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Transversus Abdominis Plane Blocks With and Without Dexamethasone (TAP-DEX)

Primary Purpose

Colorectal Disorders, Regional Anesthesia Morbidity, Analgesia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Disorders focused on measuring perioperative analgesia, TAP block, laparoscopic surgery, regional anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age > 18
  • ASA class I-III
  • elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery.

Exclusion Criteria:

  • emergency surgery
  • open surgery
  • contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum)
  • ASA class 4
  • age < 18
  • pregnant or breastfeeding women
  • significant cardiorespiratory/hepatic/renal disease
  • allergy to any study drugs
  • inability to consent
  • inability to respond to pain assessments
  • inability to use the patient-controlled analgesia device (PCA)
  • preoperative chronic opioid use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Dexamethasone

    Local anesthetic only

    Arm Description

    Dexamethasone 16mg will be added to local anesthetic solution for TAP blocks. 4mg will be injected at 4 anterior abdominal wall sites in a laparoscopically-administered TAP block. This is a single intraoperative dose.

    Local anesthetic (bupivacaine 0.25) 1mL/kg will be used for TAP blocks.

    Outcomes

    Primary Outcome Measures

    Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.

    Secondary Outcome Measures

    Opioid consumption in the post-anesthetic care unit (PACU)
    Total opioid consumption during stay in the PACU, measured in hydromorphone equivalents.
    Length of stay in post-anesthetic care unit (minutes).
    Total duration of stay in PACU before transfer to the ward, measured in minutes. We anticipate a range of 60-120 minutes.
    Length of stay in hospital (days).
    Total hospital stay, measured in days. Usual range is 3-7 days.

    Full Information

    First Posted
    September 28, 2021
    Last Updated
    June 24, 2022
    Sponsor
    University of Saskatchewan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05432934
    Brief Title
    Transversus Abdominis Plane Blocks With and Without Dexamethasone
    Acronym
    TAP-DEX
    Official Title
    Transversus Abdominis Plane Blocks With and Without Dexamethasone: A Randomized Clinical Trial in Minimally Invasive Colorectal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    March 31, 2023 (Anticipated)
    Study Completion Date
    March 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Saskatchewan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Dexamethasone will be used as an adjunct to local anesthetics (bupivacaine) to prolong the duration of laparoscopically-placed transversus-abdominis plane blocks in elective colorectal resection.
    Detailed Description
    Advances in minimally invasive surgery have reduced postoperative morbidity and enhanced recovery. Despite increased use of minimally invasive techniques, postoperative pain remains a challenging aspect of surgical treatment of colorectal diseases and is typically treated with multimodal analgesia, yet the backbone of analgesia continues to be opioid therapy. As analgesics, opioids are effective but fraught with side effects, including delay in return of bowel function, sedation, and potential for dependency. Minimally invasive colorectal surgery has dramatically improved postoperative outcomes, resulting in significantly shorter length of stay, pain, and overall cost. Despite the advances in multimodal analgesia and enhanced-recovery pathways, the optimal strategy for perioperative analgesia has not yet been defined, and there may be a role for expanded use of regional anesthesia in minimally invasive surgery. Regional anesthesia, specifically the transversus abdominis plane block, has been shown to reduce postoperative pain and opioid requirements even in the context of minimally invasive surgery. Surgeon-performed, laparoscopically placed TAP blocks are equivalent, or perhaps superior, to ultrasound-guided TAP blocks . Long-acting local anesthetics, specifically liposomal bupivacaine, have been shown to prolong the effect of TAP blocks over non-liposomal bupivacaine , and has also suggested a reduced length of stay and less overall cost, despite the high cost of the formulation. These findings suggest improved outcomes can be expected if a longer block is achieved. Liposomal bupivacaine is not available and Canada and is very costly. Regional anesthetic supplemented with dexamethasone, a potent corticosteroid, has shown improved efficacy and prolonged duration of anesthetic in other regional anesthetic techniques. The investigators hypothesize that addition of dexamethasone to bupivacaine can prolong the duration of block to be similar to that achieved with liposomal bupivacaine, but at a much lower cost. Ample evidence exists validating TAP block as an effective adjunct to minimally invasive surgery. Robust data also support the additional benefit of dexamethasone in regional anesthesia. No studies have been published specifically assessing any benefit of combining dexamethasone with local anesthetic to improve the TAP block, and none can be found registered at clinicaltrials.gov. This will be the first such trial to evaluate a promising technique that could reduce postoperative pain and opioid requirements. If found to be effective, this technique would profoundly impact surgical practice around the world. The investigators propose a multi-centre randomized, single-blinded, controlled trial, enrolling 60 patients. Royal University Hospital in Saskatoon, Saskatchewan will be the primary site, with potential to include at least one additional site. Planning is currently underway to run a second trial site at St. Paul's Hospital, Vancouver, British Columbia. The study investigators maintain a collaborative research relationship with the Division of Colorectal Surgery at the University of British Columbia, and there is potential to leverage this relationship to increase the power and relevance of the trial. Patients older than 18 years scheduled to undergo elective or urgent inpatient minimally invasive colorectal resection will be recruited. The type and site of extraction incision will be at the surgeon's preference. Exclusion criteria include conversion to laparotomy, perforated viscus, peritonitis, acute diverticulitis, death within 72 hours, and preoperative opioid use. The primary outcome will be total opioid consumption in the first 48 hours after surgery. Secondary outcomes will be time in the PACU and length of stay in hospital. A computer-generated random number table will be used to randomize patients to receive either conventional TAP (n=30) or TAP-DEX (n=30). Allocation will be performed in a 1:1 ratio. Group allocation will be revealed to the operating surgeon in order to administer the correct solution, but blinded to patient and study investigators, PACU staff, and ward staff. Trial participants will undergo their planned procedures as clinically indicated. Eligible procedures include laparoscopic low anterior resection, anterior resection, and segmental colectomy. At completion of the surgery, patients will undergo surgeon-placed laparoscopic TAP blocks using 1mL/kg of 0.25% bupivacaine with epinephrine 1:200,000, placed at two locations per side along the anterior axillary line between the costal margin and the iliac crest. The dexamethasone group will have 16mg dexamethasone added to the solution. Intravenous dexamethasone will not be given for prevention of postoperative nausea and vomiting. General anesthetic technique will be at the preference of the anesthesiologist. Statistical Analysis Data collection: A blinded, centralized, third-party research assistant will carry out data collection. Postoperative opioid consumption will be quantified through chart review as well as assessment of PCA usage 48 hours following the operation. Recording the doses of opioids administered in the medication administration record (MAR) is standard practice by PACU nursing staff at the study institution. PCA pumps automatically document cumulative opioids administered and can easily be checked at the bedside. Data will be entered and recorded into an encrypted Microsoft Excel spreadsheet. The study intends to enroll a sample size of 60 patients, with 30 patients in each group, using a power of 80% and alpha set at 5%, to detect a detect a difference of 25% (delta=-0.25) under a normal distribution. Given that the standard deviation of 1 is 0.341 under a normal distribution, the sample size was calculated using a 'power of two means" test with a commercially available software (STATA ®). This same sample size, and power calculation, has been used in several trials before . There is an anticipated reduction from 32mg hydromorphone equivalents in the TAP group to less than 25mg in the TAP-DEX group. Thus, the investigators are confident that enrolling 60 patients will be sufficient to detect at least a 25% difference. Primary outcome: The primary outcome will be total opioid use, in morphine equivalents, in the post-anesthetic recovery unit and the first 48 hours after surgery, Opioid equivalents will be calculated using http://opioidcalculator.practicalpainmanagement.com/conversion.php. Secondary Outcome: Secondary outcomes will include time of stay in the PACU and length of stay in hospital. An interim analysis will be performed after 50% enrolment for evaluation of superiority of either treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Disorders, Regional Anesthesia Morbidity, Analgesia, Local Anesthetic Complication, Pain, Postoperative, Colorectal Cancer, Crohn Disease, Diverticular Diseases
    Keywords
    perioperative analgesia, TAP block, laparoscopic surgery, regional anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone
    Arm Type
    Experimental
    Arm Description
    Dexamethasone 16mg will be added to local anesthetic solution for TAP blocks. 4mg will be injected at 4 anterior abdominal wall sites in a laparoscopically-administered TAP block. This is a single intraoperative dose.
    Arm Title
    Local anesthetic only
    Arm Type
    No Intervention
    Arm Description
    Local anesthetic (bupivacaine 0.25) 1mL/kg will be used for TAP blocks.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone will be added to local anesthetic solution and injected at 4 site for for laparoscopically placed TAP blocks.
    Primary Outcome Measure Information:
    Title
    Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Opioid consumption in the post-anesthetic care unit (PACU)
    Description
    Total opioid consumption during stay in the PACU, measured in hydromorphone equivalents.
    Time Frame
    48 hours
    Title
    Length of stay in post-anesthetic care unit (minutes).
    Description
    Total duration of stay in PACU before transfer to the ward, measured in minutes. We anticipate a range of 60-120 minutes.
    Time Frame
    60-120 minutes
    Title
    Length of stay in hospital (days).
    Description
    Total hospital stay, measured in days. Usual range is 3-7 days.
    Time Frame
    3-7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age > 18 ASA class I-III elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery. Exclusion Criteria: emergency surgery open surgery contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum) ASA class 4 age < 18 pregnant or breastfeeding women significant cardiorespiratory/hepatic/renal disease allergy to any study drugs inability to consent inability to respond to pain assessments inability to use the patient-controlled analgesia device (PCA) preoperative chronic opioid use
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David N Ginther, MD
    Phone
    306-655-6893
    Email
    n.ginther@usask.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David N Ginther, MD
    Organizational Affiliation
    University of Saskatchewan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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