NCT02683070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

February 4, 2016

Last Update Submit

February 11, 2016

Conditions

Catheter Site Discomfort

Keywords

Catheter-related bladder discomfortPudendal nerve blockTramadolRandomized controlled trialcatheter-related bladder discomfort prevention

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative CRBD

    Patients complained about postoperative CRBD

    1 day

Secondary Outcomes (6)

  • The severity of postoperative CRBD

    1 day

  • Postoperative tramadol requirement

    1 day

  • Numeric rating scale (NRS) for postoperative pain.

    1 day

  • Postoperative sufentanil requirement

    1 day

  • Incidences of postoperative side effects

    1 day

  • +1 more secondary outcomes

Study Arms (2)

The PNB group

EXPERIMENTAL

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

The TRAM group

ACTIVE COMPARATOR

Intravenous tramadol of 1.5mg/kg will be administrated after the completion of surgery before extubation.

Drug: Intravenous tramadol

Interventions

Bilateral pudendal nerve blockPROCEDURE

Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation

Also known as: Ropivacaine
The PNB group
Intravenous tramadolDRUG

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

Also known as: Tramadol
The TRAM group

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18years to 75years.
  • American Society of Anesthesiologists (ASA) physical status I, II, or â…¢.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • 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.

    PMID: 27618967DERIVED

MeSH Terms

Interventions

RopivacaineTramadol

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipids

Study Officials

  • Ren Liao, M.D.

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Liao, M.D.

CONTACT

+86-18980602177liaoren7733@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 17, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

CN(1)