TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
Condition: Transversus Abdominis Plane (TAP) Block Catheter; DIEP or Free MS-TRAM Breast Reconstruction; Local Pain Management; Abdominal/ Donor Site
Intervention: Bupivacaine (study group); Isotonic saline (control group)
Intervention description: At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.; At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Breast reconstruction using a patient's own abdominal tissue is one of the most common
      methods for restoring mastectomy defects for breast cancer patients. Despite its increasing
      popularity and safety, the abdomen remains a major source of postoperative pain. Adequate
      pain control is important as it has been shown to reduce medical complications, in-hospital
      death, shortens hospital stay, lessen chronic pain and disability, and in turn lower
      health-care costs. The current postoperative pain relief protocol consists primarily of a
      patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause
      numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties,
      bladder and bowel dysfunction. A promising approach to provide postoperative pain control of
      the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral
      nerve block. Although the TAP block has been found to be an effective pain-relief following
      major abdominal surgeries, its use has never been studied for breast reconstruction using
      abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a
      TAP block in reducing postoperative abdominal pain following abdominal tissue breast
      reconstruction. This study has significant implications in improving both clinical care and
      health outcomes in patients undergoing this common method of breast reconstruction technique.
    

Eligibility criteria:

        Inclusion Criteria:

        -Pre-operative eligibility:

          -  Patients above the age of 18, no upper age limit

          -  English-speaking

          -  Delayed reconstruction (mastectomy already performed) or immediate reconstruction
             (mastectomy at the same time as reconstruction)

          -  Reconstruction using abdominal tissues including free MS-TRAM or DIEP

        Exclusion Criteria:

          -  Patient refusal

          -  Inability to give informed consent

          -  BMI > 40

          -  Allergy to Bupivacaine

          -  Known cardiac or liver disease (contraindicated for Bupivacaine use)

          -  Patients who will undergo any of the following:

               -  Implant breast reconstruction

               -  Combined implant and autologous tissue reconstruction

               -  Non-abdominally based autologous tissue reconstruction

               -  Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)

          -  Drug addiction

          -  Opioid tolerance defined as preoperative opioid use of >50 mg PO morphine equivalent

          -  Psychiatric illness