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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Sugantha Ganapathy, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01735851
First received: October 26, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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

Condition Intervention Phase
Postoperative Pain
Drug: Thoracic epidural analgesia
Procedure: Bilateral Paravertebral block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Bilateral Thoracic Paravertebral Block to Thoracic Epidural Analgesia for Post Operative Analgesia in Patients Undergoing Abdominal Surgery - A Randomized Open Label Study

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Postoperative pain scores at rest and on coughing in the first 24 postoperative hours [ Time Frame: From arrival in PACU until 24 hours of arrival in the PACU ] [ Designated as safety issue: No ]
    Pain scores at rest and coughing will be documented every 15 minutes for the first 2 hours in PACU and thereafter every 6 hourly until the first 24 hours. Patients may receive intravenous dilaudid boluses in the PACU if the pain scores are greater than 5. patients will be receiving IVPCA or PCEA depending on the group allocation in the PACU. The total dose of narcotic used will be documented.


Secondary Outcome Measures:
  • total pain scores till 72 hours postoperatively [ Time Frame: from arrival in PACU to 3rd postoperative day (72 hours) ] [ Designated as safety issue: No ]
    Pain scores at rest and coughing will be documented every 15 minutes for the first 2 hours in PACU and thereafter every 6 hourly until the block catheters are removed at 72 hours. Patients may receive intravenous dilaudid boluses if the pain scores are greater than 5. The total dose of narcotic used will be documented.


Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thoracic epidural analgesia
Group 1 will receive a catheter congruent TEA. The epidural space will be identified using the loss of resistance technique. After a test dose to rule out intravascular and intrathecal placement of the catheterthe initial block will be made with 0.25% bupivacaine 5 mL followed by 3 mL aliquots administered every 5 minutes to establish a block between T8 and T12. An infusion will be started at 8 mL/hour with 0.1 % bupivacaine with 10microgram/mL of dilaudid and continued for 72 hours. Additional nurse administered boluses of 5-10mL of the standard solution will be allowed via the epidural catheter every 6hourly for poor pain control followed by an increase in the basal infusion rate up to a maximum of 14mL/hr. Patients will be allowed to self administer additional boluses of 3mL of the standard infusate every 20minutes (PCEA)
Drug: Thoracic epidural analgesia
Other Name: Thoracic Epidural Anesthesia
Experimental: Bilateral Paravertebral block
Group 2 will have bilateral PVB catheters inserted using the ultrasound with patients prone. A high-frequency linear probe will used to visualize the transverse process, pleura and the internal intercostal membrane. A 17 guage Tuohy needle will be inserted to puncture the internal intercostal membrane. Injection of local anesthetic will push the pleura away, which will be the end point of needle position. A curved pigtail catheter will be inserted and further 5mL of local anesthetic will be injected while observing further movement of pleura. A similar procedure will be done on the contralateral side at the same level. Infusion of 0.2% ropivacaine will be continued for the next 72 hours. They will also receive IVPCA and additional nurse administered boluses of 5-10mL of ropivacaine 0.2% in the PVB every 6 hourly to the side of maximal pain.
Procedure: Bilateral Paravertebral block

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and females of 18-85years of age, scheduled to undergo open abdominal surgeries.
  2. ASA Class I, II, III -

Exclusion Criteria:

  1. Patients with associated significant cardiac and respiratory disease
  2. Patients with coexisting hematological disorder or with deranged coagulation parameters.
  3. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  4. Patients with anatomical deformity of spine
  5. Psychiatric illnesses
  6. Emergency surgery
  7. Lack of informed consent.
  8. Allergy to any of the drugs used in the study
  9. Contraindications to epidural analgesia -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735851

Contacts
Contact: Sugantha Ganapathy, FRCPC 519 685 8500 ext 35115 sganapat@uwo.ca
Contact: Rakesh Vijayash Sondekoppam, MD 519 685 8500 Rakesh.SondekoppamVijayashankar@londonhospitals.ca

Locations
Canada, Ontario
London Health Sciences Centre University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Sugantha Ganapathy, FRCPC    519 685 8500 ext 35115    sganapat@uwo.ca   
Contact: Rakesh Sondekoppam, MD    519 685 8500    Rakesh.SondekoppamVijayashankar@londonhospitals.ca   
Sub-Investigator: Ranjita Sharma, MD         
Sub-Investigator: Jonathan Brookes, MD         
Sub-Investigator: Shalini Dhir, FRCPC         
Sub-Investigator: Indu Singh, FRCPC         
Sub-Investigator: Brian Taylor, FRCSC         
Sub-Investigator: Hernandez Roberto, FRCSC         
Sub-Investigator: Ward Davies, FRCSC         
Sub-Investigator: Patrick Colquhoun, FRCSC         
Sub-Investigator: Vivian McAllister, FRCSC         
Sub-Investigator: William Wall, FRCSC         
Sub-Investigator: Douglas Quan, FRCSC         
Sub-Investigator: Magdalena Terlecki, MD         
Sub-Investigator: Rakesh Vijayashankar, MD         
Principal Investigator: Sugantha Ganapathy, FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
  More Information

Publications:
Responsible Party: Sugantha Ganapathy, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01735851     History of Changes
Other Study ID Numbers: HSREB UWO 103035
Study First Received: October 26, 2012
Last Updated: June 19, 2013
Health Authority: Canada: HSREB UWO, London, Ontario

Keywords provided by Lawson Health Research Institute:
Thoracic epidural analgesia
Paravertebral block
pain
postoperative

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014