Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03154658 |
| Other study ID # |
STU 122016-011 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
March 1, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a randomized, interventional prospective study. Patients (n=66) undergoing
mastectomies with or without tissue expander will be randomized to receive a supra-serratus
or sub-serratus regional plane block prior to surgery. The main effect to be measured is
total opioid consumption 24 hours after the operation. Secondary endpoints include measuring
a change between pre-and post-operative pain scores, patient satisfaction of pain control
during first 24 hours after the operation, presence of postoperative nausea and vomiting,
duration of sleep on first postoperative night, and block performance time and length of
stay, between the two treatment arms.
Description:
Subjects will be randomized to one of two groups: the supra-serratus anterior plane block
(depositing local anesthetic superficial to the serratus anterior muscle) or the sub-serratus
anterior plane block (depositing local anesthetic deep to the serratus anterior muscle).
Randomization will be performed using a computer generated randomization program. The results
of the randomization will be revealed to the physician performing the block just prior to its
performance. The site of the block will be marked and a safety timeout will be performed with
the block nurse, regional anesthesiologist, and patient present and participating.
Once the above is completed, patients will receive a pre-operative ultrasound-guided
single-injection serratus anterior plane block using either the supra-serratus or
sub-serratus techniques according to their randomization. The block nurse will record the
time when the timeout is performed, the "needle insertion" time when the block needle enters
the skin, and the "block complete" time when the needle exits the skin. If the block is
bilateral, the block nurse will record the time when the timeout is performed, then will
record two sets of "needle in" times and "needle out" times, one for each side. In the case
of a bilateral block, the same method of serratus anterior plane block will be utilized for
both sides.
After the block, the patient will proceed to surgery. The operating room anesthesia team will
be notified that the patient received a serratus anterior plane block. An appropriate
multimodal general anesthetic will be employed at the operating room anesthesiologist's
discretion. Upon completion of the surgery and emergence from general anesthesia, the patient
will be seen by study personnel in the Post Anesthesia Care Unit and pain will be evaluated
using a 0-10 Likert scale (0=no pain, 10= worst imaginable pain) about 1 hour
post-operatively. Pain will be evaluated again by study personnel using the same scale on
post-operative day #1, about 24 hours after initial block placement. If the patient is
discharged home prior to the post-operative day #1 assessment, a phone interview will be
performed 24 hours following the block to evaluate the post-operative day #1 scores and
monitor for adverse events. Additional pain scores will be documented in the electronic
medical record by nursing staff per protocol, and will be collected by study personnel.
During the intraoperative and post-operative period, the patient will continue to receive an
appropriate multimodal analgesic regimen as necessary to adequately control the pain. No pain
control method will be withheld from the patient as a result of participating in the study.
Patient satisfaction scores will also be used as a measure to evaluate quality of
perioperative pain management. These scores will be assessed on post-operative day #1 on a
scale of 1 to 5 (Poor=1, Fair=2, Good=3 Very good=4, Excellent=5).
During follow-up on post-operative day #1, the patients will also be asked for an estimate on
duration and quality of sleep to help assess their general comfort level during their first
post-operative night.
During the routine post-operative visit, an assessment of post-operative nausea and vomiting
will be made by asking the patient directly. Chart review looking for post-operative
antiemetic usage will also be evaluated to assess the presence of post-operative nausea and
vomiting.
The decision as to whether or not to perform a serratus anterior plane block (SAPB) will be
made independent from the introduction of the patient to the study. Therefore, the patient's
choice to receive a SAPB will not be affected by the introduction of the study or their
desire to participate in a clinical investigation. A multimodal intraoperative anesthetic
technique will be employed for all patients, and post-operative pain control will be managed
by the patient's primary surgical team.
