Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

NCT02740127 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2014-0990NCI-2016-00860
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs. The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery. This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work. Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

Malignant Neoplasms of Male Genital Organs

Keywords

Malignant neoplasms of male genital organs; Adult Penile Prosthesis Surgery; Caudal nerve block; CNB; General anesthesia; GA; Ropivacaine; Naropin; Epinephrine; Decadron; Dexamethasone; Clonidine; Propofol; Diprivan

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)

  Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.

  24 hours

Secondary Outcomes (2)

• Post-operative Pain the First 24hrs

  24 hours

• Length of Hospital Stay

  32 Hours

Study Arms (2)

Caudal Nerve Block + General Anesthesia Group

EXPERIMENTAL

Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery. Study staff calls participant about 3 days after surgery.

Procedure: Caudal Nerve Block (CNB); Drug: Ropivacaine; Drug: Epinephrine; Drug: Decadron; Drug: Clonidine; Drug: Propofol; Behavioral: Phone Call

General Anesthesia Alone Group

ACTIVE COMPARATOR

Participants receive general anesthesia (GA) during surgery without a caudal nerve block. Study staff calls participant about 3 days after surgery.

Drug: Propofol; Behavioral: Phone Call

Interventions

Caudal Nerve Block (CNB) PROCEDURE

General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.

Caudal Nerve Block + General Anesthesia Group

Ropivacaine DRUG

Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.

Also known as: Naropin

Caudal Nerve Block + General Anesthesia Group

Epinephrine DRUG

Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.

Caudal Nerve Block + General Anesthesia Group

Decadron DRUG

Decadron 10 mg by bolus injection given by anesthesiologist in OR.

Also known as: Dexamethasone

Caudal Nerve Block + General Anesthesia Group

Clonidine DRUG

Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.

Caudal Nerve Block + General Anesthesia Group

Propofol DRUG

General anesthesia given in the OR using Propofol titrated for induction.

Also known as: Diprivan

Caudal Nerve Block + General Anesthesia Group; General Anesthesia Alone Group

Phone Call BEHAVIORAL

Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.

Caudal Nerve Block + General Anesthesia Group; General Anesthesia Alone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that consent to participate.
• Patients undergoing penile prosthesis surgery.
• Patients that are male.
• Patients that are 18 years of age or older.

You may not qualify if:

• Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.
• Patients with a BMI \> 40.
• Patients with chronic pain syndromes.
• Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.
• Prior surgery of the sacrum.
• Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery.
• Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery
• Patients on Celebrex less than 24 hours prior to surgery
• Patients taking more than 81 mg of Aspirin daily

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Ropivacaine; Epinephrine; Calcium Dobesilate; Dexamethasone; Clonidine; Propofol

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Bobby Bellard, Assistant Professor, Anesthesiology & PeriOper Med
• Organization: UT MD Anderson Cancer Center

bbellard@mdanderson.org

(713) 794-1461

Study Officials

• Bobby Bellard, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: June 1, 2016
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: January 24, 2022
• Results First Posted: September 30, 2021

Record last verified: 2022-01

Locations

US (1)