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Trial record 56 of 451 for:    TRAMADOL

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

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  1. The incidence of postoperative CRBD [ Time Frame: 1 day ]
    Patients complained about postoperative CRBD


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Incidences of postoperative side effects [ Time Frame: 1 day ]
    Side effects include postoperative nausea/vomiting (PONV), dizziness, sedation, and dry mouth.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ren Liao, M.D. +86-18980602177 liaoren7733@163.com

Locations
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China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Ren Liao, M.D. West China Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ren Liao, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT02683070     History of Changes
Other Study ID Numbers: PNB2015-306
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is undecided whether to share IPD
Keywords provided by Ren Liao, West China Hospital:
Catheter-related bladder discomfort
Pudendal nerve block
Tramadol
Randomized controlled trial
catheter-related bladder discomfort prevention
Additional relevant MeSH terms:
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Tramadol
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics