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Pre-Operative Single Shot Rectus Sheath Block

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ClinicalTrials.gov Identifier: NCT03458598
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Derek Dillane, University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Neoplasm Prostate Neoplasm Pelvic Neoplasm Urologic Neoplasms Opioid Use Anesthesia, Local Pain, Postoperative Procedure: Rectus sheath block Procedure: Bilateral rectus sheath catheter Drug: Patient controlled opioid analgesia (PCA) Procedure: Subcutaneous injection saline placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The intra-operative anesthesiologist, surgeon and outcomes assessor are blinded to group allocation
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: Single shot rectus sheath block
The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
Procedure: Rectus sheath block
Rectus sheath block under ultrasound

Procedure: Bilateral rectus sheath catheter
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.

Drug: Patient controlled opioid analgesia (PCA)
Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.

Sham Comparator: Placebo Control
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
Procedure: Bilateral rectus sheath catheter
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.

Drug: Patient controlled opioid analgesia (PCA)
Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.

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




Primary Outcome Measures :
  1. Opioid requirement in first 24 hours after surgery [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Intra-operative opioid requirement [ Time Frame: 3 - 6 hours ]
    Surgery times vary but on average the procedure being investigated takes 3 - 6 hours. Opioid administered during this time by the intra-operative anesthesiologist will be recorded for the study.

  2. (Numerical Rating Scale) NRS pain score at 24 and 48 hours [ Time Frame: 48 hours ]
    The NRS pain scale is a used to measure pain intensity. Patients are asked to rate their pain between 0 (no pain) and 10 (worst pain possible)

  3. Severity of Nausea [ Time Frame: 48 hours ]
    Rated as mild, moderate or severe by the patient

  4. Number of vomiting episodes [ Time Frame: 48 hours ]
    Number of discrete vomiting episodes per 24 hour period

  5. Use of anti-emetics [ Time Frame: 48 hours ]
    Name and total dose of anti-emetic per 24 hour period

  6. Sedation score [ Time Frame: 48 hours ]
    Patients will be rated as alert, drowsy, light sedation i.e. awakens with eye contact), moderate sedation (wakens to voice), deep sedation (wakes to physical stimulation but not to voice) and unrousable (no response to voice or physical stimulation).

  7. Time to first bowel movement [ Time Frame: Up to 7 days ]
    Time from end of surgery to first bowel movement.

  8. Time to first mobilization [ Time Frame: 48 hours ]
    Time from end of surgery to sitting on chair by bed

  9. Duration of hospital stay [ Time Frame: 7 - 14 days ]
    Time from end of surgery to ready for discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients over 18 years
  • Undergoing major urological surgery
  • Consent to a rectus sheath blockade as part of their postoperative management

Exclusion Criteria:

  • Patients under 18 years
  • Local or systemic infection
  • Patients who refuse consent
  • Opioid tolerance
  • History of chronic pain
  • Psychiatric illness
  • Allergy to local anesthetic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458598


Contacts
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Contact: Derek Dillane, FCARCSI 7804078600 dillane@ualberta.ca
Contact: Michelle Verrier 7804078600

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Derek Dillane, MB    7804078600    dillane@ualberta.ca   
Sponsors and Collaborators
University of Alberta

Publications:
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Responsible Party: Derek Dillane, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03458598     History of Changes
Other Study ID Numbers: Pro00078459
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Pain, Postoperative
Urinary Bladder Neoplasms
Prostatic Neoplasms
Urologic Neoplasms
Pelvic Neoplasms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases