QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

NCT03339284 | Unknown Phase 4

• 2 other identifiers: R17103M2017-002254-37
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• opiate consumption

  cumulative opiate consumption postoperatively

  24 hours

Secondary Outcomes (8)

• opiate consumption

  72 hours

• postoperative nausea

  72 hours

• pain score

  7 days

• mobilization

  72 hours

• quality of life

  12 months

Study Arms (3)

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

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

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

Drug: Sodium Chloride 9mg/mL

Interventions

Dexamethasone sodium phosphate DRUG

Dexamethasone injection

Also known as: Oradexon

QLB with dexamethasone

Ropivacaine Hydrocloride DRUG

Ropivacaine injection

QLB with dexamethasone; QLB without dexamethasone

Sodium Chloride 9mg/mL DRUG

Sodium Chloride injection

Also known as: Saline

Placebo; QLB without dexamethasone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with renal cancer coming to the laparoscopic radical nephrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

RECRUITING

Related Publications (16)

• Finnish Cancer Registry. Cancer in Finland 2007-2011. Cancer Society of Finland Publication, Helsinki.

  BACKGROUND

• 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.

  PMID: 25616710 BACKGROUND

• 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.

  PMID: 11696714 BACKGROUND

• 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.

  PMID: 23150820 BACKGROUND

• Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

  PMID: 26509324 BACKGROUND

• 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.

  PMID: 26735154 BACKGROUND

• 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.

  PMID: 27755488 BACKGROUND

• 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.

  PMID: 25642956 BACKGROUND

• 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.

  PMID: 26355598 BACKGROUND

• 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.

  PMID: 25774458 BACKGROUND

• 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.

  PMID: 25123271 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 26719073 BACKGROUND

• 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.

  PMID: 26827847 BACKGROUND

• 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.

  PMID: 22323381 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

dexamethasone 21-phosphate; Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maija Kalliomaki, PhD

  Tampere University Hospital, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eija Junttila, PhD

CONTACT

+358331166001; eija.junttila@pshp.fi

Andrus Korgvee, MD

CONTACT

+358331169617; andrus.korgvee@pshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are randomized and allocated in blocks of nine to either placebo or QLB with dexamethasone or QLB without dexamethasone group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 13, 2017
• Study Start: December 4, 2017
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)