Postoperative PainBladderQLBNCT03328988
QLB and Radical Cystectomy, Postoperative Pain
A study testing QLB in people with Postoperative Pain and Chronic Pain Post-Proceduraal, run by Tampere University Hospital at 1 site in Finland.
Trial summary
There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative
- What is being tested?
- QLB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFinland
- Study dates
- 27 Apr 2017to 31 Aug 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with bladder cancer coming to the open radical cystectomy.
Who cannot join
- age under 18y or over 85y,
- diabetes type 1 with complications,
- no co-operation or inadequate finnish language,
- persistent pain for other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Two Different Analgesic Block Methods for Postoperative Pain and Recovery After Surgery -Quadratus Lumborum Block (QLB): the Effect on Peri- and Postoperative Pain and Recovery After Radical Cystectomy
There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.
Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.
44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.
Read the detailed description
44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.
The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.
- Being tested
- QLB
- Keywords
- bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLBProcedure or surgery
Also called quadratus lumborum block
bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Experimental | Single shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group. Receives: Procedure: QLB |
| Epidural | No intervention | Epidural catheter (placed before anesthesia induction), ropivacaine 75 mg in 50 mL isotonic saline (1,5 mg/mL), induction bolus after surgery 1 mL/10 kg ideal weight and there on continuous infusion 2-8 mL/h according to analgesic need. 22 patients will be allocated in this group. This is the current standard for postoperative pain relief in cystectomy patients in our hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
opiate consumption
intravenous patient controlled analgesia
Measured: 24 hours
Secondary outcomes (6)
pain score
numerical rating scale
Measured: 7 days
postoperative nausea and vomiting
numerical rating scale and amount of vomites
Measured: 72 hours
mobilisation
standing up and mobilizing
Measured: 72 hours after surgery
quality of life
SF 36
Measured: 12 months
persistent pain
paindetect McGill
Measured: 12 months
functional query
assessment how pain in operation region limits daily functions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start27 Apr 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Model description
- Prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija-Liisa Kalliomaki, PhD, Study director, Tampere University Hospital, Department of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328988
- Sponsor's protocol ID
- R17008
- Acronym
- BladderQLB
- Status last verified
- Jan 2022
- First submitted
- 5 May 2017
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki. 2. Witjes AJ, Lebret T, Comperat EM et al. Eur Urol. 2016 Jun 30 . 3. Azhar RA, Bochner B, Catto J et al. Eur Urol. 2016; 70: 176-187. 4. Voldby AW, Brandstrup B. Journal of Intensive Care 2016; 4:27. 5. Rawal N. Eur J Anae sthesiol 2016; 33:160 - 171 6. Kehlet H, Jensen TS, Woolf CJ . Lancet. 2006 May 13;367(9522):1618- 25 7. Gordon DB, de Leon-Casasola OA, Wu CL, ET AL. The Journal of Pain 2016; 17(2): 158-166. 8. Chou R, Gordon DB, de Leon-Casasola OA, ET AL. The Journal of Pain 2016;17(2):131-157 9. Gustavsson A., Bjorkman J., Ljungcrantz C., ET AL. Eur J Pain 2012:16 ; 289 - 299 10. Breivik H, Bang U, Jalonen J, ET AL Acta Anesthesiol Scand 20 10; 54: 16- 41. 11. Davies RG, Myles PS, Graham JM Br J Anaesth. 2006 Apr;96(4):418-26. 13. 12. Murouchi T, Iwasaki S, Yamakage M. Reg Anesth Pain Med. 2016;41:146 - 150. 13. Carney J, Finnerty O, Rauf J, ET AL. Anaesthesia. 2011;66:1023 - 30. 14. Blanco R, Ansari T, Riad W, Shetty N. Reg Anest Pain Med: Nov/Dec 2016 - vol 41 - p 757- 767. 15. Kenneth F Schulz, , Douglas G Altman, David Moher, BMJ 2010;340:c332 16. http://www.consort-statement.org
Veskimae E, Korgvee A, Huhtala H, Koskinen H, Kalliomaki ML, Tammela T, Junttila E. Quadratus lumborum block is feasible alternative to epidural block for postoperative analgesia after open radical cystectomy: surgical and oncological outcomes of a randomised clinical trial. Scand J Urol. 2025 Mar 13;60:59-65. doi: 10.2340/sju.v60.43105.
PubMed 40079670Korgvee A, Veskimae E, Huhtala H, Koskinen H, Tammela T, Junttila E, Kalliomaki ML. Posterior quadratus lumborum block versus epidural analgesia for postoperative pain management after open radical cystectomy: A randomized clinical trial. Acta Anaesthesiol Scand. 2023 Mar;67(3):347-355. doi: 10.1111/aas.14188. Epub 2023 Jan 3.
PubMed 36547262
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Different Analgesic Block Methods for Postoperative Pain and Recovery After Surgery -Quadratus Lumborum Block (QLB): the Effect on Peri- and Postoperative Pain and Recovery After Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03328988
- Acronym / sponsor ID
- BladderQLB / R17008
- Keywords
- bladder cancer, radical cystectomy, epidural analgesia, quadratus lumborum block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 1 Nov 2017 (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.
There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.
Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.
44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.
Detailed description
44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.
The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Experimental | Procedure: QLBSingle shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group. |
| Epidural | No intervention | –Epidural catheter (placed before anesthesia induction), ropivacaine 75 mg in 50 mL isotonic saline (1,5 mg/mL), induction bolus after surgery 1 mL/10 kg ideal weight and there on continuous infusion 2-8 mL/h according to analgesic need. 22 patients will be allocated in this group. This is the current standard for postoperative pain relief in cystectomy patients in our hospital |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with bladder cancer coming to the open radical cystectomy.
Key exclusion criteria (4 listed)
- age under 18y or over 85y,
- diabetes type 1 with complications,
- no co-operation or inadequate finnish language,
- persistent pain for other reason.
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 |
|---|---|---|
| QLBAlso: quadratus lumborum blockbilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle | Procedure or surgery | Quadratus lumborum block |
Primary outcome
opiate consumption
Time frame: 24 hours
intravenous patient controlled analgesia
6 secondary outcomes
pain score
Time frame: 7 days
postoperative nausea and vomiting
Time frame: 72 hours
mobilisation
Time frame: 72 hours after surgery
quality of life
Time frame: 12 months
persistent pain
Time frame: 12 months
functional query
Time frame: 12 months
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 4 Jan 2022.
- Background1. Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki. 2. Witjes AJ, Lebret T, Comperat EM et al. Eur Urol. 2016 Jun 30 . 3. Azhar RA, Bochner B, Catto J et al. Eur Urol. 2016; 70: 176-187. 4. Voldby AW, Brandstrup B. Journal of Intensive Care 2016; 4:27. 5. Rawal N. Eur J Anae sthesiol 2016; 33:160 - 171 6. Kehlet H, Jensen TS, Woolf CJ . Lancet. 2006 May 13;367(9522):1618- 25 7. Gordon DB, de Leon-Casasola OA, Wu CL, ET AL. The Journal of Pain 2016; 17(2): 158-166. 8. Chou R, Gordon DB, de Leon-Casasola OA, ET AL. The Journal of Pain 2016;17(2):131-157 9. Gustavsson A., Bjorkman J., Ljungcrantz C., ET AL. Eur J Pain 2012:16 ; 289 - 299 10. Breivik H, Bang U, Jalonen J, ET AL Acta Anesthesiol Scand 20 10; 54: 16- 41. 11. Davies RG, Myles PS, Graham JM Br J Anaesth. 2006 Apr;96(4):418-26. 13. 12. Murouchi T, Iwasaki S, Yamakage M. Reg Anesth Pain Med. 2016;41:146 - 150. 13. Carney J, Finnerty O, Rauf J, ET AL. Anaesthesia. 2011;66:1023 - 30. 14. Blanco R, Ansari T, Riad W, Shetty N. Reg Anest Pain Med: Nov/Dec 2016 - vol 41 - p 757- 767. 15. Kenneth F Schulz, , Douglas G Altman, David Moher, BMJ 2010;340:c332 16. http://www.consort-statement.org
- Derived from this study: PubMed 40079670Veskimae E, Korgvee A, Huhtala H, Koskinen H, Kalliomaki ML, Tammela T, Junttila E. Quadratus lumborum block is feasible alternative to epidural block for postoperative analgesia after open radical cystectomy: surgical and oncological outcomes of a randomised clinical trial. Scand J Urol. 2025 Mar 13;60:59-65. doi: 10.2340/sju.v60.43105.
- Derived from this study: PubMed 36547262Korgvee A, Veskimae E, Huhtala H, Koskinen H, Tammela T, Junttila E, Kalliomaki ML. Posterior quadratus lumborum block versus epidural analgesia for postoperative pain management after open radical cystectomy: A randomized clinical trial. Acta Anaesthesiol Scand. 2023 Mar;67(3):347-355. doi: 10.1111/aas.14188. Epub 2023 Jan 3.
- 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.
Maija-Liisa Kalliomaki, PhD study director
Tampere University Hospital, Department of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLB in people with Postoperative Pain and Chronic Pain Post-Proceduraal, run by Tampere University Hospital at 1 site in Finland.
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 1 inclusion and 4 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 4 Jan 2022. 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 Finland. 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?
opiate consumption (time frame: 24 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 NCT03328988, which also lists 3 linked publications.
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 Jan 2022.