Pudendal Nerve Block for Catheter-related Bladder Discomfort Prevention

Catheter Site Discomfort Clinical Trial

Official title:

Comparison of Pudendal Nerve Block With Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02683070
• Other study ID #: PNB2015-306
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: February 11, 2016
• Start date: March 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2016
• Source: West China Hospital
• Contact: Ren Liao, M.D.
• Phone: +86-18980602177
• Email: liaoren7733[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged 18years to 75years.

• American Society of Anesthesiologists (ASA) physical status I, II, or ?.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheter Site Discomfort

Intervention

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

Drug:
• Intravenous tramadol
Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative CRBD	Patients complained about postoperative CRBD	1 day	No
Secondary	The severity of postoperative CRBD	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.	1 day	No
Secondary	Postoperative tramadol requirement	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.	1 day	No
Secondary	Numeric rating scale (NRS) for postoperative pain.	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.	1 day	No
Secondary	Postoperative sufentanil requirement	Intravenous sufentanil 5 µg will be administered as rescue analgetic treatment for postoperative pain, and sufentanil requirementwill be recorded and compared.	1 day	No
Secondary	Incidences of postoperative side effects	Side effects include postoperative nausea/vomiting (PONV), dizziness, sedation, and dry mouth.	1 day	No
Secondary	Acceptance of indwelling urinary catheter after extraction of the catheter	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.	1 week	No