Health TrialsbyHealthPanel

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

ConditionUrethral Stricture, Male
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco

About this trial

Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial.

Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men, age 18 or older

Undergoing anterior urethroplasty with buccal grafting

Able to consent

Disqualifiers

Taking chronic opiates for pain

Diagnosis of chronic pain

Prior buccal urethroplasty

Vulnerable population (e.g. prisoner)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Buccal Harvest

    Drug

    Our institutions current anesthetic regimen. Comparison group

  • Basic buccal procedure + Long acting local

    Drug

    Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.

  • Basic buccal procedure + Buccal block

    Drug

    Addition of long-acting local anesthetic as a buccal block after oral graft harvest

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Group 1: Standard of careActive comparator 1 intervention
Group B: Group 2: Standard of care + Long acting localExperimental treatment 1 intervention
Group C: Group 3: Standard of care + Buccal blockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change(s) in Post-operative pain

The Wong-Baker FACES pain scale is a validated scale where a score of 0 is no pain and 10 is the worst pain imaginable. Pain greater than or equal to 5 would result in significant limitations on daily life. Oral, incisional (surgical site), and overall pain will each be assigned a score of 0-10 at each time point (9 total scores).

Time frame
Postoperative Day 1, 5, 10

Secondary outcomes

1

Change(s) in Post-operative Narcotic use

Patient measure of number of oxycodone tablets taken (0-5). Patient request for additional narcotic medicaiton (Yes/No) Patient measure of adherence to non-narcotic pain regiman (Yes/No)

Time frame
Postoperative Day 1, 5, 10

Other outcomes

1

Peri-operative Complications

Clavien-Dingo is a validated tool to measure the severity of post-operative outcomes. Class I are mild and require no treatment. Class V is death.

Time frame
Postoperative Day 0-30

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

MedStar Georgetown University Hospital

Collaborator

Source ClinicalTrials.gov
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