Post-operative Pain
Conditions
Keywords
TAP block, incision pain, total hysterectomy
Brief summary
Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.
Detailed description
Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.
Interventions
DRUGRopivacaine
20mLs of 0.5%
Sponsors
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18-70 years old * total abdominal hysterectomy * capable of completing informed consent * no previous chronic opioid use * no previous abdominal wall surgeries
Exclusion criteria
* patient refusal * contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, * local or systemic infection * local anesthetic allergy * BMI\>35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume. | 6 month | This will be shown as a number and a percenttage of patients recruited and randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block. | 48 hours | The assessor will measure the extend of the block distribution at the various time intervals. |
| Pain scores at 2,6,12,24, and 48 hours post-block. | 48 hours | Using a visual analog scale, patient pain scores will be assessed. |
| Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block. | 48 hours | Record drug consumption at the time intervals |
| Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours. | 48 hours | — |
| Block failure rate. | 48 hours | Block failure rate is defined as the lack of any sensory block following the TAP block. |
| Patient's overall satisfaction. | 48 hours | Using a LIKERT score, patient satisfaction will be measured. |
| Discharge time from PACU. | 24 hours | The time in which the patient is discharged from the recovery room. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMauricio Forero, MD
McMaster University/St. Joseph's Healthcare
Outcome results
None listed