Postoperative PainPhase 4NCT03339284
QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery
A Phase 4 study testing Dexamethasone sodium phosphate, Ropivacaine Hydrocloride and Sodium Chloride 9mg/mL 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 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic. 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?
- Dexamethasone sodium phosphate, Ropivacaine Hydrocloride and Sodium Chloride 9mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- 4 Dec 2017to 30 Jun 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with renal cancer coming to the laparoscopic radical nephrectomy
Who cannot join
- age under 18y or over 85y
- diabetes type 1 with complications
- no co-operation or inadequate finnish language skills
- persistent pain for other reason
- severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated for other reason
- any type of steroid in regular use
- oxycodone contraindicated
- medications changing notably paracetamol (acetaminophen) and/or ropivacaine metabolism in regular use
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere
Andrus Korgvee, MD, 0358331169617, andrus.korgvee@pshp.fi
About this study
Official title: Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic.
Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.
Read more
Recently quadratus lumborum block (QLB) 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. A single shot QLB has reported to last up to 48 hours.
Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known.
90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.
- Being tested
- Dexamethasone sodium phosphate, Ropivacaine Hydrocloride, Sodium Chloride 9mg/mL
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone sodium phosphateDrug
Also called Oradexon
Dexamethasone injection
Ropivacaine HydroclorideDrug
Ropivacaine injection
Sodium Chloride 9mg/mLDrug
Also called Saline
Sodium Chloride injection
| Study group | Role | What they receive |
|---|---|---|
| QLB with dexamethasone | Active comparator | Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml Receives: Drug: Dexamethasone sodium phosphate; Drug: Ropivacaine Hydrocloride |
| QLB without dexamethasone | Active comparator | Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml Receives: Drug: Ropivacaine Hydrocloride; Drug: Sodium Chloride 9mg/mL |
| Placebo | Placebo comparator | Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml Receives: Drug: Sodium Chloride 9mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
opiate consumption
cumulative opiate consumption postoperatively
Measured: 24 hours
Secondary outcomes (8)
opiate consumption
cumulative opiate consumption postoperatively
Measured: 72 hours
postoperative nausea
numerical rating scale
Measured: 72 hours
pain score
numerical rating scale
Measured: 7 days
mobilization
time to standing up and mobilizing after surgery
Measured: 72 hours
quality of life
SF36 query
Measured: 12 months
persistent pain
paindetect McGill
Measured: 12 months
functional query
assessment how pain in operation region limits daily functions
Measured: 12 months
postoperative vomiting
amount of vomites
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start4 Dec 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 Tampere 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maija Kalliomaki, PhD, Principal investigator, Tampere University Hospital, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339284
- Sponsor's protocol ID
- R17103M
- Other IDs
- 2017-002254-37, 2017
- Status last verified
- Dec 2021
- First submitted
- 3 Nov 2017
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki.
Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
PubMed 25616710Chan DY, Cadeddu JA, Jarrett TW, Marshall FF, Kavoussi LR. Laparoscopic radical nephrectomy: cancer control for renal cell carcinoma. J Urol. 2001 Dec;166(6):2095-9; discussion 2099-100. doi: 10.1016/s0022-5347(05)65513-9.
PubMed 11696714Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
PubMed 23150820Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PubMed 26509324Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
PubMed 26735154Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
PubMed 25642956Kirksey MA, Haskins SC, Cheng J, Liu SS. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015 Sep 10;10(9):e0137312. doi: 10.1371/journal.pone.0137312. eCollection 2015.
PubMed 26355598Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
PubMed 25774458Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
PubMed 25123271Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Gordon DB, de Leon-Casasola OA, Wu CL, Sluka KA, Brennan TJ, Chou R. Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline. J Pain. 2016 Feb;17(2):158-66. doi: 10.1016/j.jpain.2015.10.023. Epub 2015 Dec 21.
PubMed 26719073Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Gustavsson A, Bjorkman J, Ljungcrantz C, Rhodin A, Rivano-Fischer M, Sjolund KF, Mannheimer C. Socio-economic burden of patients with a diagnosis related to chronic pain--register data of 840,000 Swedish patients. Eur J Pain. 2012 Feb;16(2):289-99. doi: 10.1016/j.ejpain.2011.07.006.
PubMed 22323381
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT03339284
- Acronym / sponsor ID
- R17103M
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 13 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 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic.
Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.
Recently quadratus lumborum block (QLB) 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. A single shot QLB has reported to last up to 48 hours.
Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known.
90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QLB with dexamethasone | Active comparator | Drug: Dexamethasone sodium phosphate, Drug: Ropivacaine HydroclorideSingle sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml |
| QLB without dexamethasone | Active comparator | Drug: Ropivacaine Hydrocloride, Drug: Sodium Chloride 9mg/mLSingle sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml |
| Placebo | Placebo comparator | Drug: Sodium Chloride 9mg/mLSingle sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml |
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 renal cancer coming to the laparoscopic radical nephrectomy
Key exclusion criteria (8 listed)
- age under 18y or over 85y
- diabetes type 1 with complications
- no co-operation or inadequate finnish language skills
- persistent pain for other reason
- severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated 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 |
|---|---|---|
| Dexamethasone sodium phosphateAlso: OradexonDexamethasone injection | Drug | QLB with dexamethasone |
| Ropivacaine HydroclorideRopivacaine injection | Drug | QLB with dexamethasone, QLB without dexamethasone |
| Sodium Chloride 9mg/mLAlso: SalineSodium Chloride injection | Drug | Placebo, QLB without dexamethasone |
Primary outcome
opiate consumption
Time frame: 24 hours
cumulative opiate consumption postoperatively
8 secondary outcomes
opiate consumption
Time frame: 72 hours
postoperative nausea
Time frame: 72 hours
pain score
Time frame: 7 days
mobilization
Time frame: 72 hours
quality of life
Time frame: 12 months
persistent pain
Time frame: 12 months
functional query
Time frame: 12 months
postoperative vomiting
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- BackgroundFinnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki.
- Background: PubMed 25616710Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, Mulders P, Powles T, Staehler M, Volpe A, Bex A. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015 May;67(5):913-24. doi: 10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21.
- Background: PubMed 11696714Chan DY, Cadeddu JA, Jarrett TW, Marshall FF, Kavoussi LR. Laparoscopic radical nephrectomy: cancer control for renal cell carcinoma. J Urol. 2001 Dec;166(6):2095-9; discussion 2099-100. doi: 10.1016/s0022-5347(05)65513-9.
- Background: PubMed 23150820Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
- Background: PubMed 26509324Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
- Background: PubMed 26735154Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
- Background: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Background: PubMed 25642956Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.
- Background: PubMed 26355598Kirksey MA, Haskins SC, Cheng J, Liu SS. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015 Sep 10;10(9):e0137312. doi: 10.1371/journal.pone.0137312. eCollection 2015.
- Background: PubMed 25774458Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248.
- Background: PubMed 25123271Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- 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 Kalliomaki, PhD principal investigator
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 Phase 4 study testing Dexamethasone sodium phosphate, Ropivacaine Hydrocloride and Sodium Chloride 9mg/mL 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 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: status not confirmed, as of the sponsor's last update on 23 Dec 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eija Junttila, PhD (+358331166001, eija.junttila@pshp.fi), or a site near the patient. 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 NCT03339284, which also lists 16 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 23 Dec 2021.