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Pre-Operative Single Shot Rectus Sheath Block

Primary Purpose

Bladder Neoplasm, Prostate Neoplasm, Pelvic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rectus sheath block
Bilateral rectus sheath catheter
Patient controlled opioid analgesia (PCA)
Subcutaneous injection saline placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Single shot rectus sheath block

Placebo Control

Arm Description

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.

The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.

Outcomes

Primary Outcome Measures

Opioid requirement in first 24 hours after surgery
Opioid requirement in first 24 hours after surgery

Secondary Outcome Measures

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.
(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)
Severity of Nausea
Rated as mild, moderate or severe by the patient
Number of vomiting episodes
Number of discrete vomiting episodes per 24 hour period
Use of anti-emetics
Name and total dose of anti-emetic per 24 hour period
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).
Time to first bowel movement
Time from end of surgery to first bowel movement.
Time to first mobilization
Time from end of surgery to sitting on chair by bed
Duration of hospital stay
Time from end of surgery to ready for discharge

Full Information

First Posted
February 23, 2018
Last Updated
July 25, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03458598
Brief Title
Pre-Operative Single Shot Rectus Sheath Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasm, Prostate Neoplasm, Pelvic Neoplasm, Urologic Neoplasms, Opioid Use, Anesthesia, Local, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The intra-operative anesthesiologist, surgeon and outcomes assessor are blinded to group allocation
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single shot rectus sheath block
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control
Arm Type
Sham Comparator
Arm Description
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
Intervention Type
Procedure
Intervention Name(s)
Rectus sheath block
Intervention Description
Rectus sheath block under ultrasound
Intervention Type
Procedure
Intervention Name(s)
Bilateral rectus sheath catheter
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Patient controlled opioid analgesia (PCA)
Intervention Description
Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.
Intervention Type
Procedure
Intervention Name(s)
Subcutaneous injection saline placebo
Intervention Description
Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed
Primary Outcome Measure Information:
Title
Opioid requirement in first 24 hours after surgery
Description
Opioid requirement in first 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intra-operative opioid requirement
Description
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.
Time Frame
3 - 6 hours
Title
(Numerical Rating Scale) NRS pain score at 24 and 48 hours
Description
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)
Time Frame
48 hours
Title
Severity of Nausea
Description
Rated as mild, moderate or severe by the patient
Time Frame
48 hours
Title
Number of vomiting episodes
Description
Number of discrete vomiting episodes per 24 hour period
Time Frame
48 hours
Title
Use of anti-emetics
Description
Name and total dose of anti-emetic per 24 hour period
Time Frame
48 hours
Title
Sedation score
Description
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).
Time Frame
48 hours
Title
Time to first bowel movement
Description
Time from end of surgery to first bowel movement.
Time Frame
Up to 7 days
Title
Time to first mobilization
Description
Time from end of surgery to sitting on chair by bed
Time Frame
48 hours
Title
Duration of hospital stay
Description
Time from end of surgery to ready for discharge
Time Frame
7 - 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25204242
Citation
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.
Results Reference
background
PubMed Identifier
19020158
Citation
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.
Results Reference
background
PubMed Identifier
21296242
Citation
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.
Results Reference
background
PubMed Identifier
23937574
Citation
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.
Results Reference
background
PubMed Identifier
26414363
Citation
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.
Results Reference
background

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Pre-Operative Single Shot Rectus Sheath Block

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