Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy

NCT01371422 | Terminated

• 1 other identifier: H10-02017
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized control trial (meaning the selection is random as when flipping a coin) to assess the benefit of paravertebral blockade (PVB) in Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) surgery.

Conditions

Nephrolithiasis

Keywords

Paravertebral nerve blockade; Percutaneous nephrolithotomy/nephrolithotripsy; opioids; pain

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  24 hours post-operative, one week post-operatively

Secondary Outcomes (1)

• Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications

  1, 6, and 24 hours post-operatively

Study Arms (2)

A1 (PVB)

EXPERIMENTAL

PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.

Other: Paravertebral Block (PVB)

A2 (Placebo)

PLACEBO COMPARATOR

The placebo is an inactive substance that looks identical to the test intervention but contains no active ingredients and will be administered the same as the PVB by a local skin injection, but no advancement of the needle to the paravertebral space will be made to avoid unnecessary risks.

Other: Saline

Interventions

Paravertebral Block (PVB) OTHER

The T10, T11 and T12 paravertebral spaces on the operative side will be identified with ultrasound in all patients (Sonosite MicroMax, 2-5 MHz curvilinear probe). In the PVB group, a 90mm 22g Tuohy needle will be inserted in-plane with the live ultrasound image over the transverse process at each of these levels and 5 mL of 0.5% ropivacaine will be injected at each level.

A1 (PVB)

Saline OTHER

Ultrasonography and local infiltration of saline will only be performed

A2 (Placebo)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older, able to give consent
• ASA 1, 2 or 3 patients
• Patients to undergo PCNL

You may not qualify if:

• Complex stone with anticipation of requiring \>1 access sites
• Prior diagnosis of chronic pain requiring daily opioid analgesia for \> 1 month prior to diagnosis of Nephrolithiasis
• Allergy to local anesthetic
• Local infection at site of regional anesthesia
• Back or other MSK deformity that contributes to inaccuracy of paravertebral block placement
• Severe cardiopulmonary disease
• Fibromyalgia
• Anticoagulation
• Patient with language barrier or inability to communicate

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Nephrolithiasis; Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ben Chew, MD,MSc,FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: June 10, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

CA (1)