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Comparison of Bilateral Thoracic Paravertebral Block to Thoracic Epidural Analgesia for Post Operative Analgesia in Patients Undergoing Abdominal Surgery

NCT01735851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-09-01

No results posted yet for this study

Summary

Pain following abdominal surgery is managed with the use of thoracic epidural analgesia (TEA) where the epidural is inserted in the spine at the level of scapula The risks due to TEA include difficulty with insertion, failure in up to 40% of patient in the perioperative period, fall in blood pressure and a rare devastating complication of paralysis either due to bleeding or infection. Injury to spinal cord is also a feared complication. Therefore alternative techniques need to be evaluated. Paravertebral block (PVB) has been documented to provide pain relief following abdominal surgery using an earlier technique which posed the risk of puncture of the covering to the lung (pleura) resulting in pneumothorax. The current technique involves the use of curled catheters inserted using ultrasonography to lie outside the pleura where the nerves travel thus reducing the chances of pneumothorax and catheter migration. Objective of the current study is to compare the efficacy and safety of bilateral PVB with TEA. Patients undergoing bowel surgery will be randomized to receive thoracic epidural analgesia or bilateral thoracic paravertebral blocks. Pain scores during rest and coughing, failure and complication rates will be compared between the two groups.

Objective:

The objective of the investigators is to determine whether ultrasound (US)-guided bilateral thoracic paravertebral blocks (PVB) using curled catheter provides effective post-operative analgesia as compared to thoracic epidural analgesia in patients undergoing open abdominal bowel surgeries.

The primary outcome of this study will be the pain scores over the first 24 hours following open bowel surgeries.

Secondary outcomes include

1. Analgesic consumption in the perioperative period,
2. Block related data (block performance time, success rate, extent of sensory block, complications)
3. Hemodynamic parameter every 6 hourly
4. Incidence of side effects like nausea and pruritus scores, time to return of bowel activity

Hypothesis

Null Hypothesis: Primary.

Paravertebral blocks provide equal analgesia in the early postoperative period (first 24 hours of surgery) as compared to thoracic epidural analgesia in patients undergoing bowel surgeries by laparotomy.

Secondary

1. The analgesic consumption between PVB and TEA is not different during the first 24 hours following surgery
2. The block performance time, success rate and extent of sensory block with PVB are not different from that of TEA.
3. Side effects and complications following bilateral PVB are not different from those occurring after TEA

Conditions

  • Postoperative Pain

Interventions

DRUG

Thoracic epidural analgesia

PROCEDURE

Bilateral Paravertebral block

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01735851 on ClinicalTrials.gov