Health TrialsbyHealthPanel

Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

ConditionPain, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorWomen's College Hospital

About this trial

Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III patients

Ages 18-70 years

Penile Inversion Vaginoplasty

Disqualifiers

Local infection

History of use of over 30mg oxycodone or equivalent per day.

Contraindication to a component of multi-modal analgesia

Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saddle block

    Procedure/Surgery

    The injected solution will be comprised of 5mg of heavy Bupivacaine 0.75% plus 100mcg of Morphine will be injected into the intrathecal space.

  • pudendal nerve block

    Procedure/Surgery

    As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with a mixture of Local Anesthetic as follows: 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Saddle block with intrathecal morphine GroupExperimental treatment 2 interventions
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative opioid (analgesic) consumption

Consumption intra-operatively, total in-hospital postoperative consumption measured oral morphine equivalents (MEQ)

Time frame
48 hours

Secondary outcomes

1

Time to first analgesic request

At recovery room discharge and hospital discharge

Time frame
24 hours
2

Pain Assessment (VAS)

Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain

Time frame
Up to 48 hours post-operatively
3

Incidence of opioid-related side effects

Itching, respiratory depression, hypotension, nausea and vomiting

Time frame
Up to 48 hours post-operatively
4

Presence of Block-related complications

Persistent paresthesia, post dural puncture headache

Time frame
Up to 48 hours post-operatively

Other outcomes

Sponsors and contacts

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Women's College Hospital

Lead sponsor

Source ClinicalTrials.gov
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