Post Operative Urinary Retention Clinical Trial
Official title:
The Use of Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair: A Randomized Double-Blind Placebo-Controlled Study
To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.
Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented
in the office by the attending physician. An order will be placed during surgery scheduling
for tamsulosin with instruction to administer one dose in the preoperative holding area on
the day of surgery. The Jewish hospital pharmacy will be responsible for providing
randomization and placebo medications for double blinding effect. PUR will be tracked on the
basis of urinary catheterization performed prior to hospital discharge. Criteria for
catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder
scan showing >400 mL. ii) Inability to urinate at any time postoperatively with symptoms of
urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to
have a confirmed negative urine or serum pregnancy test prior to surgery. This will be
completed on arrival to the preoperative holding area.
To detect the difference between the treated group and control group with a significant alpha
(0.5) and power (80%), at least 178 patients will be needed in each group. This was generated
using the Pearson Chi-square test for Two proportions.
This study will be conducted in the hospital setting at a single institution. Patients will
be consented for the study in the pre-admission holding area and followed until discharged
from the post anesthesia care unit.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02414373 -
Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function
|
Phase 4 |