Open Nephrectomy SurgeryQL AnalgesiaNCT03110081
Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery
A study testing Quadratus lumborum block and Epidural analgesia in people with Open Nephrectomy Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Nephrectomy Surgery
- What is being tested?
- Quadratus lumborum block and Epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 14 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults having for open unilateral partial nephrectomy surgery.
Who cannot join
- 1. Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.
Read the detailed description
QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.
Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.
- Conditions
- Open Nephrectomy Surgery
- Being tested
- Quadratus lumborum block, Epidural analgesia
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 (QL) block for open partial nephrectomy.
Epidural analgesiaProcedure or surgery
Epidural analgesia for open partial nephrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Experimental | Quadratus lumborum (QL) block group will receive a single shot injection of 25 ml 0.25% bupivacaine pre-operatively, followed post-operatively by infusion of ropivacaine 0.2% continuously administered via the QL catheter for at least 48 hours. Receives: Procedure: Quadratus lumborum block |
| Epidural analgesia | Active comparator | Midthoracic catheters will be inserted preoperatively. A bupivacaine 0.1% infusion will be started before the surgical incision, and continuously administered for at least 48 hr at an infusion rate of 5 ml/hr. Receives: Procedure: Epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.
Measured: Arrival to post anesthesia care unit until 72 hours after surgery
Postoperative pain
Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores.
Measured: Arrival to post anesthesia care unit until 72 hours after surgery
Secondary outcomes (4)
Patient Global Assessment
Patient global assessment of pain control is measured on an ordinal scale by the patient. Patients can rate their pain control as poor, fair, good, or excellent.
Measured: Three days after surgery
Doses of antiemetic medications administered
Count of the number of antiemetic medications administered.
Measured: Arrival to post anesthesia care unit until the third day after surgery
Duration of postoperative hospitalization
Duration of postoperative hospitalization
Measured: From the date of surgery to hospital discharge, assessed up to 12 months.
Episodes of hypotension
Number of episodes of hypotension during hospital stay, defined by MAP less than 65 mmHg requiring intervention.
Measured: Arrival to post anesthesia care unit until the third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2018
- Primary completion14 Sep 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Nephrectomy SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110081
- Sponsor's protocol ID
- 15-1291
- Acronym
- QL Analgesia
- Status last verified
- Apr 2021
- First submitted
- 21 Mar 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.
PubMed 33617181
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery
- ClinicalTrials.gov ID
- NCT03110081
- Acronym / sponsor ID
- QL Analgesia / 15-1291
- Conditions
- Open Nephrectomy Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 12 Apr 2017 (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 assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.
Detailed description
QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.
Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Experimental | Procedure: Quadratus lumborum blockQuadratus lumborum (QL) block group will receive a single shot injection of 25 ml 0.25% bupivacaine pre-operatively, followed post-operatively by infusion of ropivacaine 0.2% continuously administered via the QL catheter for at least 48 hours. |
| Epidural analgesia | Active comparator | Procedure: Epidural analgesiaMidthoracic catheters will be inserted preoperatively. A bupivacaine 0.1% infusion will be started before the surgical incision, and continuously administered for at least 48 hr at an infusion rate of 5 ml/hr. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults having for open unilateral partial nephrectomy surgery.
Key exclusion criteria (1 listed)
- 1. Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-
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 (QL) block for open partial nephrectomy. | Procedure or surgery | Quadratus lumborum block |
| Epidural analgesiaEpidural analgesia for open partial nephrectomy. | Procedure or surgery | Epidural analgesia |
Primary outcome
Total opioid consumption
Time frame: Arrival to post anesthesia care unit until 72 hours after surgery
Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.
Postoperative pain
Time frame: Arrival to post anesthesia care unit until 72 hours after surgery
Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores.
4 secondary outcomes
Patient Global Assessment
Time frame: Three days after surgery
Doses of antiemetic medications administered
Time frame: Arrival to post anesthesia care unit until the third day after surgery
Duration of postoperative hospitalization
Time frame: From the date of surgery to hospital discharge, assessed up to 12 months.
Episodes of hypotension
Time frame: Arrival to post anesthesia care unit until the third day after surgery
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 29 Apr 2021.
- Derived from this study: PubMed 33617181Elsharkawy H, Ahuja S, Sessler DI, Maheshwari K, Mao G, Sakr Esa WA, Soliman LM, Ayad S, Khoshknabi D, Khan MZ, Raza S, DeGrande S, Turan A. Subcostal Anterior Quadratus Lumborum Block Versus Epidural Block for Analgesia in Open Nephrectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Apr 1;132(4):1138-1145. doi: 10.1213/ANE.0000000000005382.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block and Epidural analgesia in people with Open Nephrectomy Surgery, run by The Cleveland Clinic at 1 site in United States.
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: finished, as of the sponsor's last update on 29 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 United States. 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?
Total opioid consumption (time frame: Arrival to post anesthesia care unit until 72 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT03110081, which also lists 1 linked publication.
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 29 Apr 2021.