Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00542542
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 2
• Duration (Months): 78
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Primary Objective:

To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia.

Secondary Objectives:

1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.

2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.

3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Paravertebral Block; Drug: Propofol; Drug: Fentanyl; Drug: Ropivacaine; Drug: Midazolam	Phase 3

Detailed Description

Paravertebral Blocks and General Anesthesia The use of a paravertebral block involves injecting local anesthesia (a numbing medicine) into the patient's back to numb specific areas (the breast[s] for this study) for surgery.

General anesthesia is medicine that is used to put patients to sleep so that there is no feeling of pain.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. You will have an equal (50/50) chance of being assigned to either group.

Participants in one group will receive a paravertebral block (the local anesthetic ropivacaine) plus general anesthesia.

Participants in the other group will receive general anesthesia (propofol, desflurane, and fentanyl) without a paravertebral block.

Drug Administration:

If you are assigned to receive the paravertebral block plus general anesthesia, you will have a paravertebral block placed just before surgery begins. Ropivacaine will be given by injection into the paravertebral space along the spinal canal.

If you are assigned to receive general anesthesia without a paravertebral block, you will be given propofol, desflurane, and fentanyl by vein over 1-4 hours during surgery.

Participants in both groups will receive promethazine, famotidine, and dexamethasone at the start of surgery to help decrease or eliminate nausea and vomiting that may occur after surgery.

Follow-up:

After your surgery is complete, before you leave the hospital, you will have the following evaluations:

• You will be asked how you are feeling so that the study doctor can determine how much medication you may need for pain and nausea as well as how long your hospital stay may need to be. You may be given fentanyl and dilaudid for pain and ondansetron and promethazine for nausea.

• You will also be asked about your satisfaction with the anesthesia. You will be asked these questions within the first hour, between 1 and 3 hours, and between 3 and 6 hours after surgery. Once you are discharged from the hospital, study staff will contact you by phone or talk with you when you return for a visit (at 18 -22 hours and 1 week after surgery) to ask these questions. It will take about 3-5 minutes to ask these questions each time.

Length of Study:

Your participation in this study will be over after the 1 week follow-up telephone call.

This is an investigational study. Paravertebral blocks and general anesthesia are FDA approved and commercially available. Up to 89 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paravertebral Block + General Anesthesia Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)	Procedure: Paravertebral Block; Paravertebral block given as a bolus injection into the paravertebral space.; Drug: Ropivacaine; Ropivacaine given by injection into the paravertebral space along the spinal canal.
Active Comparator: General Anesthesia Alone Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)	Drug: Propofol; 2-2.5 mg/kg IV over 1-4 hours during surgery.; Drug: Fentanyl; 50-250 mcg IV over 1-4 hours during surgery.; Drug: Midazolam; 0.08 mg/kg IV over 1-4 hours during the surgery.

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants With No Pain Immediately After Surgery [Starting immediately after surgery, every 2 hours till the 6th hour following surgery]

   Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients that consent to participate

2. Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone

3. Patients that are female

4. Patients that are over the age of 18

5. Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.

Exclusion Criteria:

1. Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)

2. Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's

3. Patients with BMI<20 or >40

4. Patients that are pregnant

5. Patients with chronic pain syndromes.

6. Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Farzin Goravanchi, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00542542
• Other Study ID Numbers: 2006-0961; NCI-2012-01557
• First Posted: Oct 11, 2007
• Last Update Posted: Apr 13, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by M.D. Anderson Cancer Center: Breast Cancer; Reconstructive Surgery; Paravertebral Block; Anesthesia; Propofol; Fentanyl; Ropivacaine; Midazolam
• Additional relevant MeSH terms: Breast Neoplasms; Fentanyl; Midazolam; Propofol; Ropivacaine

Study Results

Participant Flow

Recruitment Details	Recruitment Period: September 10, 2007 to February 28, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Detail	Of the 89 participants enrolled, one participant was excluded prior to group assignment.

Arm/Group Title	Group 1: Paravertebral Block + General Anesthesia	Group 2: General Anesthesia Alone
Arm/Group Description	Paravertebral Block + General Anesthesia (Ropivacaine) Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space. Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.	General Anesthesia Alone (Propofol, Midazolam, Fentanyl) Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery. Fentanyl: 50-250 mcg IV over 1-4 hours during surgery. Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.
Period Title: Overall Study
STARTED	44	44
COMPLETED	44	44
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1: Paravertebral Block + General Anesthesia	Group 2: General Anesthesia Alone	Total
Arm/Group Description	Paravertebral Block + General Anesthesia (Ropivacaine) Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space. Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.	General Anesthesia Alone (Propofol, Midazolam, Fentanyl) Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery. Fentanyl: 50-250 mcg IV over 1-4 hours during surgery. Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.	Total of all reporting groups
Overall Participants	44	44	88
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	49	51	51
Sex: Female, Male (Count of Participants)
Female	44 100%	44 100%	88 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	44 100%	44 100%	88 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With No Pain Immediately After Surgery
Description	Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).
Time Frame	Starting immediately after surgery, every 2 hours till the 6th hour following surgery

Outcome Measure Data

Analysis Population Description

Analysis was not possible from data collected due to reporting inconsistencies.

Arm/Group Title	Group 1: Paravertebral Block + General Anesthesia	Group 2: General Anesthesia Alone
Arm/Group Description	Paravertebral Block + General Anesthesia (Ropivacaine) Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space. Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.	General Anesthesia Alone (Propofol, Midazolam, Fentanyl) Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery. Fentanyl: 50-250 mcg IV over 1-4 hours during surgery. Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse Event Reporting was from baseline to end of study involvement, approximately 21 days. Overall active study period from December 03, 2007 to March 05 2011.
Arm/Group Title	Group 1: Paravertebral Block + General Anesthesia		Group 2: General Anesthesia Alone
Arm/Group Description	Paravertebral Block + General Anesthesia (Ropivacaine) Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space. Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.		General Anesthesia Alone (Propofol, Midazolam, Fentanyl) Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery. Fentanyl: 50-250 mcg IV over 1-4 hours during surgery. Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.
All Cause Mortality
	Group 1: Paravertebral Block + General Anesthesia		Group 2: General Anesthesia Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: Paravertebral Block + General Anesthesia		Group 2: General Anesthesia Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Paravertebral Block + General Anesthesia		Group 2: General Anesthesia Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)

Limitations/Caveats

The study completed with measurement reporting issues (inconsistencies) leading to uninterpretable data.

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.