Breast Cancer
Conditions
Brief summary
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.
Detailed description
Breast reconstruction after mastectomy has seen continued growth and popularity in recent years secondary to improved surgical techniques and improved patient awareness and understanding. While implant-based reconstruction remain the most popular option, autologous tissue transfer, reconstruction of the breast with a patient's own tissues, has emerged as the gold standard for breast reconstruction, most commonly performed with abdominally-based flaps, such as the deep inferior epigastric perforator (DIEP) flap. Postoperative pain can be a difficult challenge in patients who have undergone DIEP flap. Patients with worse postoperative pain control report worse overall satisfaction with their surgical experience. A multimodal analgesia protocol is a key component in the postoperative care after DIEP flap. Regional nerve blocks present an adjunct to these protocols that can potentially improve the quality of recovery of these patients. Transversus abdominus plane (TAP) blocks have been shown to be a safe and effective technique to manage postoperative pain at the abdomen in this population; lowering usage of opiates, shortening length of stay and reducing episodes of nausea and vomiting. TAP's efficacy is well-established and documented for postoperative analgesia in abdominal surgery. This can be done preoperatively by an anesthetist via ultrasound-guidance or, using traditional technique of direct visualization, intraoperatively by the operating surgeon. Surgeon-performed intra-operative TAP block are often preferred as it is less time-consuming. TAP block has become the standard abdominal regional nerve block to perform during this procedure. More recently, QL block has emerged as an alternative to TAP block for lower abdominal surgery. The QL block is an ultrasound-guided fascial plane block performed by an anesthetist for anterior abdominal wall analgesia. This study will compare QL block to TAP block in patients undergoing DIEP free flap breast reconstruction.
Interventions
PROCEDURETAP block
Please see description of TAP block group.
PROCEDUREQL Block
Please see description of QL block group.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patients will be randomized by using forty-six sealed, opaque envelopes to receive a TAP block or QL block. This is a double-blind study. Patient, surgeon and study staff will know which group patient has been assigned to. The anesthetist will know which group you are in for logistical purposes. The patient and surgeon will not know which nerve block the patient received.
Intervention model description
Patients will be randomized to receive intraoperative TAP block (Group A) or preoperative ultrasound- guided QL block (Group B).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women (age 18 years or older) who are booked for abdominally based free flap for breast reconstruction * Patients with America Society of Anesthesiologists (ASA) physical status class I, II and III
Exclusion criteria
* Patients not consenting for regional block * Patients allergic to local anesthetics and adjuvants * Patients with America Society of Anesthesiologists (ASA) physical status class IV and V * Patients with any baseline opiate consumption * Presence of infection at needle insertion site * Patients with coagulopathy (INR\>1.3) * Patients with thrombocytopenia (Platelets\<100) * Patients on therapeutic anticoagulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 survey | post-operative day #1 | Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 1. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation | post-operative day #0 to 3 | Ability of patient to ambulate (e.g. up to chair, mobilizing with assistance, mobilizing independently) in the first 3 days after surgery. |
| Surgical complication | post-operative day #0 to 3 | Any acute surgical complications experienced by the patient in the first three days after surgery. |
| Quality of Recovery-15 survey | post-operative day #2 | Quality of Recovery-15 (QoR-15) survey is a validated 15-item patient-rated postoperative recovery score, will be obtained on postoperative day (POD) 2. Survey results are a numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). Higher scores are a better outcome. |
| Total antiemetic drug requirements | post-operative day #0 to 3 | The total amount of antiemetic medication patient requires in the first 3 days after surgery |
| Time elapsed before first analgesic requirement | post-operative day #0 to 3 | Time that has elapsed since surgery before first analgesic medication is needed. |
| Total analgesic drug requirements | post-operative day #0 to 3 | The total amount of analgesic medication patient requires in the first 3 days after surgery |
| Block complication | post-operative day #0 to 3 | Any acute nerve-block related complications experienced by the patient in the first three days after surgery. |
| Pain visual analog scale | 1st, 2nd, 4th, 8th, 12th, 16th and 24th postoperative hours | Pain visual analog scale (VAS) is a 1 to 10 continuous scale used to determine the intensity of a patient's pain at any given time. For any given time, the minimum value is 1 (no pain) and the maximum value is 10 (pain as bad as it could possibly be). The lower the number, the less intense the pain and better outcome. |
Countries
Canada
Outcome results
None listed