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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
Sponsor:
Information provided by (Responsible Party):
Ren Liao, West China Hospital

Tracking Information
First Submitted Date  ICMJE February 4, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
The incidence of postoperative CRBD [ Time Frame: 1 day ]
Patients complained about postoperative CRBD
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • 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" [17]. 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention
Official Title  ICMJE Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Catheter Site Discomfort
Intervention  ICMJE
  • 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
  • Drug: Intravenous tramadol
    Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation
    Other Name: Tramadol
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Bilateral pudendal nerve block
  • Active Comparator: The TRAM group
    Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation.
    Intervention: Drug: Intravenous tramadol
Publications * Li JY, Liao R. Prevention of catheter-related bladder discomfort - pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial. Trials. 2016 Sep 13;17(1):448. doi: 10.1186/s13063-016-1575-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18years to 75years.
  • American Society of Anesthesiologists (ASA) physical status I, II, or Ⅲ.
  • Undergoing elective prostate surgery at lithotomy position with urinary catheterization after anesthetic induction under general anesthesia.
  • Glasgow Coma Scale (GCS) score of 15. Ability to communicate.

Exclusion Criteria:

  • History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
  • History of bladder outflow obstruction.
  • Neurogenic bladder.
  • Impaired renal function.
  • Coagulopathy.
  • Known allergies to any anesthetic agent.
  • Family history of malignant hyperthermia.
  • Impairment of communication or cognition.
  • Psychopathy.
  • Active participation in another trial where the primary endpoint follow-up is ongoing.
  • Unwillingness or inability to comply with protocol procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683070
Other Study ID Numbers  ICMJE PNB2015-306
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is undecided whether to share IPD
Responsible Party Ren Liao, West China Hospital
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ren Liao, M.D. West China Hospital
PRS Account West China Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP