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CompletedNCT00542542Updated Apr 13, 2015Results posted

Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

A Phase 3 interventional study of Paravertebral Block and Propofol in Breast Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-13.

Sponsored by M.D. Anderson Cancer Center · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • Reconstructive Surgery
  • Paravertebral Block
  • Anesthesia
  • Propofol
  • Fentanyl
  • Ropivacaine
  • Midazolam
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 89 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    Paravertebral Block + General Anesthesia

    Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)

    Procedure: Paravertebral Block · Drug: Ropivacaine

  • Active comparator
    General Anesthesia Alone

    Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)

    Drug: Propofol · Drug: Fentanyl · Drug: Midazolam

Interventions

  • ProcedureParavertebral Block

    Paravertebral block given as a bolus injection into the paravertebral space.

  • DrugPropofol

    2-2.5 mg/kg IV over 1-4 hours during surgery.

  • DrugFentanyl

    50-250 mcg IV over 1-4 hours during surgery.

  • DrugRopivacaine

    Ropivacaine given by injection into the paravertebral space along the spinal canal.

  • DrugMidazolam

    0.08 mg/kg IV over 1-4 hours during the surgery.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants With No Pain Immediately After 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).

    Time frame: Starting immediately after surgery, every 2 hours till the 6th hour following surgery

07

Results

Posted Apr 13, 2015
Limitations and caveats
The study completed with measurement reporting issues (inconsistencies) leading to uninterpretable data.

Participant flow

Recruitment Period: September 10, 2007 to February 28, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Participant flow — Overall Study
MilestoneGroup 1: Paravertebral Block + General AnesthesiaGroup 2: General Anesthesia Alone
Started4444
Completed4444
Not completed00

Outcome measures

PrimaryProportion of Participants With No Pain Immediately After 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).

Time frame:
Starting immediately after surgery, every 2 hours till the 6th hour following surgery

No measurements were reported for this outcome.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Paravertebral Block + General Anesthesia—0/44 (0%)0/44 (0%)
Group 2: General Anesthesia Alone—0/44 (0%)0/44 (0%)

Baseline characteristics

One participant was removed prior to study randomization.

Age, Continuous
Age, Continuous(years)Group 1: Paravertebral Block + General AnesthesiaGroup 2: General Anesthesia AloneTotal
Median49 (27 to 75)51 (27 to 81)51 (27 to 81)
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Paravertebral Block + General AnesthesiaGroup 2: General Anesthesia AloneTotal
Female444488
Male000
Region of Enrollment
Region of Enrollment(participants)Group 1: Paravertebral Block + General AnesthesiaGroup 2: General Anesthesia AloneTotal
United States444488
08

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00542542
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Oct 11, 2007
Start date
Sep 2007
Primary completion
Mar 2014
Completion
Mar 2014
Results posted
Apr 13, 2015
Last update
Apr 13, 2015

Study contacts

Farzin Goravanchi, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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