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Bladder NeoplasmNCT03458598

Pre-Operative Single Shot Rectus Sheath Block

A study testing Rectus sheath block and Bilateral rectus sheath catheter in people with Bladder Neoplasm and Prostate Neoplasm, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rectus sheath block and Bilateral rectus sheath catheter
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteCanada
Study dates
16 Feb 2018to 5 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta

    Edmonton, Alberta, T6G 2G3

Other trials in Canada

About this study

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

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.

Read the detailed description

Purpose: To improve analgesia and reduce opioid consumption in patients undergoing major urologic surgery.

Hypothesis: Patients receiving pre-operative single shot rectus sheath blockade in addition to continuous rectus sheath catheters will use less PCA opioid in the first 24 hours post-operatively compared to patients receiving continuous rectus sheath blockade for major urologic surgery.

Justification:

The sensorimotor innervation of the anterior abdominal wall is supplied by the ventral rami of the thoracolumbar spinal (T7-L1) segmental nerves. The thoracolumbar nerves course along the anterolateral wall within the transversus abdominis plane (TAP), and continue anteromedially, before entering the lateral aspect of the posterior rectus sheath. The nerves provide both muscular and cutaneous branches to innervate the muscle fibers and overlying skin with innervation from both left and right nerves supplying the midline. Regional anesthesia techniques for the anterior abdominal wall include both TAP and rectus sheath blocks.

The TAP block has been investigated extensively and shown to reduce opioid analgesia requirements post-operatively. The main difference between TAP block and rectus sheath block is that the rectus sheath block targets the nerves at a more anterior location. Bilateral rectus sheath nerve blocks are required to provide cover for midline incision and the investigators have previously described rectus sheath block with nerve catheter insertion under ultrasound guidance for midline laparotomy. A recent retrospective review from Dutton et al on the use of rectus sheath catheters for major urologic surgery reported that they offer an effective and safe method of peri-operative analgesia in patients undergoing major open urological pelvic surgery. Tudor et al demonstrated that rectus sheath catheters provide analgesia equivalent to that provided by epidurals following laparotomy for colorectal surgery.

At the University of Alberta Hospital, patients having major urologic surgery e.g. cystectomy have surgically placed rectus sheath catheters sited at the end of the procedure as a standard of analgesia care. This is combined with patient-controlled analgesia (PCA) opioid as part of a multimodal approach to post-operative pain control.

One disadvantage of surgically placed TAP and rectus sheath catheters is that they are inserted at the end of surgery. Therefore, the patient does not benefit from them intra-operatively and other methods of analgesia including opiates are required to reduce the sympathetic response to surgical stimulation and to prevent excessive immediate and early post-operative pain. The surgically placed rectus sheath catheters are sited during wound closure and then bolused with local anesthetic just prior to emergence so often the block is not fully established in the early post-operative period resulting in further opiate analgesia requirement.

The primary objective is to demonstrate that in patients undergoing major urologic surgery PCA opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had an ultrasound-guided 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 opiate requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including pain score in PACU and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation scores, time to first bowel movement, time to first mobilization and duration of hospital stay.

Research Methods: A randomized, double-blinded controlled trial.

Subjects who meet eligibility criteria will be invited to participate in the study by the clinical care team or research assistant in the Preadmission Clinic. Informed consent will be obtained by the research assistant. Next, all eligible participants will be randomized to the treatment group i.e. pre-operative single shot bilateral rectus sheath blocks + post-operative catheters or the control group i.e. post-operative catheters.

Randomization will be conducted through stratified-blocked randomization with varying blocks of 4 to 6 according to a schedule not known to the investigators using a computerized algorithm. The patient, intra-operative anesthetist, the surgeon and the assessor will be blinded to the randomization assignment.

The treatment group will have pre-operative single shot bilateral rectus blocks with 20 ml of a ropivacaine / bupivacaine mixture per side. The control group will have a pre-operative sham subcutaneous injection of 1ml saline per side. Both groups will have bilateral rectus sheath catheters placed surgically at the end of the procedure. Under direct visualization, the surgeon will insert a standard nerve block catheter between the rectus abdominis muscle and the posterior rectus sheath lateral to the incision on both sides. The catheter will be fixed to skin via a specialized taping system. An infusion of 0.2% ropivacaine will be administered through the rectus sheath catheter (1ml / hour continuous infusion with 15 ml /hour bolus every 4 hours). All patients will receive an IV morphine or dilaudid PCA and adjunctive post-operative medication. Intra-operative morphine / dilaudid administered intra-operatively will be recorded as well as total morphine / dilaudid used in the first 24 hours. Anesthesia technique will be standardized for short-acting opioid use i.e. fentanyl. Peri-operative multimodal analgesia adjuncts will include ketamine 0.2mg/kg and dexamethasone 6mg. All patients will be pre-medicated with acetaminophen 1g and gabapentin 300mg pre-operatively.

Primary and secondary outcomes will be collected by the study team from the patient chart and accompanying records and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test.

Being tested
Rectus sheath block, Bilateral rectus sheath catheter, Patient controlled opioid analgesia (PCA), Subcutaneous injection saline placebo
Medical subject headings
Urinary Bladder Neoplasms, Prostatic Neoplasms, Pelvic Neoplasms, Urologic Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rectus sheath blockProcedure or surgery

    Rectus sheath block under ultrasound

  • Bilateral rectus sheath catheterProcedure or surgery

    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 or surgery

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

Study groups in NCT03458598
Study groupRoleWhat they receive
Single shot rectus sheath blockExperimentalThe treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
Receives: Procedure: Rectus sheath block; Procedure: Bilateral rectus sheath catheter; Drug: Patient controlled opioid analgesia (PCA)
Placebo ControlSham comparatorThe control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
Receives: Procedure: Bilateral rectus sheath catheter; Drug: Patient controlled opioid analgesia (PCA); Procedure: Subcutaneous injection saline placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid requirement in first 24 hours after surgery

    Opioid requirement in first 24 hours after surgery

    Measured: 24 hours

Secondary outcomes (9)
  1. Intra-operative opioid requirement

    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.

    Measured: 3 - 6 hours

  2. (Numerical Rating Scale) NRS pain score at 24 and 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)

    Measured: 48 hours

  3. Severity of Nausea

    Rated as mild, moderate or severe by the patient

    Measured: 48 hours

  4. Number of vomiting episodes

    Number of discrete vomiting episodes per 24 hour period

    Measured: 48 hours

  5. Use of anti-emetics

    Name and total dose of anti-emetic per 24 hour period

    Measured: 48 hours

  6. Sedation score

    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).

    Measured: 48 hours

  7. Time to first bowel movement

    Time from end of surgery to first bowel movement.

    Measured: Up to 7 days

  8. Time to first mobilization

    Time from end of surgery to sitting on chair by bed

    Measured: 48 hours

  9. Duration of hospital stay

    Time from end of surgery to ready for discharge

    Measured: 7 - 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start16 Feb 2018
  3. Primary completion5 Feb 2019
  4. Study completion5 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03458598
Sponsor's protocol ID
Pro00078459
Status last verified
Jul 2022
First submitted
23 Feb 2018
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsui BC, Green JS, Ip VH. Ultrasound-guided rectus sheath catheter placement. Anaesthesia. 2014 Oct;69(10):1174-5. doi: 10.1111/anae.12849. No abstract available.

    PubMed 25204242
  • Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

    PubMed 19020158
  • Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

    PubMed 21296242
  • Dutton TJ, McGrath JS, Daugherty MO. Use of rectus sheath catheters for pain relief in patients undergoing major pelvic urological surgery. BJU Int. 2014 Feb;113(2):246-53. doi: 10.1111/bju.12316. Epub 2013 Aug 13.

    PubMed 23937574
  • Tudor EC, Yang W, Brown R, Mackey PM. Rectus sheath catheters provide equivalent analgesia to epidurals following laparotomy for colorectal surgery. Ann R Coll Surg Engl. 2015 Oct;97(7):530-3. doi: 10.1308/rcsann.2015.0018.

    PubMed 26414363

Questions about this trial

What is this clinical trial studying?

A study testing Rectus sheath block and Bilateral rectus sheath catheter in people with Bladder Neoplasm and Prostate Neoplasm, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid requirement in first 24 hours after surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03458598, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.

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