Effects of Perioperative B&O Suppositories on Post-op Pain and Morphine Use After Laparoscopic Prostatectomy

Benaroya Research Institute

Status: Completed

Conditions: Pain

Treatments: Drug: belladonna 16.2 mg and opium 60 mg suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT00863928

IRB08100 (Other Identifier)

Details and patient eligibility

About

This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your surgeon will know which group you are in.

Full description

All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Post-operative pain was assessed by a visual analog scale (VAS) and post-operative narcotic use was calculated in intravenous morphine equivalents.

Enrollment: 135 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for laparoscopic radical prostatectomy at Virginia Mason, who do not have chronic pain or allergies to opioid analgesics are eligible for this study.

Exclusion criteria

• Women are excluded due to the absence of a prostate.

• Children are excluded due to the absence of prostate cancer in this group.

• Patients meeting any of the following will not be eligible for the study:

  • Patients at risk for complications from anticholinergic agents including those with a history of glaucoma, bronchial asthma, convulsive disorder, or high risk for delirium
  • History of previous allergies or adverse reactions to belladonna and opium and/or opioid analgesics
  • History of chronic pain or chronic use of opioid and nonopioid analgesics
  • History of alcohol or opioid dependency/abuse within last three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups

Control Arm

No Intervention group

Description:

No suppository given

B & O suppository

Experimental group

Description:

B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)

Treatment:

Drug: belladonna 16.2 mg and opium 60 mg suppository