Local Anaesthetic and Steroid in the Ureter

NCT03296189 | Unknown

• 1 other identifier: AMNCH-GU-2017-2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Précis: Randomised control trial to evaluate safety and efficacy of intraluminal injection of high pH-high concentration of a long-acting local anesthetic and long-acting glucocorticoid in the ureter after ureteroscopy. Objectives: To evaluate a novel method to ameliorate post-ureteroscopy pain in all patients (with and without stents) Endpoints: Primary endpoint: mean visual analog pain scale (VAS) post-operatively starting at 1 hour, 4 hours, 8 hours, 24 hours and 7 days post-procedure (minimum of 3 VAS scores). VAS pain, ureteral stent symptoms and analgesic requirement will be assessed at different points during this time period. Secondary endpoint: Postoperative Nausea/Vomiting (PONV), safety of intraluminal injection of high concentration alkalinized local anaesthetic solution by comparing adverse events between placebo and treatment arms. In addition, rehospitalisation rates and postoperative length of stay will be compared between the three groups. Population: 150 adult patients undergoing ureteroscopy for ureteric stone disease stratified into negative ureteroscopy and those treated for a stone with or without stent insertion postoperatively Number of Sites: Tallaght Hospital Study Duration: 8 months

Conditions

Pain, Postoperative; Ureter Stone

Keywords

ureteroscopy; ureteric stent; intraluminal; local anaesthetic/anesthetic; steroid/glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Pain

  Visual Analog Pain Scale (VAS) at least 3 different time points post-ureteroscopy

  at up to 7 days post op

Secondary Outcomes (4)

• Postoperative Nausea and Vomiting (PONV)

  at up to 7 days post op

• Length of stay post-op

  at up to 7 days post op

• rehospitalisation rate

  at up to 7 days post op

• Need for analgesia

  at up to 7 days post op

Study Arms (3)

Local anaesthetic

ACTIVE COMPARATOR

Post-ureteroscopy intraluminal injection of alkalinised high concentration levo-bupivicaine in the renal pelvis

Drug: Levobupivacaine

Local anaesthetic + steroid

ACTIVE COMPARATOR

Post-ureteroscopy intraluminal injection of 10 mls alkalinised high concentration levo-bupivicaine with l dexamethasone in the renal pelvis

Drug: Dexamethasone Sodium Phosphate

Placebo

PLACEBO COMPARATOR

Post-ureteroscopy intraluminal injection of 10 mls normal saline (placebo) in the renal pelvis

Drug: Placebos

Interventions

Levobupivacaine DRUG

intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls

Local anaesthetic

Dexamethasone Sodium Phosphate DRUG

intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls levobupivicaine and 2mls dexamethasone

Local anaesthetic + steroid

Placebos DRUG

10 mls normal saline

Placebo

Eligibility Criteria

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

You may qualify if:

• Any patient undergoing ureteroscopy for ureteric stone disease
• Able to undergo a general anaesthetic
• At least 18 years old
• Willing and able to complete patient symptom questionnaires

You may not qualify if:

• Solitary Kidney
• Renal failure
• Anatomic bladder or ureteral abnormality
• Uncorrected coagulopathy
• Previous cystectomy or urinary diversion
• Neurogenic bladder
• Interstitial cystitis
• Transplanted kidney
• Pregnancy
• Requires an indwelling catheter
• Recurrent urinary tract infections
• Pelvic kidney
• Requires bilateral treatment/stents
• Previous bladder or ureteral reconstructive surgery
• Ureteral perforation during procedure

Sponsors & Collaborators

• The Adelaide and Meath Hospital, incorporating The National Children's Hospital: lead

Study Sites (1)

Adelaide and Meath incorporating National Children's hopsital

Dublin, 24, Ireland

Location

Related Publications (10)

• El Harrech Y, Abakka N, El Anzaoui J, Ghoundale O, Touiti D. Ureteral stenting after uncomplicated ureteroscopy for distal ureteral stones: a randomized, controlled trial. Minim Invasive Surg. 2014;2014:892890. doi: 10.1155/2014/892890. Epub 2014 Nov 9.

  PMID: 25431663 BACKGROUND

• Burdyga ThV, Magura IS. The effects of local anaesthetics on the electrical and mechanical activity of the guinea-pig ureter. Br J Pharmacol. 1986 Jul;88(3):523-30. doi: 10.1111/j.1476-5381.1986.tb10232.x.

  PMID: 3742148 BACKGROUND

• Ross JA EP, Kirkland IS. Ibid. 1972:125.

  BACKGROUND

• Andersson KE, Ulmsten U. Effects of spinal anaesthesia, lidocaine, and morphine, on the motility of the human ureter in vivo. Scand J Urol Nephrol. 1975;9(3):236-42. doi: 10.3109/00365597509134219.

  PMID: 1209180 BACKGROUND

• Boyarsky ASaS. The Pharmacology of the Urinary Tract. In: Caine M, editor.1984.

  BACKGROUND

• Sur RL, Haleblian GE, Cantor DA, Springhart WP, Albala DM, Preminger GM. Efficacy of intravesical ropivacaine injection on urinary symptoms following ureteral stenting: a randomized, controlled study. J Endourol. 2008 Mar;22(3):473-8. doi: 10.1089/end.2007.9847.

  PMID: 18290733 BACKGROUND

• Nickel JC, Moldwin R, Lee S, Davis EL, Henry RA, Wyllie MG. Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. BJU Int. 2009 Apr;103(7):910-8. doi: 10.1111/j.1464-410X.2008.08162.x. Epub 2008 Nov 13.

  PMID: 19021619 BACKGROUND

• The American Heritage® Stedman's Medical Dictionary. http://www.dictionary.com/browse/life-expectancy. Accessed 13/12/16. 2002.

  BACKGROUND

• Angelo-Khattar M, Thulesius O, Cherian T. The effect of glucocorticosteroids on in vitro motility of the ureter of the sheep. Br J Pharmacol. 1989 Mar;96(3):527-30. doi: 10.1111/j.1476-5381.1989.tb11849.x.

  PMID: 2720291 BACKGROUND

• Manchikanti L, Manchikanti KN, Manchukonda R, Cash KA, Damron KS, Pampati V, McManus CD. Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914. Pain Physician. 2007 May;10(3):425-40.

  PMID: 17525777 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Ureterolithiasis

Interventions

Levobupivacaine; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Nikita Bhatt

CONTACT

00353860609430; nikitarb89@gmail.com

Rustom Manecksha

CONTACT

rustom.manecksha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 10 mls of solution will be handed to operating surgeon by the scrub nurse. The nurse will be the only person aware of the solution content and it will be documented discreetly. The operating surgeon, the investigator and the patients will not be aware of the solution used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Three arm double-blinded prospective randomised controlled trial

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 28, 2017
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

IE (1)