Postoperative PainNCT02670759
Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery
A study testing Continuous infusion of bupivacaine and Single dose of bupivacaine in people with Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Continuous infusion of bupivacaine and Single dose of bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Continuous infusion of bupivacaine, Single dose of bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion of bupivacaineDrug
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 bupivacaineDrug
A single dose of bupivacaine will be administered at the end of surgery before skin closure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Single dose of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours following surgery
Secondary outcomes (11)
Opioid intake
Measured: From surgery until 72 hours following surgery
Side-effects attributable to analgesia
The presence of nausea and vomiting will be recorded
Measured: From surgery until 72 hours following surgery
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
Measured: Daily from surgery until 72 hours following surgery
Length of stay in the recovery room
Measured: At discharge from recovery room, approximately 1 hour after end of surgery
Length of stay in the intermediate intensive care unit
Measured: From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day.
Length of stay in the hospital
Measured: From surgery until discharge from the hospital, approximately 2 days
Lung function
Will be measured using a peak flow meter
Measured: Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days
Pulmonary complications
Occurence of atelectasis or pneumonia will be noted
Measured: From surgery until 72 hours following surgery
Time to reach discharge criteria
Will be assessed using the Post Anesthesia Discharge Score (PADS)
Measured: From the day after surgery until discharge from the hospital, approximately 2 days
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
Measured: 48 hours following surgery
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
Measured: 72 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion30 Sep 2017
- Study completion1 Oct 2017
Why it stopped: A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Garneau, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670759
- Sponsor's protocol ID
- 15.291
- Status last verified
- Jun 2019
- First submitted
- 18 Jan 2016
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery (VATS): Analgesic Effectiveness and Role in Fast-track Surgery
- ClinicalTrials.gov ID
- NCT02670759
- Acronym / sponsor ID
- 15.291
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral analgesia | Experimental | Drug: Continuous infusion of bupivacaineA 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. |
| Intercostal analgesia | Active comparator | Drug: Single dose of bupivacaineAn intercostal nerve block using a single dose of bupivacaine will be performed by the surgeon at the end of surgery before skin closure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous infusion of bupivacaineThe 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. | Drug | Paravertebral analgesia |
| Single dose of bupivacaineA single dose of bupivacaine will be administered at the end of surgery before skin closure. | Drug | Intercostal analgesia |
Primary outcome
Intensity of postoperative pain
Time frame: 24 hours following surgery
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
11 secondary outcomes
Opioid intake
Time frame: From surgery until 72 hours following surgery
Side-effects attributable to analgesia
Time frame: From surgery until 72 hours following surgery
Patient's satisfaction with pain relief
Time frame: Daily from surgery until 72 hours following surgery
Length of stay in the recovery room
Time frame: At discharge from recovery room, approximately 1 hour after end of surgery
Length of stay in the intermediate intensive care unit
Time frame: From discharge from the recovery room until discharge from the intermediate intensive care unit, approximately one day.
Length of stay in the hospital
Time frame: From surgery until discharge from the hospital, approximately 2 days
Lung function
Time frame: Immediately prior to surgery and daily from surgery until discharge from the hospital, approximately 2 days
Pulmonary complications
Time frame: From surgery until 72 hours following surgery
Time to reach discharge criteria
Time frame: From the day after surgery until discharge from the hospital, approximately 2 days
Intensity of postoperative pain
Time frame: 48 hours following surgery
Intensity of postoperative pain
Time frame: 72 hours following surgery
Results and safety
The study was stopped early (reason given: A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Garneau, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous infusion of bupivacaine and Single dose of bupivacaine in people with Postoperative Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A 30% decrease in opioid use was obeserved in the paravertebral analgesia group.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of postoperative pain (time frame: 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.