Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention
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|ClinicalTrials.gov Identifier: NCT02683070|
Recruitment Status : Unknown
Verified February 2016 by Ren Liao, West China Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Catheter Site Discomfort||Procedure: Bilateral pudendal nerve block Drug: Intravenous tramadol||Not Applicable|
The PNB trial is an investigator-initiated, prospective, randomized controlled trial that will test the superiority of pudendal nerve block with 0.33% ropivacaine to intravenous tramadol 1.5mg/kg 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 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation.
The TRAM group: patients will be given tramadol of 1.5mg/kg 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 18.0 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 Fisher's 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 Fisher's exact test. A P value<0.05 is considered significant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: The PNB group
Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) will be performed after the completion of surgery before extubation.
Procedure: Bilateral pudendal nerve block
Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation
Other Name: Ropivacaine
Active Comparator: The TRAM group
Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation.
Drug: Intravenous tramadol
Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation
Other Name: Tramadol
- The incidence of postoperative CRBD [ Time Frame: 1 day ]Patients complained about postoperative CRBD
- The severity of postoperative CRBD [ Time Frame: 1 day ]It's assessed according to the following scaling system: no CRBD indicates that there are no complaints of CRBD at all; mild indicates that complaints of CRBD exist only if the patient was asked about it; moderate indicates that patients complain of CRBD spontaneously; and severe indicates that CRBD causes a spontaneous behavioral response such as flailing limb, strong vocal response, or attempt to pull out the catheter.
- Postoperative tramadol requirement [ Time Frame: 1 day ]When moderate or severe CRBD is reported, intravenous tramadol 1.5mg/kg will be administered as a rescue treatment to reduce the bladder discomfort, and tramadol requirement will be recorded and compared.
- Numeric rating scale (NRS) for postoperative pain. [ Time Frame: 1 day ]Patients will be asked for evaluating pain intensity by themselves using this single 11-point numeric scale ranged between 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain" . If the patient complains about pain with NRS greater than 4, intravenous sufentanil 5 μg will be administered as rescue analgetic treatment.
- Postoperative sufentanil requirement [ Time Frame: 1 day ]Intravenous sufentanil 5 μg will be administered as rescue analgetic treatment for postoperative pain, and sufentanil requirementwill be recorded and compared.
- Incidences of postoperative side effects [ Time Frame: 1 day ]Side effects include postoperative nausea/vomiting (PONV), dizziness, sedation, and dry mouth.
- Acceptance of indwelling urinary catheter after extraction of the catheter [ Time Frame: 1 week ]Patients will be asked to answer the question "Will you worry about urinary catheterization if you undergo another operation next time?". The answer "No" meant acceptance of indwelling urinary catheter, and the answer "Yes" meant unacceptance of indwelling urinary catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683070
|Contact: Ren Liao, M.D.||+firstname.lastname@example.org|
|West China Hospital, Sichuan University|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Ren Liao, M.D.||West China Hospital|