CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Patient controlled opioid analgesia (PCA) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03458598
NCT03458598N/ACompleted

Measuring the Analgesic Effect of Adding Pre-Operative Single Shot Rectus Sheath Blocks to Post-Operative Rectus Sheath Continuous Blocks for Major Urologic Surgery: A Randomized Controlled Trial

University of Alberta·interventional·Posted Mar 8, 2018·Updated Jul 28, 2022

In Brief

A clinical study evaluating Rectus sheath block, Bilateral rectus sheath catheter, and 2 other interventions for Bladder Neoplasm and 6 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed Summary

Objectives The primary objective is to demonstrate that in patients undergoing major urologic surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had a single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block. Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score, time to first bowel movement, time to first mobilization and duration of hospital stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 8, 2018
Enrollment StartFeb 16, 2018
Primary CompletionFeb 5, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.3 years ago

Interventions

Rectus sheath blockprocedure

Rectus sheath block under ultrasound

Bilateral rectus sheath catheterprocedure

A nerve block catheter known as a continuous rectus sheath block is inserted by the surgeon at the end of the operation. An infusion of 0.2% ropivacaine is delivered through this for up to 48 hours post-operatively.

Patient controlled opioid analgesia (PCA)drug

Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.

Subcutaneous injection saline placeboprocedure

Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed