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QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Primary Purpose

Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dexamethasone sodium phosphate
Ropivacaine Hydrocloride
Sodium Chloride 9mg/mL
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

QLB with dexamethasone

QLB without dexamethasone

Placebo

Arm Description

Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml

Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml

Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml

Outcomes

Primary Outcome Measures

opiate consumption
cumulative opiate consumption postoperatively

Secondary Outcome Measures

opiate consumption
cumulative opiate consumption postoperatively
postoperative nausea
numerical rating scale
pain score
numerical rating scale
mobilization
time to standing up and mobilizing after surgery
quality of life
SF36 query
persistent pain
paindetect McGill
functional query
assessment how pain in operation region limits daily functions
postoperative vomiting
amount of vomites

Full Information

First Posted
November 3, 2017
Last Updated
December 22, 2021
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03339284
Brief Title
QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery
Official Title
Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Chronic Pain Post-Proceduraal, Nausea and Vomiting, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients are randomized and allocated in blocks of nine to either placebo or QLB with dexamethasone or QLB without dexamethasone group
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLB with dexamethasone
Arm Type
Active Comparator
Arm Description
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml
Arm Title
QLB without dexamethasone
Arm Type
Active Comparator
Arm Description
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml
Intervention Type
Drug
Intervention Name(s)
Dexamethasone sodium phosphate
Other Intervention Name(s)
Oradexon
Intervention Description
Dexamethasone injection
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrocloride
Intervention Description
Ropivacaine injection
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 9mg/mL
Other Intervention Name(s)
Saline
Intervention Description
Sodium Chloride injection
Primary Outcome Measure Information:
Title
opiate consumption
Description
cumulative opiate consumption postoperatively
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
opiate consumption
Description
cumulative opiate consumption postoperatively
Time Frame
72 hours
Title
postoperative nausea
Description
numerical rating scale
Time Frame
72 hours
Title
pain score
Description
numerical rating scale
Time Frame
7 days
Title
mobilization
Description
time to standing up and mobilizing after surgery
Time Frame
72 hours
Title
quality of life
Description
SF36 query
Time Frame
12 months
Title
persistent pain
Description
paindetect McGill
Time Frame
12 months
Title
functional query
Description
assessment how pain in operation region limits daily functions
Time Frame
12 months
Title
postoperative vomiting
Description
amount of vomites
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eija Junttila, PhD
Phone
+358331166001
Email
eija.junttila@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Andrus Korgvee, MD
Phone
+358331169617
Email
andrus.korgvee@pshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija Kalliomaki, PhD
Organizational Affiliation
Tampere University Hospital, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrus Korgvee, MD
Phone
0358331169617
Email
andrus.korgvee@pshp.fi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki.
Results Reference
background
PubMed Identifier
25616710
Citation
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.
Results Reference
background
PubMed Identifier
11696714
Citation
Chan 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.
Results Reference
background
PubMed Identifier
23150820
Citation
Mathuram 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.
Results Reference
background
PubMed Identifier
26509324
Citation
Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
Results Reference
background
PubMed Identifier
26735154
Citation
Murouchi 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.
Results Reference
background
PubMed Identifier
27755488
Citation
Blanco 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. Erratum In: Reg Anesth Pain Med. 2018;43:111.
Results Reference
background
PubMed Identifier
25642956
Citation
Chakraborty 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.
Results Reference
background
PubMed Identifier
26355598
Citation
Kirksey 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.
Results Reference
background
PubMed Identifier
25774458
Citation
Huynh 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.
Results Reference
background
PubMed Identifier
25123271
Citation
Albrecht 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.
Results Reference
background
PubMed Identifier
16698416
Citation
Kehlet 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.
Results Reference
background
PubMed Identifier
26719073
Citation
Gordon 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.
Results Reference
background
PubMed Identifier
26827847
Citation
Chou 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. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
Results Reference
background
PubMed Identifier
22323381
Citation
Gustavsson 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.
Results Reference
background
PubMed Identifier
26225500
Citation
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
Results Reference
background

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QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

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