Nephrostomy; ComplicationsPhase 4QLBNCT02121951
Quadratus Lumborum Block for Percutaneous Nephrostomy
A Phase 4 study testing Local Anesthetic infiltration, Quadratus Lumborum block and MAC in people with Nephrostomy; Complications and Upper Urinary Tract Dilatation and Obstruction, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrostomy; Complications, Upper Urinary Tract Dilatation and Obstruction, Regional Anesthesia Morbidity
- What is being tested?
- Local Anesthetic infiltration, Quadratus Lumborum block and MAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Aug 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA grade III and IV patients,
- Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy
Who cannot join
- Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.
- Untreated urinary tract infection;
- Pre-operative haemoglobin <10 gm/dl,
- Severely co morbid patients
- Non-dilated renal collecting system
- Patient refusal to consent for the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy
Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.
Read the detailed description
Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\analgesia to a minimum.
- Conditions
- Nephrostomy; Complications, Upper Urinary Tract Dilatation and Obstruction, Regional Anesthesia Morbidity, Adverse Anesthesia Outcome
- Being tested
- Local Anesthetic infiltration, Quadratus Lumborum block, MAC
- Keywords
- Percutaneous Nephrostomy, Quadtatus Lumborum Block, Cancer, Monitored Anaesthesia Care
- Medical subject headings
- Bites and Stings, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Anesthetic infiltrationProcedure or surgery
Also called Lignocaine
Lignocaine infiltration through the nephrostomy track
Quadratus Lumborum blockProcedure or surgery
Also called -0.25% levobupivacaine (Chirocaine, Abbott, Ireland), -1% lignocaine
A linear 12-MHz ultrasound probe will be placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this point the layers of abdominal layers starte to taper. The probe will be placed in the posterior axillary line, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL will be noticed. At the posterior border of the quadratus lumborum muscle and outside the fascia, Touhe needle will be inserted in plane and confirmed its position by injecting saline. Under ultrasound (US) guidance, local anesthetic mixure will be deposited separating the fascia
MACDrug
Also called -Midazolam: 1 mg\ml, -Fentanyl: 10 mic\ml
Incremental doses are given to the targed sedation and analgesia
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetic infiltration and MAC | Active comparator | * Local Anesthetic infiltration with 1% lignocaine
* MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml Receives: Procedure: Local Anesthetic infiltration; Drug: MAC |
| Quadratus Lumborum block and MAC | Experimental | * QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine
* MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml Receives: Procedure: Quadratus Lumborum block; Drug: MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia
Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.
Measured: 4 hours
Secondary outcomes (4)
Respiratory Depression
Respiratory rate and airway patency is monitored with an anesthesiologist.
Measured: 4 hours
Sedation
Ramsay Seadation Score is assessed during and after procedure till discharge
Measured: 4 hours
Cardiovascular stability
Blood pressure and Heart rate is assessed during and after procedure till discharge
Measured: 4 hours
Patient Satisfaction
Patient Satisfaction Quistionaire
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionAug 2014
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 Nephrostomy; ComplicationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M N Bashandy, National Cancer Institute, Egypt
- Investigators
- Dina N Abbas, M D, Study director, National Cancer Institute, EgyptGhada M Bashandy, MD, Principal investigator, National Cancer Institute, EgyptWael Darwish, M D, Study chair, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121951
- Sponsor's protocol ID
- Quadratus Lumborum Block
- Acronym
- QLB
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.
PubMed 24310051
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy
- ClinicalTrials.gov ID
- NCT02121951
- Acronym / sponsor ID
- QLB / Quadratus Lumborum Block
- Conditions
- Nephrostomy; Complications, Upper Urinary Tract Dilatation and Obstruction, Regional Anesthesia Morbidity, Adverse Anesthesia Outcome
- Keywords
- Percutaneous Nephrostomy, Quadtatus Lumborum Block, Cancer, Monitored Anaesthesia Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Apr 2014 (estimated)
- 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 nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.
Detailed description
Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\analgesia to a minimum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic infiltration and MAC | Active comparator | Procedure: Local Anesthetic infiltration, Drug: MAC* Local Anesthetic infiltration with 1% lignocaine * MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml |
| Quadratus Lumborum block and MAC | Experimental | Procedure: Quadratus Lumborum block, Drug: MAC* QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine * MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA grade III and IV patients,
- Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy
Key exclusion criteria (6 listed)
- Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.
- Untreated urinary tract infection;
- Pre-operative haemoglobin <10 gm/dl,
- Severely co morbid patients
- Non-dilated renal collecting system
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 |
|---|---|---|
| Local Anesthetic infiltrationAlso: LignocaineLignocaine infiltration through the nephrostomy track | Procedure or surgery | Local Anesthetic infiltration and MAC |
| Quadratus Lumborum blockAlso: -0.25% levobupivacaine (Chirocaine, Abbott, Ireland), -1% lignocaineA linear 12-MHz ultrasound probe will be placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this point the layers of abdominal layers starte to taper. The probe will be placed in the posterior axillary line, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL will be noticed. At the posterior border of the quadratus lumborum muscle and outside the fascia, Touhe needle will be inserted in plane and confirmed its position by injecting saline. Under ultrasound (US) guidance, local anesthetic mixure will be deposited separating the fascia | Procedure or surgery | Quadratus Lumborum block and MAC |
| MACAlso: -Midazolam: 1 mg\ml, -Fentanyl: 10 mic\mlIncremental doses are given to the targed sedation and analgesia | Drug | Local Anesthetic infiltration and MAC, Quadratus Lumborum block and MAC |
Primary outcome
Analgesia
Time frame: 4 hours
Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.
4 secondary outcomes
Respiratory Depression
Time frame: 4 hours
Sedation
Time frame: 4 hours
Cardiovascular stability
Time frame: 4 hours
Patient Satisfaction
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Results publication: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Results publication: PubMed 24310051Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.
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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.
Dina N Abbas, M D study director
National Cancer Institute, Egypt
Ghada M Bashandy, MD principal investigator
National Cancer Institute, Egypt
Wael Darwish, M D study chair
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local Anesthetic infiltration, Quadratus Lumborum block and MAC in people with Nephrostomy; Complications and Upper Urinary Tract Dilatation and Obstruction, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 6 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: withdrawn, as of the sponsor's last update on 10 Apr 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 Egypt. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Analgesia (time frame: 4 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 NCT02121951, 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 10 Apr 2018.