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

NCT01735851 | Completed Phase 4

• 1 other identifier: HSREB UWO 103035
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 1.Analgesic consumption in the perioperative period,
2. 2.Block related data (block performance time, success rate, extent of sensory block, complications)
3. 3.Hemodynamic parameter every 6 hourly
4. 4.Incidence of side effects like nausea and pruritus scores, time to return of bowel activity
5. 5.The analgesic consumption between PVB and TEA is not different during the first 24 hours following surgery
6. 6.The block performance time, success rate and extent of sensory block with PVB are not different from that of TEA.
7. 7.Side effects and complications following bilateral PVB are not different from those occurring after TEA

Conditions

Postoperative Pain

Keywords

Thoracic epidural analgesia; Paravertebral block; pain; postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores at rest and on coughing in the first 24 postoperative hours

  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.

  From arrival in PACU until 24 hours of arrival in the PACU

Secondary Outcomes (1)

• total pain scores till 72 hours postoperatively

  from arrival in PACU to 3rd postoperative day (72 hours)

Study Arms (2)

Thoracic epidural analgesia

ACTIVE COMPARATOR

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

Bilateral Paravertebral block

EXPERIMENTAL

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

Interventions

Thoracic epidural analgesia DRUG

Also known as: Thoracic Epidural Anesthesia

Thoracic epidural analgesia

Bilateral Paravertebral block PROCEDURE

Bilateral Paravertebral block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with associated significant cardiac and respiratory disease
• Patients with coexisting hematological disorder or with deranged coagulation parameters.
• Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
• Patients with anatomical deformity of spine
• Psychiatric illnesses
• Emergency surgery
• Lack of informed consent.
• Allergy to any of the drugs used in the study
• Contraindications to epidural analgesia -

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (3)

• Finucane BT, Ganapathy S, Carli F, Pridham JN, Ong BY, Shukla RC, Kristoffersson AH, Huizar KM, Nevin K, Ahlen KG; Canadian Ropivacaine Research Group. Prolonged epidural infusions of ropivacaine (2 mg/mL) after colonic surgery: the impact of adding fentanyl. Anesth Analg. 2001 May;92(5):1276-85. doi: 10.1097/00000539-200105000-00038.

  PMID: 11323362 BACKGROUND

• Luyet C, Meyer C, Herrmann G, Hatch GM, Ross S, Eichenberger U. Placement of coiled catheters into the paravertebral space. Anaesthesia. 2012 Mar;67(3):250-5. doi: 10.1111/j.1365-2044.2011.06988.x.

  PMID: 22321080 BACKGROUND

• Sondekoppam RV, Uppal V, Brookes J, Ganapathy S. Bilateral Thoracic Paravertebral Blocks Compared to Thoracic Epidural Analgesia After Midline Laparotomy: A Pragmatic Noninferiority Clinical Trial. Anesth Analg. 2019 Sep;129(3):855-863. doi: 10.1213/ANE.0000000000004219.

  PMID: 31425230 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 28, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CA (1)