Nerve Block, Nephrectomy, AnalgesiaNCT03414281
TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
A study testing TMQLB group 1, TMQLB group 2 and TPVB in people with Nerve Block, Nephrectomy, Analgesia, run by Cui Xulei at 1 site in China.
Trial summary
This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral… Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Nerve Block, Nephrectomy, Analgesia
- What is being tested?
- TMQLB group 1, TMQLB group 2 and TPVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2019to 1 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 17~80 years of age;
- American Society of Anesthesiologists physical status I-III;
- undergoing laparoscopic nephrectomy.
Who cannot join
- have a known allergy to the anesthetics being used;
- infection at injection site
- coagulopathy or history of anticoagulants use
- chronic analgesics consumption or history of substance abuse
- inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (TPVB).
- Conditions
- Nerve Block, Nephrectomy, Analgesia
- Being tested
- TMQLB group 1, TMQLB group 2, TPVB
- Keywords
- quadratus lumborum block, thoracic paravertebral block, nephrectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMQLB group 1Procedure or surgery
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
TMQLB group 2Procedure or surgery
The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
TPVBProcedure or surgery
The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10.
Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
| Study group | Role | What they receive |
|---|---|---|
| TMQLB group 1 | Experimental | 0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. Receives: Procedure: TMQLB group 1 |
| TMQLB group 2 | Experimental | 0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. Receives: Procedure: TMQLB group 2 |
| TPVB group | Active comparator | 0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach. Receives: Procedure: TPVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean VAS of the first postoperative 24 hours
VAS 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. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.
Measured: within the first 24 postoperative hours
Secondary outcomes (10)
cumulative morphine consumption
morphine consumption will be registered at 0, 2, 4, 8, 12, 24, 48, 72 hours and 7 days after the surgery and will be calculated as the sum of the values
Measured: at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery
long-term pain control
evaluated by VAS at 48, 72 hours and 7 days after the surgery
Measured: at 48, 72 and 7 days after the surgery
dermatomal distribution of sensory loss
evaluated at 10, 20, 30 and 40 minutes after the intervention with pinprick test using Von Frey filaments
Measured: 10, 20, 30 and 40 minutes after the intervention
nausea score
Measured: at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
pruritus score
Measured: at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
ambulation time
time to patient's first walking after the surgery
Measured: after the surgery
time of recovery of bowel movement
defined as the time to first flatus
Measured: after the 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 3 days and 5 days after the sugery
postoperative length of hospital stay
time to patient's discharge
Measured: after the surgery
patient satisfaction with anesthesia
evaluated with the Chinese version of Bauer questionnaire at 48 hours after the surgery
Measured: at 48 hours 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 posted29 Jan 2018
- Study start4 Jan 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: we use this data as a pilot study
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 Nerve Block, Nephrectomy, AnalgesiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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
- Investigators
- Yuguang Huang, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414281
- Sponsor's protocol ID
- cuixulei5
- Status last verified
- Mar 2020
- First submitted
- 9 Jan 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Q, Cui X, Fei Y, Xu Z, Huang Y. Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial. Trials. 2019 May 20;20(1):276. doi: 10.1186/s13063-019-3359-7.
PubMed 31109368
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmuscular Quadratus Lumborum Block Versus Thoracic Paravertebral Block for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
- ClinicalTrials.gov ID
- NCT03414281
- Acronym / sponsor ID
- cuixulei5
- Conditions
- Nerve Block, Nephrectomy, Analgesia
- Keywords
- quadratus lumborum block, thoracic paravertebral block, nephrectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: we use this data as a pilot study
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cui XuleiUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 29 Jan 2018 (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 trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (TPVB).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TMQLB group 1 | Experimental | Procedure: TMQLB group 10.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. |
| TMQLB group 2 | Experimental | Procedure: TMQLB group 20.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach. |
| TPVB group | Active comparator | Procedure: TPVB0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 17~80 years of age;
- American Society of Anesthesiologists physical status I-III;
- undergoing laparoscopic nephrectomy.
Key exclusion criteria (5 listed)
- have a known allergy to the anesthetics being used;
- infection at injection site
- coagulopathy or history of anticoagulants use
- chronic analgesics consumption or history of substance abuse
- inability to properly describe postoperative pain or recovery to investigators (e.g., 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 |
|---|---|---|
| TMQLB group 1The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine. | Procedure or surgery | TMQLB group 1 |
| TMQLB group 2The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine. | Procedure or surgery | TMQLB group 2 |
| TPVBThe patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10. Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine. | Procedure or surgery | TPVB group |
Primary outcome
mean VAS of the first postoperative 24 hours
Time frame: within the first 24 postoperative hours
VAS 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. The VAS will be registered at 0, 2, 4, 8, 12, 24 hours after the surgery, and the primary outcome will be calculated as the mean VAS scores measured at these time point.
10 secondary outcomes
cumulative morphine consumption
Time frame: at 0, 2,4, 8, 12, 24 ,48, 72hours and 7 day after the surgery
long-term pain control
Time frame: at 48, 72 and 7 days after the surgery
dermatomal distribution of sensory loss
Time frame: 10, 20, 30 and 40 minutes after the intervention
nausea score
Time frame: at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
pruritus score
Time frame: at 0, 2, 4, 8, 12, 24 and 48 hours after the surgery;
ambulation time
Time frame: after the surgery
time of recovery of bowel movement
Time frame: after the surgery
quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
Time frame: at 3 days and 5 days after the sugery
postoperative length of hospital stay
Time frame: after the surgery
patient satisfaction with anesthesia
Time frame: at 48 hours after the surgery
Results and safety
The study was stopped early (reason given: we use this data as a pilot study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Derived from this study: PubMed 31109368Yuan Q, Cui X, Fei Y, Xu Z, Huang Y. Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial. Trials. 2019 May 20;20(1):276. doi: 10.1186/s13063-019-3359-7.
- 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.
Yuguang Huang study chair
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 TMQLB group 1, TMQLB group 2 and TPVB in people with Nerve Block, Nephrectomy, Analgesia, 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 3 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 20 Mar 2020. 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 was stopped early (reason given: we use this data as a pilot study). 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?
mean VAS of the first postoperative 24 hours (time frame: within the first 24 postoperative 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 NCT03414281, 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 20 Mar 2020.