Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01700491

Acronym

ParaEpi

Enrollment

Registered

2012-10-04

Start date

2012-10-31

Completion date

2013-11-30

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Paravertebral Catheter, Epidural Catheter, Analgesia, Hypotension, Analgesia,Epidural, Analgesia,Paravertebral

Brief summary

Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.

Detailed description

There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.

Interventions

DRUGEpidural Catheter 0.2% ropivacaine

0.2% ropivacaine into epidural space and saline into paravertebral space

DRUGParavertebral Catheter 0.4% ropivacaine

0.4% ropivacaine into paravertebral space and saline into the epidural space

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Open thoracotomy * Age \> 18 yo * Able to use a patient controlled analgesia device

Exclusion criteria

* Previous thoracotomy * Previous spine surgery * Chronic pain condition * Ongoing narcotic use * Prior narcotic abuse * Active chest infection * Chest trauma * Anticoagulation * Other contraindication to epidural catheter placement * Allergy to local anesthetic or narcotic

Design outcomes

Primary

Measure	Time frame	Description
Analgesic Effect	At postoperative day 5	Total cumulative dose of morphine equivalent narcotics.

Secondary

Measure	Time frame	Description
Hypotension	At postoperative day 5	Cumulative time in which the systolic blood pressure is below 90mmHg.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026