Pain ManagementNCT03844477
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
A study testing single-injection QLB(quadratus lumborum block) in people with Pain Management and Nerve Block, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Nerve Block, Laparoscopic Adrenalectomy
- What is being tested?
- single-injection QLB(quadratus lumborum block)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2019to 15 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic adrenalectomy
- 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
This prospective, randomized ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.
- Conditions
- Pain Management, Nerve Block, Laparoscopic Adrenalectomy
- Being tested
- single-injection QLB(quadratus lumborum block), Placebo control
- 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 QLB(quadratus lumborum block)Procedure or surgery
Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion
Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan
Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified.
Placebo controlProcedure or surgery
Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion
Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan
Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified.
| Study group | Role | What they receive |
|---|---|---|
| single-injection QLB(quadratus lumborum block) | Experimental | Single-injection of QLB with local anesthetic is given preoperatively Receives: Procedure: single-injection QLB(quadratus lumborum block) |
| Placebo control | Placebo comparator | Single-injection of QLB with NS is given preoperatively Receives: Procedure: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery
Measured: At 12hours after the surgery
Secondary outcomes (7)
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Measured: At 2,4, 8, 12,24 ,48,72hours after the surgery
incidence of postoperative nausea and vomiting (PONV)
Measured: within 24 postoperative hours
ambulation time
Measured: within5 days after surgery
time of restart anal exhaust
Measured: within 5 days after surgery
Postoperative length of hospital stay
Measured: up to2 weeks after surgery
patient's satisfaction with anesthesia and analgesia
use the Chinese version Bauer questionnaire to assess the patient satisfaction with anesthesia and analgesia
Measured: 48 hours after surgery
The pain scores at activity determined by the numeric rating scale (NRS, 0-10)
Measured: At 2,4, 8, 24 ,48,72hours 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 posted18 Feb 2019
- Study start16 Feb 2019
- Primary completion1 May 2019
- Study completion15 May 2019
Why it stopped: We change the study protocal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
- Investigators
- Xulei CUI, md, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844477
- Sponsor's protocol ID
- cuixulei6
- Status last verified
- Sep 2019
- First submitted
- 15 Feb 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
- ClinicalTrials.gov ID
- NCT03844477
- Acronym / sponsor ID
- cuixulei6
- Conditions
- Pain Management, Nerve Block, Laparoscopic Adrenalectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We change the study protocal
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 18 Feb 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 ,control study aims to compare the analgesic effect,quality of recovery, length of hospital stay ,et al. between single-injection QLB(quadratus lumborum block)+general anesthesia (GA) and general anesthesia (GA) alone in patients undergoing laparoscopic adrenalectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-injection QLB(quadratus lumborum block) | Experimental | Procedure: single-injection QLB(quadratus lumborum block)Single-injection of QLB with local anesthetic is given preoperatively |
| Placebo control | Placebo comparator | Procedure: Placebo controlSingle-injection of QLB with NS is given preoperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic adrenalectomy
- 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 QLB(quadratus lumborum block)Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified. | Procedure or surgery | single-injection QLB(quadratus lumborum block) |
| Placebo controlInject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified. | Procedure or surgery | Placebo control |
Primary outcome
pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery
Time frame: At 12hours after the surgery
7 secondary outcomes
The pain scores at rest determined by the numeric rating scale (NRS, 0-10)
Time frame: At 2,4, 8, 12,24 ,48,72hours after the surgery
incidence of postoperative nausea and vomiting (PONV)
Time frame: within 24 postoperative hours
ambulation time
Time frame: within5 days after surgery
time of restart anal exhaust
Time frame: within 5 days after surgery
Postoperative length of hospital stay
Time frame: up to2 weeks after surgery
patient's satisfaction with anesthesia and analgesia
Time frame: 48 hours after surgery
The pain scores at activity determined by the numeric rating scale (NRS, 0-10)
Time frame: At 2,4, 8, 24 ,48,72hours after the surgery
Results and safety
The study was stopped early (reason given: We change the study protocal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Xulei CUI, md principal investigator
Peking Union Medical College 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 single-injection QLB(quadratus lumborum block) in people with Pain Management and Nerve Block, run by Peking Union Medical College Hospital 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: stopped early, as of the sponsor's last update on 4 Sep 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. 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 was stopped early (reason given: We change the study protocal). Results are not available in the source record.
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?
pain numeric rating scale (NRS, 0-10)pain score at activity at 12 hours after surgery (time frame: At 12hours after the 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 Sep 2019.