaine with dexamethasone | Experimental | Procedure: Quadratus Lumborum blockQuadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + dexamethasone 0.8 ml (4mg) at the end of surgery |
| Group higher dose ropivacaine with N/S | Active comparator | Procedure: Quadratus Lumborum blockQuadratus lumborum block was administered with 0.5% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery |
| Group lower dose ropivacaine with N/S | Placebo comparator | Procedure: Quadratus Lumborum blockQuadratus lumborum block was administered with 0.25% Ropivacaine 20 ml + N/S 0.8 ml at the end of surgery |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification: I ~ III
- Patients who received quadratus lumborum block for post-hip surgery analgesia
Key exclusion criteria (8 listed)
- Lumbar plexus degeneration,
- Coagulation abnormalities with international normalized ratio (INR) > 1.5
- Obvious heart, lung, liver or kidney disease
- Body mass index less than 18.5 or greater than 35
- Pregnancy
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 blockQuadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves. | Procedure or surgery | Group higher dose ropivacaine with N/S, Group lower dose ropivacaine with N/S, Group lower dose ropivacaine with dexamethasone |
Primary outcome
the post-operative analgesic effect of quadratus lumborum block
Time frame: Within 48 hours after surgery
1. The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS) 2. In an hour in the recovery room, the pain will be evaluated every 15 minutes. 3. Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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.
Hung-Te Hsu, MD, PhD principal investigator
Department of Anesthesiology, Kaohsiung Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadratus Lumborum block in people with Analgesia and Motor Activity, run by Kaohsiung Medical University Chung-Ho Memorial 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 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 4 Aug 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hung-Te Hsu, MD, PhD (+88673121101 ext. 7033, hdhsu1228@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the post-operative analgesic effect of quadratus lumborum block (time frame: Within 48 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 4 Aug 2020.