Open Nephrectomy Surgery
Conditions
Brief summary
This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.
Detailed description
QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear. Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.
Interventions
PROCEDUREQuadratus lumborum block
Quadratus lumborum (QL) block for open partial nephrectomy.
PROCEDUREEpidural analgesia
Epidural analgesia for open partial nephrectomy.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Adults having for open unilateral partial nephrectomy surgery.
Exclusion criteria
1\. Pregnancy 2. Intolerance or allergy to opioids 3. Previous radical nephrectomy surgery/midline incision 4. Contraindication to epidural analgesia 5. Contraindications to QL block 6. Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | Arrival to post anesthesia care unit until 72 hours after surgery | Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery. |
| Postoperative pain | Arrival to post anesthesia care unit until 72 hours after surgery | Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment | Three days after surgery | Patient global assessment of pain control is measured on an ordinal scale by the patient. Patients can rate their pain control as poor, fair, good, or excellent. |
| Doses of antiemetic medications administered | Arrival to post anesthesia care unit until the third day after surgery | Count of the number of antiemetic medications administered. |
| Duration of postoperative hospitalization | From the date of surgery to hospital discharge, assessed up to 12 months. | Duration of postoperative hospitalization |
| Episodes of hypotension | Arrival to post anesthesia care unit until the third day after surgery | Number of episodes of hypotension during hospital stay, defined by MAP less than 65 mmHg requiring intervention. |
Countries
United States
Outcome results
None listed