Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

Postoperative Pain Clinical Trial

Official title:

Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02670759
• Other study ID #: 15.291
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: June 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 1, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Continuous infusion of bupivacaine
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.
• Single dose of bupivacaine
A single dose of bupivacaine will be administered at the end of surgery before skin closure.

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid intake		From surgery until 72 hours following surgery
Secondary	Side-effects attributable to analgesia	The presence of nausea and vomiting will be recorded	From surgery until 72 hours following surgery
Secondary	Patient's satisfaction with pain relief	Will be assessed using a scale from 1 to 4: 1 being completely dissatisfied and 4 being completely satisfied	Daily from surgery until 72 hours following surgery
Secondary	Length of stay in the recovery room		At discharge from recovery room, approximately 1 hour after end of surgery
Secondary	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.
Secondary	Length of stay in the hospital		From surgery until discharge from the hospital, approximately 2 days
Secondary	Lung function	Will be measured using a peak flow meter	Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days
Secondary	Pulmonary complications	Occurence of atelectasis or pneumonia will be noted	From surgery until 72 hours following surgery
Secondary	Time to reach discharge criteria	Will be assessed using the Post Anesthesia Discharge Score (PADS)	From the day after surgery until discharge from the hospital, approximately 2 days
Secondary	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	48 hours following surgery
Secondary	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	72 hours following surgery