Ignite Creation Date:
2024-05-06 @ 8:12 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02683070
Status:
UNKNOWN
Last Update Posted:
2016-02-17
First Post:
2016-02-04
Brief Title:
Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort a Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Catheter-related bladder discomfort CRBD is not uncommon in male patients under general anesthesia and it may cause patient agitation and exacerbated postoperative pain In this study the investigators will enroll male patients undergoing elective prostate surgery with urinary catheterization after anesthetic induction and compare the efficacy of pudendal nerve block PNB and intravenous tramadol in prevention of CRBD
Detailed Description:
The PNB trial is an investigator-initiated prospective randomized controlled trial that will test the superiority of pudendal nerve block with 033 ropivacaine to intravenous tramadol 15mgkg for CRBD prevention A total of 94 patients undergoing elective prostate surgery at lithotomy position with urinary catheterization 16 G Fr Foley catheter after anesthetic induction under general anesthesia will be enrolled at West China Hospital of Sichuan University Patients will be divided randomly into two groups
The PNB group patients will be given bilateral pudendal nerve block with 30ml of 033 ropivacaine 15ml for each side after the completion of surgery before extubation
The TRAM group patients will be given tramadol of 15mgkg after the completion of surgery before extubation
All patients will be evaluated by a research nurse who were blinded to the group assignments for outcomes at 0 1 2 4 and 6h after patients arrival in PACU and after extraction of urinary catheter
The primary outcome is the incidence of postoperative CRBD The secondary outcomes include the severity of postoperative CRBD postoperative tramadol requirement and number of patients with requiring postoperative tramadol numeric rating scale NRS for postoperative pain postoperative sufentanil requirement and number of patients with requiring postoperative sufentanil postoperative side effects and acceptance of indwelling urinary catheter after extraction of the catheter
All primary and secondary endpoints will be analyzed on an intent-to-treat basis Analyses are performed with the use of SPSS 180 software The Student-t test is used to analyze demographic data in the two groups The incidence of CRBD and side effects between groups are analyzed by Chi-square test whereas the severity of CRBD mild moderate and severe is analyzed by Fishers exact test NRS scale is analyzed by the Mann-Whitney test Postoperative tramadol and sufentanil requirement is analyzed by Z test and the number of patients requiring tramadol for CRBD rescue treatment and sufentanil for postoperative pain will be analyzed with Fishers exact test A P value005 is considered significant
The PNB group patients will be given bilateral pudendal nerve block with 30ml of 033 ropivacaine 15ml for each side after the completion of surgery before extubation
The TRAM group patients will be given tramadol of 15mgkg after the completion of surgery before extubation
All patients will be evaluated by a research nurse who were blinded to the group assignments for outcomes at 0 1 2 4 and 6h after patients arrival in PACU and after extraction of urinary catheter
The primary outcome is the incidence of postoperative CRBD The secondary outcomes include the severity of postoperative CRBD postoperative tramadol requirement and number of patients with requiring postoperative tramadol numeric rating scale NRS for postoperative pain postoperative sufentanil requirement and number of patients with requiring postoperative sufentanil postoperative side effects and acceptance of indwelling urinary catheter after extraction of the catheter
All primary and secondary endpoints will be analyzed on an intent-to-treat basis Analyses are performed with the use of SPSS 180 software The Student-t test is used to analyze demographic data in the two groups The incidence of CRBD and side effects between groups are analyzed by Chi-square test whereas the severity of CRBD mild moderate and severe is analyzed by Fishers exact test NRS scale is analyzed by the Mann-Whitney test Postoperative tramadol and sufentanil requirement is analyzed by Z test and the number of patients requiring tramadol for CRBD rescue treatment and sufentanil for postoperative pain will be analyzed with Fishers exact test A P value005 is considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None