Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention

Sponsor

West China Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02683070

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Site Discomfort	Procedure: Bilateral pudendal nerve block Drug: Intravenous tramadol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Mar 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Tramadol

Arm

Intervention/Treatment

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 Names:

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 Names:

Tramadol

Outcome Measures

Primary Outcome Measures

The incidence of postoperative CRBD [1 day]
Patients complained about postoperative CRBD

Secondary Outcome Measures

The severity of postoperative CRBD [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 [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. [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 [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 [1 day]
Side effects include postoperative nausea/vomiting (PONV), dizziness, sedation, and dry mouth.
Acceptance of indwelling urinary catheter after extraction of the catheter [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.