Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE December 4, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
opiate consumption [ Time Frame: 24 hours ]
cumulative opiate consumption postoperatively
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • opiate consumption [ Time Frame: 72 hours ]
    cumulative opiate consumption postoperatively
  • postoperative nausea [ Time Frame: 72 hours ]
    numerical rating scale
  • pain score [ Time Frame: 7 days ]
    numerical rating scale
  • mobilization [ Time Frame: 72 hours ]
    time to standing up and mobilizing after surgery
  • quality of life [ Time Frame: 12 months ]
    SF36 query
  • persistent pain [ Time Frame: 12 months ]
    paindetect McGill
  • functional query [ Time Frame: 12 months ]
    assessment how pain in operation region limits daily functions
  • postoperative vomiting [ Time Frame: 72 hours ]
    amount of vomites
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery
Official Title  ICMJE Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Postoperative Pain
  • Chronic Pain Post-Proceduraal
  • Nausea and Vomiting, Postoperative
Intervention  ICMJE
  • Drug: Dexamethasone sodium phosphate
    Dexamethasone injection
    Other Name: Oradexon
  • Drug: Ropivacaine Hydrocloride
    Ropivacaine injection
  • Drug: Sodium Chloride 9mg/mL
    Sodium Chloride injection
    Other Name: Saline
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Dexamethasone sodium phosphate
    • Drug: Ropivacaine Hydrocloride
  • 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
    Interventions:
    • Drug: Ropivacaine Hydrocloride
    • Drug: Sodium Chloride 9mg/mL
  • Placebo Comparator: Placebo
    Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml
    Intervention: Drug: Sodium Chloride 9mg/mL
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eija Junttila, PhD +358331166001 eija.junttila@pshp.fi
Contact: Andrus Korgvee, MD +358331169617 andrus.korgvee@pshp.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339284
Other Study ID Numbers  ICMJE R17103M
2017-002254-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maija Kalliomaki, PhD Tampere University Hospital, Department of Anesthesia
PRS Account Tampere University Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP