TAP: Postoperative Pain Control for Prostatectomy

• Sponsor: Nova Scotia Health Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT00913068
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The researchers propose to investigate a relatively new anesthetic procedure, in order to maximize patient comfort and minimize the use of narcotics after a radical prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Transverse Abdominal Plan (TAP); Procedure: standard post op pain control	N/A

Detailed Description

Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). As the amount of opiates used can be significant, we have to be aware of their inherent risks. Opiates have an excellent pain control profile, working peripherally by decreasing the amount of neurotransmitters released from neurons involving noxious stimuli, and also in their central processing. Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.

Thus we propose the use of a relatively new regional anesthetic technique be employed to further decrease the need for opiates in our prostatectomy patients' post-op course, while adequately controlling their pain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Post Operative Analgesia Using the Transverse Abdominal Plan (TAP) Block in Patients Undergoing a Radical Retropubic Prostatectomy (RRP)
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAP arm in the experimental arm, the procedure will consist of the staff urologist injecting local anesthetic into the anterior abdominal wall bilaterally from the inside of the abdomen at the end of their surgery	Procedure: Transverse Abdominal Plan (TAP); An injectable anesthetic is introduced to a specific anatomic area where the sensory neurons supplying the operative field.; Other Names: lidocaine ropivacaine
Active Comparator: standard post operative pain control Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.	Procedure: standard post op pain control; opiates; Other Names: timed assessments for pain and medications

Outcome Measures

Primary Outcome Measures

1. Total Milligrams of Opiates [2, 6,12, 24, 48 and 72 hours]

   mean number of milligrams used postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• prostate cancer for radical prostatectomy

Exclusion Criteria:

• chronic pain or opiate use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2Y9

Sponsors and Collaborators

• Nova Scotia Health Authority

Investigators

• Principal Investigator: Ricardo A Rendon, MD, Queen Elizabeth Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ricardo Rendon, Dr, Nova Scotia Health Authority
• ClinicalTrials.gov Identifier: NCT00913068
• Other Study ID Numbers: version 2 July 13, 2009
• First Posted: Jun 3, 2009
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Ricardo Rendon, Dr, Nova Scotia Health Authority: radical prostatectomy
• Additional relevant MeSH terms: Prostatic Neoplasms; Lidocaine; Ropivacaine

Study Results

Participant Flow

Recruitment Details	<75, open radical prostatectomy, December 2010 - September 2011. Ketorolac, paralytics, fentanyl, propofol, sevoflurane or isofluroane use was at discretion of anesthetist. Patients requiring spinal or epidural anesthetics, history of chronic pain, chronic opiate use and and need for second general anesthetic within the first 24 h were excluded.
Pre-assignment Detail	16 were excluded before starting the study due to chronic opiate use, or for requiring a secondary general anesthetic

Arm/Group Title	TAP Arm	Standard Post Operative Pain Control
Arm/Group Description	in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm	Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
Period Title: Overall Study
STARTED	56	54
COMPLETED	48	46
NOT COMPLETED	8	8

Baseline Characteristics

Arm/Group Title	TAP Arm	Standard Post Operative Pain Control	Total
Arm/Group Description	in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm	Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.	Total of all reporting groups
Overall Participants	56	54	110
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (6.5)	60.6 (6.5)	60.6 (6.5)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	56 100%	54 100%	110 100%
Region of Enrollment (participants) [Number]
Canada	56 100%	54 100%	110 100%

Outcome Measures

1. Primary Outcome

Title	Total Milligrams of Opiates
Description	mean number of milligrams used postoperatively
Time Frame	2, 6,12, 24, 48 and 72 hours

Outcome Measure Data

Analysis Population Description

In order to achieve a power of 0.9 with a 20% change in pain scores, 40 patients were needed per arm

Arm/Group Title	TAP Arm	Standard Post Operative Pain Control
Arm/Group Description	in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm	Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
Measure Participants	48	46
Mean (Standard Deviation) [mg]	5.15 (4.49)	2.52 (2.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAP Arm
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	TAP Arm		Standard Post Operative Pain Control
Arm/Group Description	in the experimental arm, the procedure will consist of the staff urologist injecting percutaneously 20 mg of ropivacaine bilaterally into the anterior abdominal wall . Postoperative pain management same as per standard arm		Injection of saline. Our current post operative analgesic strategy involves a multi-modal approach, using local injectable anesthetic around the incision and systemic medications (i.e. non-steroidal anti-inflammatories, acetaminophen and break-through doses of opiates). Some of the more common adverse reactions are reparatory depression, sedation, confusion, delirium, nausea, pruritis, constipation, hypotension and bradycardia. Often it is these resulting side effects that extend the length of in hospital rehabilitation, and decrease a patient's overall satisfaction.
All Cause Mortality
	TAP Arm		Standard Post Operative Pain Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TAP Arm		Standard Post Operative Pain Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/54 (0%)
Other (Not Including Serious) Adverse Events
	TAP Arm		Standard Post Operative Pain Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/54 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.