Clinical trial NCT02670759: Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
Official title: Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Appropriate postoperative analgesia is crucial in fast-track surgery, which is a multimodal therapeutic strategy that aims toward enhanced postoperative recovery and shortened hospital stay. Although VATS is considered a minimally invasive procedure, patients have reported moderate to severe pain of variable duration following surgery. The ideal postoperative analgesia regimen for VATS has not been elucidated. Systemic opioids given through patient-controlled devices (PCA) are routinely used after these procedures but their analgesic effect can be limited and undesirable side-effects may occur. Intercostal nerve blockade is also widely used to alleviate pain following VATS and can be used as an adjunct to systemic opioids. Paravertebral nerve blockade is an interesting alternative for analgesia following VATS. The duration of pain relief associated with paravertebral nerve blockade may vary from 4 to 48 hours. However, the duration of the analgesic effect can be prolonged using a continuous infusion of local anesthetics.

This study will compare the efficacy of continuous ambulatory paravertebral analgesia to intercostal analgesia. All patients will have a PCA device as their primary analgesic modality.

Methods:

Seventy patients will be randomized to receive either continuous paravertebral analgesia or intercostal analgesia. Anesthetic technique and monitoring will be standardized.

On arrival in the recovery room, each patient will have a PCA device installed. PCA doses will be standardized. All patients will also receive acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDS) as co-analgesia. PCA will be removed 24 hours after surgery and oral opioids will then be administered as needed.

From their arrival in the recovery room, patients in the paravertebral analgesia group will be administered a bupivacaine 0.0625% infusion through a conventional infusion pump at a rate of 10 mL/h. Before discharge from the hospital on the day following surgery or at the latest on the morning of the second day, the bupivacaine infusion will be transferred to a portable elastomeric pump. The infusion will continue for the next 30 hours at a rate of 10 mL/h.

During the first 72 hours following surgery, the following information will be recorded: intensity of pain, opioid intake, side-effects attributable to analgesia and patient's level of satisfaction towards pain management. The occurence of pulmonary complications will be noted. Lung function will be measured using a peak flow meter. Length of stay in the recovery room, in the intermediate intensive care unit and in the hospital will be recorded. Time to reach post-anesthesia discharge criteria will be recorded.

Patients will be contacted by telephone 2 times a day if hospital discharge occurs before 72 hours after surgery to assess their level of pain and analgesic intake, the presence of side-effects or complications and their satisfaction level towards pain management.

This trial will also include a sub-study to be performed on ten human cadavers. The goal of the sub-study will be to assess the impact of the orientation of the bevel of the paravertebral block needle on the ease of insertion and positioning of the paravertebral catheter using ultrasound imaging.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intensity of postoperative pain
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: Opioid intake
timeFrame: From surgery until 72 hours following surgery
measure: Side-effects attributable to analgesia
timeFrame: From surgery until 72 hours following surgery
measure: Patient's satisfaction with pain relief
timeFrame: Daily from surgery until 72 hours following surgery
measure: Length of stay in the recovery room
timeFrame: At discharge from recovery room, approximately 1 hour after end of surgery
measure: Length of stay in the intermediate intensive care unit
timeFrame: From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day.
measure: Length of stay in the hospital
timeFrame: From surgery until discharge from the hospital, approximately 2 days
measure: Lung function
timeFrame: Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days
measure: Pulmonary complications
timeFrame: From surgery until 72 hours following surgery
measure: Time to reach discharge criteria
timeFrame: From the day after surgery until discharge from the hospital, approximately 2 days
measure: Intensity of postoperative pain
timeFrame: 48 hours following surgery
measure: Intensity of postoperative pain
timeFrame: 72 hours following surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Sebastien Garneau, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: