CholecystitisTQLNCT02225418
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy
A study testing Ropivacaine and saline in people with Cholecystitis and Pain, run by Jens Borglum Neimann at 1 site in Denmark.
Trial summary
The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder. The trial will compare active TQL block versus placebo TQL block after said operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Pain
- What is being tested?
- Ropivacaine and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for elective laparoscopic cholecystectomy
- received oral and written information about the trial
- American Society of Anaethesiologists (ASA) classification 1-3
- NRS score > 3 upon arrival at the PACU area
Who cannot join
- Cannot cooperate
- Does not speak or understand Danish
- Allergy towards drugs used in the trial
- Large daily consumption of opioids
- Known alcohol og medicin abuse
- Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.
The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.
The trial will compare active TQL block versus placebo TQL block after said operation.
The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.
- Conditions
- Cholecystitis, Pain
- Being tested
- Ropivacaine, saline
- Keywords
- Laparoscopic, Cholecystectomy, Postoperative, Pain, Quadratus lumborum, Ultrasound
- Medical subject headings
- Cholecystitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called naropin
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo TQL block | Sham comparator | 30 ml single shot TQL block with saline 0,9% Receives: Drug: saline |
| Active TQL block | Active comparator | 30 ml single shot TQL block with ropivacaine 0,75% Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score in sitting position
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
Measured: 1 hour
Secondary outcomes (5)
Pain score at rest
NRS score after administration of TQL block at said time points
Measured: 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
Pain score at sitting position
NRS score after administration of TQL block at said time points
Measured: 15 min 30 min 2 hour 3 hour 4 hour 5 hour
Total opioid consumption in PACU area
During stay in PACU area
Measured: On average 3 hours
Opioid side effects (nausea, vomiting)
During stay in PACU area
Measured: On average 3 hours
Length of stay in PACU area
Total time in PACU area
Measured: On average 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
Why it stopped: Change of jobs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Borglum Neimann
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor-investigator, Jens Borglum Neimann, Bispebjerg Hospital
- Investigators
- Jens Børglum, MD, PhD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225418
- Sponsor's protocol ID
- BBH-TQL-LC
- Other IDs
- 2013-001364-30
- Acronym
- TQL
- Status last verified
- Jul 2015
- First submitted
- 28 Jan 2014
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02225418
- Acronym / sponsor ID
- TQL / BBH-TQL-LC
- Conditions
- Cholecystitis, Pain
- Keywords
- Laparoscopic, Cholecystectomy, Postoperative, Pain, Quadratus lumborum, Ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of jobs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jens Borglum NeimannUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- First posted
- 26 Aug 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.
The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.
The trial will compare active TQL block versus placebo TQL block after said operation.
The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo TQL block | Sham comparator | Drug: saline30 ml single shot TQL block with saline 0,9% |
| Active TQL block | Active comparator | Drug: Ropivacaine30 ml single shot TQL block with ropivacaine 0,75% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for elective laparoscopic cholecystectomy
- received oral and written information about the trial
- American Society of Anaethesiologists (ASA) classification 1-3
- NRS score > 3 upon arrival at the PACU area
Key exclusion criteria (7 listed)
- Cannot cooperate
- Does not speak or understand Danish
- Allergy towards drugs used in the trial
- Large daily consumption of opioids
- Known alcohol og medicin abuse
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 |
|---|---|---|
| RopivacaineAlso: naropin | Drug | Active TQL block |
| saline | Drug | Placebo TQL block |
Primary outcome
Pain score in sitting position
Time frame: 1 hour
Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
5 secondary outcomes
Pain score at rest
Time frame: 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
Pain score at sitting position
Time frame: 15 min 30 min 2 hour 3 hour 4 hour 5 hour
Total opioid consumption in PACU area
Time frame: On average 3 hours
Opioid side effects (nausea, vomiting)
Time frame: On average 3 hours
Length of stay in PACU area
Time frame: On average 3 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 22 Jul 2015.
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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.
Jens Børglum, MD, PhD principal investigator
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and saline in people with Cholecystitis and Pain, run by Jens Borglum Neimann 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 7 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 22 Jul 2015. 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.
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?
Pain score in sitting position (time frame: 1 hour). 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 22 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.