QLB and Laparoscopic Nephrectomy, Postoperative Pain and Recovery

Postoperative Pain Clinical Trial

Official title:

Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339284
• Other study ID #: R17103M
• Secondary ID: 2017-002254-37
• Status: Recruiting
• Phase: Phase 4
• Start date: December 4, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2021
• Source: Tampere University Hospital
• Contact: Eija Junttila, PhD
• Phone: +358331166001
• Email: eija.junttila[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexamethasone sodium phosphate
Dexamethasone injection
• Ropivacaine Hydrocloride
Ropivacaine injection
• Sodium Chloride 9mg/mL
Sodium Chloride injection

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (16)

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. Review. — View 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. — View 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. Erratum in: Reg Anesth Pain Med. 2018;43:111. — View 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. — View 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. — View 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. — View Citation

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

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. Review. — View 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. — View 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. Review. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View 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. — View Citation

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

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. — View 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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opiate consumption	cumulative opiate consumption postoperatively	24 hours
Secondary	opiate consumption	cumulative opiate consumption postoperatively	72 hours
Secondary	postoperative nausea	numerical rating scale	72 hours
Secondary	pain score	numerical rating scale	7 days
Secondary	mobilization	time to standing up and mobilizing after surgery	72 hours
Secondary	quality of life	SF36 query	12 months
Secondary	persistent pain	paindetect McGill	12 months
Secondary	functional query	assessment how pain in operation region limits daily functions	12 months
Secondary	postoperative vomiting	amount of vomites	72 hours