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

NCT ID: NCT01371422

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-11-30

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.

Detailed Description

Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) is an effective treatment that offers maximal physical removal of large kidney stones. However, despite the minimally invasive nature of the procedure, postoperative pain still remains a significant concern. General anaesthetic (solution given to put the patient to sleep) for the procedure is routinely given, along with a local anaesthetic injection at the operative site (injection of anaesthetic solution to the incision area to reduce the pain after the procedure) and pain pills to reduce the pain even further after surgery. Paravertebral nerve blockade (PVB) is a technique for inserting anesthetic solution into an area near the vertebrae (bony segments that form the spinal column of humans or backbone), and is an effective method for reducing pain in the post operative period from a variety of surgeries.

The investigators expect that the PVB can decrease side effects from opioids (pain medication) and other analgesics used post-operatively. Opioid side effects include nausea, vomiting, urinary retention, constipation, and drowsiness. Other side effects associated with anaesthetic use include peptic ulcer disease and acute renal failure. The investigators also expect that PVB will result in decreased post-operative pain.

Conditions

Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A1 (PVB)

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

Group Type: EXPERIMENTAL

Paravertebral Block (PVB)

Intervention Type: 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.

A2 (Placebo)

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Ultrasonography and local infiltration of saline will only be performed

Interventions

Paravertebral Block (PVB)

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.

Intervention Type: OTHER

Saline

Ultrasonography and local infiltration of saline will only be performed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ben Chew, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ben Chew, MD,MSc,FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H10-02017

Identifier Type: -

Identifier Source: org_study_id