Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 406 for:    sodium phosphate

QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03339284
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Chronic Pain Post-Proceduraal Nausea and Vomiting, Postoperative Drug: Dexamethasone sodium phosphate Drug: Ropivacaine Hydrocloride Drug: Sodium Chloride 9mg/mL Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients are randomized and allocated in blocks of nine to either placebo or QLB with dexamethasone or QLB without dexamethasone group
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: QLB with dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml
Drug: Dexamethasone sodium phosphate
Dexamethasone injection
Other Name: Oradexon

Drug: Ropivacaine Hydrocloride
Ropivacaine injection

Active Comparator: QLB without dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
Drug: Ropivacaine Hydrocloride
Ropivacaine injection

Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Name: Saline

Placebo Comparator: Placebo
Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Name: Saline




Primary Outcome Measures :
  1. opiate consumption [ Time Frame: 24 hours ]
    cumulative opiate consumption postoperatively


Secondary Outcome Measures :
  1. opiate consumption [ Time Frame: 72 hours ]
    cumulative opiate consumption postoperatively

  2. postoperative nausea [ Time Frame: 72 hours ]
    numerical rating scale

  3. pain score [ Time Frame: 7 days ]
    numerical rating scale

  4. mobilization [ Time Frame: 72 hours ]
    time to standing up and mobilizing after surgery

  5. quality of life [ Time Frame: 12 months ]
    SF36 query

  6. persistent pain [ Time Frame: 12 months ]
    paindetect McGill

  7. functional query [ Time Frame: 12 months ]
    assessment how pain in operation region limits daily functions

  8. postoperative vomiting [ Time Frame: 72 hours ]
    amount of vomites



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with renal cancer coming to the laparoscopic radical nephrectomy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339284


Contacts
Layout table for location contacts
Contact: Eija Junttila, PhD +358331166001 eija.junttila@pshp.fi
Contact: Andrus Korgvee, MD +358331169617 andrus.korgvee@pshp.fi

Locations
Layout table for location information
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Andrus Korgvee, MD    0358331169617    andrus.korgvee@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Maija Kalliomaki, PhD Tampere University Hospital, Department of Anesthesia

Publications:
Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki.
Ljungberg B1, Bensalah K2, Canfield S3, Dabestani S4, Hofmann F5, Hora M6, Kuczyk MA7, Lam T8, Marconi L9, Merseburger AS7, Mulders P10, Powles T11, Staehler M12, Volpe A13, Bex A14. EAU guidelines on renal cell carcinoma: 2014 update.Eur Urol. 2015 May;67(5):91324.doi:10.1016/j.eururo.2015.01.005. Epub 2015 Jan 21

Layout table for additonal information
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03339284     History of Changes
Other Study ID Numbers: R17103M
2017-002254-37 ( EudraCT Number )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dexamethasone 21-phosphate
Pain, Postoperative
Chronic Pain
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea
Dexamethasone
Dexamethasone acetate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action