Postoperative PainPhase 4NCT03571490
Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy
A Phase 4 study testing Ropivacaine and Saline in people with Postoperative Pain and Ultrasound Guided Transmuscular Quadratus Lumborum Block, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Ultrasound Guided Transmuscular Quadratus Lumborum Block
- What is being tested?
- Ropivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jun 2018to 24 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years
- Kidney cancer
- Have received thorough information, orally and in written
- Signed the "Informed Consent" form on participation in the trial
Who cannot join
- Inability to cooperate
- Inability to speak and understand Danish both orally and written
- Allergy to local anaesthetics or opioids
- Daily intake of opioids
- Local infection at the site of injection or systemic infection
- Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
- Known abuse of alcohol or medicine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.
- Being tested
- Ropivacaine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Single shot of ropivacaine 0.325%
SalineDrug
Single shot of saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| TQL Ropivacaine(active) | Active comparator | Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine Receives: Drug: Ropivacaine |
| TQL saline (placebo) | Placebo comparator | Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9% Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).
Measured: 12 hours postoperatively
Secondary outcomes (13)
opioid consumption
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Measured: 6 hours postoperatively
opioid consumption
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Measured: 18 hours postoperatively
opioid consumption
Opioid consumption postoperatively (data from PCA pump and patient medical record).
Measured: 24 hours postoperatively
NRS score
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity
Measured: 12 hours postoperatively
NRS score at rest and activity
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Measured: 6 hours postoperatively
NRS score at rest and activity
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Measured: 18 hours postoperatively
NRS score at rest and activity
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Measured: 24 hours postoperatively
Opioid-related side effects
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Measured: 6 hours postoperatively
Opioid-related side effects
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Measured: 12 hours postoperatively
Opioid-related side effects
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Measured: 18 hours postoperatively
Opioid-related side effects
The degree of morphine-related side effects (PONV, itching, fatigue, etc.)
Measured: 24 hours postoperatively
Patient satisfaction with application of the block. NRS
Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain
Measured: Immediately after application of the block
Ambulation
Time from operation to ambulation
Measured: within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start26 Jun 2018
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Zealand University 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Double blind placebo Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571490
- Sponsor's protocol ID
- V2.02.05.2017
- Other IDs
- 2017-002130-23, 2017
- Status last verified
- Mar 2020
- First submitted
- 27 Oct 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26.
PubMed 33106280
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03571490
- Acronym / sponsor ID
- V2.02.05.2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 27 Jun 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.
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| TQL Ropivacaine(active) | Active comparator | Drug: RopivacaineBilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine |
| TQL saline (placebo) | Placebo comparator | Drug: SalineBilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years
- Kidney cancer
- Have received thorough information, orally and in written
- Signed the "Informed Consent" form on participation in the trial
Key exclusion criteria (8 listed)
- Inability to cooperate
- Inability to speak and understand Danish both orally and written
- Allergy to local anaesthetics or opioids
- Daily intake of opioids
- Local infection at the site of injection or systemic infection
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 |
|---|---|---|
| RopivacaineSingle shot of ropivacaine 0.325% | Drug | TQL Ropivacaine(active) |
| SalineSingle shot of saline 0.9% | Drug | TQL saline (placebo) |
Primary outcome
opioid consumption
Time frame: 12 hours postoperatively
Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).
13 secondary outcomes
opioid consumption
Time frame: 6 hours postoperatively
opioid consumption
Time frame: 18 hours postoperatively
opioid consumption
Time frame: 24 hours postoperatively
NRS score
Time frame: 12 hours postoperatively
NRS score at rest and activity
Time frame: 6 hours postoperatively
NRS score at rest and activity
Time frame: 18 hours postoperatively
NRS score at rest and activity
Time frame: 24 hours postoperatively
Opioid-related side effects
Time frame: 6 hours postoperatively
Opioid-related side effects
Time frame: 12 hours postoperatively
Opioid-related side effects
Time frame: 18 hours postoperatively
Opioid-related side effects
Time frame: 24 hours postoperatively
Patient satisfaction with application of the block. NRS
Time frame: Immediately after application of the block
Ambulation
Time frame: within 24 hours postoperatively
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 19 Mar 2020.
- Derived from this study: PubMed 33106280Dam M, Hansen C, Poulsen TD, Azawi NH, Laier GH, Wolmarans M, Chan V, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block reduces opioid consumption and prolongs time to first opioid demand after laparoscopic nephrectomy. Reg Anesth Pain Med. 2021 Jan;46(1):18-24. doi: 10.1136/rapm-2020-101745. Epub 2020 Oct 26.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Ropivacaine and Saline in people with Postoperative Pain and Ultrasound Guided Transmuscular Quadratus Lumborum Block, run by Zealand University Hospital at 1 site in Denmark.
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 8 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 19 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 Denmark. 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.
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 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?
opioid consumption (time frame: 12 hours postoperatively). 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 NCT03571490, 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 19 Mar 2020.