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OpenTrials
Completed

NCT Number: NCT02363777

Paravertebral Catheters for Pancreatic Surgery

Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.

Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.

Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain.

Secondary Objectives:

1. To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery. 2. To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.

Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.

Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased total maximal pain scores compared to patients treated with thoracic epidural for post-operative pain.

Secondary Objectives:

  • To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
  • To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
  • Synopsis and Medical Application:

Specific Aims:

Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to thoracic epidural for post-operative pain from open pancreatic surgery.

Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the thoracic epidural group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • All patients undergoing open pancreatic surgery.

Exclusion criteria

  • • Previous difficult airway or multiple previous intubations
  • History of myasthenic syndrome
  • Systemic infection
  • Pre-existing sensory deficit
  • PT >14 or PTT >40 sec
  • Platelet count less than 50,000
  • Creatinine > 1.5
  • Allergy to local anesthetics
  • Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
  • Use of a spinal or epidural anesthetic for surgery
  • Daily use of opioid for more than a week or chronic pain syndrome
  • Lack of patient cooperation
  • Contraindication to regional anesthesia
  • Infection at injection site
  • Inability to guarantee sterile equipment or sterile conditions for the block
  • Patient refusal
  • Risk of local anesthetic toxicity
  • Coagulopathy or bleeding disorder
  • Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
  • Ipsilateral diaphragmatic paresis;

Treatment and study plan

Epidural

Procedure

A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively

Paravertebral catheters

Procedure

Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively

Primary outcomes

  1. total Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 1 through postoperative day 5

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

Secondary outcomes

  1. Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 1

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

  2. Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 2

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

  3. Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 3

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

  4. Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 4

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

  5. Maximal Pain scored via NRS 0-10 scale

    Time frame: on postoperative day 5

    maximal pain scored via NRS 0-10 scale assessed by independent assessor

  6. Nausea/vomiting

    Time frame: the first five days postoperatively

    the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor

  7. Length of stay

    Time frame: when the patient meets discharge criteria or is discharged home, expected length of stay 10 days

    up through the time the patient is discharged , expected length of stay 10 days.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 16, 2015
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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