Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

NCT02670759 | Terminated

• 1 other identifier: 15.291
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess:

• The impact of continuous thoracic paravertebral nerve blockade compared to intercostal nerve blockade on the intensity of postoperative pain following VATS in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
• The impact of continuous thoracic paravertebral analgesia on length of stay, opioid intake, respiratory function, incidence of side-effects and postoperative complications. The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade will provide superior postoperative analgesia following VATS when compared to intercostal nerve blockade in patients having a PCA device as their primary analgesic modality. Superior quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake and related side-effects and shorten the hospital stay.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Intensity of postoperative pain

  Will be assessed using a Verbal Numeric Pain Scale (VPNS) from 0 to 10: 0 being no pain at all and 10 being the worst pain imaginable

  24 hours following surgery

Secondary Outcomes (11)

• Opioid intake

  From surgery until 72 hours following surgery

• Side-effects attributable to analgesia

  From surgery until 72 hours following surgery

• Patient's satisfaction with pain relief

  Daily from surgery until 72 hours following surgery

• Length of stay in the recovery room

  At discharge from recovery room, approximately 1 hour after end of surgery

• Length of stay in the intermediate intensive care unit

  From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day.

Study Arms (2)

Paravertebral analgesia

EXPERIMENTAL

A paravertebral nerve block will be performed under ultrasound guidance by the anaesthesiologist prior to the induction of general anesthesia. A catheter will be inserted and a continuous infusion of bupivacaine will be administered.

Drug: Continuous infusion of bupivacaine

Intercostal analgesia

ACTIVE COMPARATOR

An intercostal nerve block using a single dose of bupivacaine will be performed by the surgeon at the end of surgery before skin closure.

Drug: Single dose of bupivacaine

Interventions

Continuous infusion of bupivacaine DRUG

The infusion of local anesthetics will be initiated using a conventional infusion pump and will be transferred on a portable elastomeric pump before discharge from the hospital if the patient is discharged the day after surgery or at the latest on the second morning following surgery. The infusion will continue on the portable pump for 30 hours.

Paravertebral analgesia

Single dose of bupivacaine DRUG

A single dose of bupivacaine will be administered at the end of surgery before skin closure.

Intercostal analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for an elective or emergency VATS surgery (lobectomy or bilobectomy)
• Patients eligible for fast-track surgery
• American Society of Anesthesiologists (ASA) physical status from 1 to 3

You may not qualify if:

• Contraindication to paravertebral nerve blockade
• Severe hepatic insufficiency
• Renal insufficiency
• Known allergy to local anesthetics, morphine or hydromorphone
• Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs (NSAID)
• Inability to understand a verbal numeric pain scale despite previous instruction
• Inability to understand the instructions and precautions related to the use of a portable infusion pump or absence of a resource person or natural caregiver at home
• Preexisting pain at the site where the surgical incision will be made
• Current use of opioids, anticonvulsants or tricyclic antidepressants
• Recent history of drug or opioid abuse

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sebastien Garneau, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: February 2, 2016
• Study Start: March 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: October 1, 2017
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)