Laparoscopic Renal SurgeryNCT03982784
TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
A study testing single-injection TQLB(transmuscular quadratus lumborum block) in people with Laparoscopic Renal Surgery and Pain Management, run by Cui Xulei at 1 site in China.
Trial summary
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone… Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Laparoscopic Renal Surgery, Pain Management, Nerve Block
- What is being tested?
- single-injection TQLB(transmuscular quadratus lumborum block)
- 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
- 1 siteChina
- Study dates
- 10 Jun 2019to 10 Nov 2019
- 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic partial nephrectomy
- Informed consent
Who cannot join
- A known allergy to the drugs being used
- Coagulopathy, on anticoagulants
- Analgesics intake, history of substance abuse
- Participating in the investigation of another experimental agent
- Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic partial nephrectomy.
- Conditions
- Laparoscopic Renal Surgery, Pain Management, Nerve Block
- Being tested
- single-injection TQLB(transmuscular quadratus lumborum block), Morphine given as IPCA(intravenous patient controlled analgesia)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-injection TQLB(transmuscular quadratus lumborum block)Procedure or surgery
Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance
Morphine given as IPCA(intravenous patient controlled analgesia)Drug
PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.
| Study group | Role | What they receive |
|---|---|---|
| single-injection TQLB(transmuscular quadratus lumborum block) | Experimental | Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia) Receives: Procedure: single-injection TQLB(transmuscular quadratus lumborum block); Drug: Morphine given as IPCA(intravenous patient controlled analgesia) |
| Control | Active comparator | postoperative IPCA is given alone Receives: Drug: Morphine given as IPCA(intravenous patient controlled analgesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative morphine consumption 8 hours after surgery
Measured: at the 8 hours after surgery
Secondary outcomes (8)
cumulative morphine consumption at other time points after surgery
Measured: at 0, 2, 4, 12, 24 and 48 hours after surgery
The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10)
NRS is an internationally recognized pain scale with 11 points ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable.
Measured: at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery
episodes of nausea and vomiting
Measured: within 24 hours after the surgery
ambulation time
time from the end of the surgery to the first time to out-of-bed activity
Measured: within the 5 days after surgery
time of recovery of bowl movement
time from the end of the surgery to the first time of bowl movement
Measured: within the 5 days after surgery
patient satisfaction with anesthesia
Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
Measured: at 48 hours after surgery
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
QoR is a 15-item questionnaire which will score on a scale of 0-10 pertaining to patient's comfort, support system, pain, well-being, and ability to carry out daily activities, where 0 indicates none of the time and 10 indicates all of the time
Measured: at 72 hours and 120 hours after the sugery
postoperative length of hospital stay
time to patient's discharge
Measured: within 2 weeks after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start10 Jun 2019
- Primary completion1 Nov 2019
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Renal SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cui Xulei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Xulei, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982784
- Sponsor's protocol ID
- cxl2
- Status last verified
- Nov 2019
- First submitted
- 4 Jun 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03982784
- Acronym / sponsor ID
- cxl2
- Conditions
- Laparoscopic Renal Surgery, Pain Management, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 12 Jun 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 prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic partial nephrectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-injection TQLB(transmuscular quadratus lumborum block) | Experimental | Procedure: single-injection TQLB(transmuscular quadratus lumborum block), Drug: Morphine given as IPCA(intravenous patient controlled analgesia)Single-injection of TQLB is given preoperatively + postoperative IPCA(intravenous patient controlled analgesia) |
| Control | Active comparator | Drug: Morphine given as IPCA(intravenous patient controlled analgesia)postoperative IPCA is given alone |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic partial nephrectomy
- Informed consent
Key exclusion criteria (5 listed)
- A known allergy to the drugs being used
- Coagulopathy, on anticoagulants
- Analgesics intake, history of substance abuse
- Participating in the investigation of another experimental agent
- Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
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 |
|---|---|---|
| single-injection TQLB(transmuscular quadratus lumborum block)Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance | Procedure or surgery | single-injection TQLB(transmuscular quadratus lumborum block) |
| Morphine given as IPCA(intravenous patient controlled analgesia)PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h. | Drug | Control, single-injection TQLB(transmuscular quadratus lumborum block) |
Primary outcome
cumulative morphine consumption 8 hours after surgery
Time frame: at the 8 hours after surgery
8 secondary outcomes
cumulative morphine consumption at other time points after surgery
Time frame: at 0, 2, 4, 12, 24 and 48 hours after surgery
The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10)
Time frame: at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery
episodes of nausea and vomiting
Time frame: within 24 hours after the surgery
ambulation time
Time frame: within the 5 days after surgery
time of recovery of bowl movement
Time frame: within the 5 days after surgery
patient satisfaction with anesthesia
Time frame: at 48 hours after surgery
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
Time frame: at 72 hours and 120 hours after the sugery
postoperative length of hospital stay
Time frame: within 2 weeks after the 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 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Laparoscopic Renal Surgery
Recruiting
Comparison of Transversus Abdominis Plane and Erector Spinae Plane Blocks for Pain Control After Renal Laparoscopy
Postoperative Pain, Acute
Not yet recruitingObservational study
Early Kidney Injury Biomarkers in Gynecologic Laparoscopic Surgery
Acute Kidney Injury, Subclinical Acute Kidney Injury
RecruitingObservational study
Assessment of Renal Perfusion Using Ultrasound and Near-Infrared Spectroscopy in Patients Undergoing Minimally Invasive Abdominal Surgery
Renal Perfusion, Minimally Invasive Surgical Procedures
Recruiting
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
Renal Cell Cancer
Not yet recruiting
A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.
Kidney Neoplasms / Surgery, Robotic Surgical Procedures
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 single-injection TQLB(transmuscular quadratus lumborum block) in people with Laparoscopic Renal Surgery and Pain Management, run by Cui Xulei at 1 site in China.
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 4 inclusion and 5 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 13 Nov 2019. 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 China. 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?
cumulative morphine consumption 8 hours after surgery (time frame: at the 8 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 13 Nov 2019.