Postoperative PainNCT01715701
Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy
A study testing Paravertebral nerve blockade and Intercostal nerve blockade 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 preoperative multilevel thoracic paravertebral nerve blockade compared to intercostal nerve blockade performed at the end of surgery on the intensity of postoperative pain 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?
- Paravertebral nerve blockade and Intercostal nerve blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2014
- 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 thoracoscopic surgery
- Physical status 1-4
Who cannot join
- Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local infection at the site of injection, spinal deformity)
- Severe renal or hepatic insufficiency
- A known allergy to local anesthetics, morphine or hydromorphone
- The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction
- Preexisting pain at the site of the surgical incision
- Current use of opioids, anticonvulsants or tricyclic antidepressants
- A recent history of drug or opioid abuse
- Patient refusal
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: Efficacy of Multilevel Thoracic Paravertebral Nerve Blockade to Reduce Postoperative Pain Following Video-assisted Thoracic Surgery
This study is designed to assess:
- The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to intercostal nerve blockade performed at the end of surgery on the intensity of postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
- The incidence of chronic pain at 6 months following video-assisted thoracic surgery.
- The impact of preoperative multilevel paravertebral nerve blockade on patients' quality of life at 6 months following surgery compared to intercostal nerve blockade and to a control group using PCA alone.
Read more
Hypothesis:
- The basic hypothesis of this study is that preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will provide superior postoperative analgesia and lower opioid consumption compared to PCA alone during the first 24 hours following surgery.
- Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence of chronic pain at 6 months following surgery.
- Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will shorten the length of stay in the intermediate intensive care unit and shorten the hospital stay.
- Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will reduce postoperative pulmonary complications.
Read the detailed description
Video-assisted thoracoscopy is increasing in popularity. Although it is considered a less invasive treatment than thoracotomy, patients have reported moderate to severe pain of variable duration. Benefits of adequate analgesia no longer need to be demonstrated. Optimal analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances patient's satisfaction and quality of life following surgery. Furthermore, adequate postoperative analgesia may reduce the occurrence of chronic pain. The incidence of chronic pain following thoracoscopic procedures ranges from 20-47%.
The ideal postoperative analgesia regimen for the pain related to thoracoscopy has not been elucidated.
Systemic opioids given through patient-controlled devices (PCA) may be used after thoracoscopic procedures but the analgesic effect can be limited and undesirable side-effects may occur.
Thoracic epidural has emerged as the preferred pain control technique following thoracotomy. However, the role of epidural analgesia after thoracoscopy remains debatable. Side-effects may outweigh the benefits of the technique in the context of minimally invasive surgeries.
Paravertebral blockade is an alternative to epidural analgesia. The duration of pain relief associated with this technique may vary from 4 to 48 hours. Its effectiveness has been shown to be equal or superior to that of epidural analgesia for post-thoracotomy pain. Its popularity for pain management following thoracotomy has promoted its use after thoracoscopic procedures. Preoperative paravertebral blockade could also result in a reduction of chronic pain following surgery.
Intercostal nerve blockade is widely used to alleviate pain following thoracoscopy. This technique is known to provide adequate short-term pain relief.
Both paravertebral and intercostal blocks could be interesting adjuncts to patient-controlled devices for pain management following thoracoscopic procedures.
This study will compare the efficacy of preoperative paravertebral nerve blockade to intercostal nerve blockade performed before skin closure to PCA alone to reduce the intensity of pain following thoracoscopic procedures. All patients will have a PCA device as their primary analgesic modality.
- Conditions
- Postoperative Pain
- Being tested
- Paravertebral nerve blockade, Intercostal nerve blockade, Patient Controlled Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral nerve blockadeProcedure or surgery
Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
Intercostal nerve blockadeProcedure or surgery
Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.
Patient Controlled AnalgesiaProcedure or surgery
Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral nerve blockade | Experimental | A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room. Receives: Procedure: Paravertebral nerve blockade |
| Intercostal nerve blockade | Active comparator | Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room. Receives: Procedure: Intercostal nerve blockade |
| Patient Controlled Analgesia (PCA) | Active comparator | Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room. Receives: Procedure: Patient Controlled Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of postoperative pain
Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.
Measured: From arrival in the recovery room until 48 hours following surgery
Secondary outcomes (6)
Opioid consumption
Measured: From surgery until 48 hours following surgery
Patient's satisfaction with pain relief
Patient's satisfaction with pain relief will be assessed using a scale from 1 to 4 (1=very dissatisfied, 4=very satisfied)
Measured: From surgery until 48 hours following surgery
Incidence of chronic pain
Incidence of chronic pain will be assessed using the Brief Pain Inventory questionnaire (BPI)
Measured: Six months after surgery
Length of stay in the recovery room
Measured: From arrival to discharge from the recovery room (an expected average of one hour)
Length of stay in the intermediate intensive care unit
Measured: From arrival to discharge from the intermediate intensive care unit (an expected average of one day)
Length of stay in the hospital
Measured: From surgery to discharge from the hospital (an expected average of 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Sébastien Garneau, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715701
- Sponsor's protocol ID
- SG2012-003
- Status last verified
- Jun 2014
- First submitted
- 25 Oct 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multilevel Thoracic Paravertebral Nerve Blockade to Reduce Postoperative Pain Following Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01715701
- Acronym / sponsor ID
- SG2012-003
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Oct 2012 (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 preoperative multilevel thoracic paravertebral nerve blockade compared to intercostal nerve blockade performed at the end of surgery on the intensity of postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality.
- The incidence of chronic pain at 6 months following video-assisted thoracic surgery.
- The impact of preoperative multilevel paravertebral nerve blockade on patients' quality of life at 6 months following surgery compared to intercostal nerve blockade and to a control group using PCA alone.
Hypothesis:
- The basic hypothesis of this study is that preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will provide superior postoperative analgesia and lower opioid consumption compared to PCA alone during the first 24 hours following surgery.
- Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence of chronic pain at 6 months following surgery.
- Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will shorten the length of stay in the intermediate intensive care unit and shorten the hospital stay.
- Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the end of surgery will reduce postoperative pulmonary complications.
Detailed description
Video-assisted thoracoscopy is increasing in popularity. Although it is considered a less invasive treatment than thoracotomy, patients have reported moderate to severe pain of variable duration. Benefits of adequate analgesia no longer need to be demonstrated. Optimal analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances patient's satisfaction and quality of life following surgery. Furthermore, adequate postoperative analgesia may reduce the occurrence of chronic pain. The incidence of chronic pain following thoracoscopic procedures ranges from 20-47%.
The ideal postoperative analgesia regimen for the pain related to thoracoscopy has not been elucidated.
Systemic opioids given through patient-controlled devices (PCA) may be used after thoracoscopic procedures but the analgesic effect can be limited and undesirable side-effects may occur.
Thoracic epidural has emerged as the preferred pain control technique following thoracotomy. However, the role of epidural analgesia after thoracoscopy remains debatable. Side-effects may outweigh the benefits of the technique in the context of minimally invasive surgeries.
Paravertebral blockade is an alternative to epidural analgesia. The duration of pain relief associated with this technique may vary from 4 to 48 hours. Its effectiveness has been shown to be equal or superior to that of epidural analgesia for post-thoracotomy pain. Its popularity for pain management following thoracotomy has promoted its use after thoracoscopic procedures. Preoperative paravertebral blockade could also result in a reduction of chronic pain following surgery.
Intercostal nerve blockade is widely used to alleviate pain following thoracoscopy. This technique is known to provide adequate short-term pain relief.
Both paravertebral and intercostal blocks could be interesting adjuncts to patient-controlled devices for pain management following thoracoscopic procedures.
This study will compare the efficacy of preoperative paravertebral nerve blockade to intercostal nerve blockade performed before skin closure to PCA alone to reduce the intensity of pain following thoracoscopic procedures. All patients will have a PCA device as their primary analgesic modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paravertebral nerve blockade | Experimental | Procedure: Paravertebral nerve blockadeA multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room. |
| Intercostal nerve blockade | Active comparator | Procedure: Intercostal nerve blockadePrior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room. |
| Patient Controlled Analgesia (PCA) | Active comparator | Procedure: Patient Controlled AnalgesiaPrior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for an elective or emergency thoracoscopic surgery
- Physical status 1-4
Key exclusion criteria (8 listed)
- Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local infection at the site of injection, spinal deformity)
- Severe renal or hepatic insufficiency
- A known allergy to local anesthetics, morphine or hydromorphone
- The inability to understand a verbal numerical pain scale (VNPS) despite previous instruction
- Preexisting pain at the site of the surgical incision
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 |
|---|---|---|
| Paravertebral nerve blockadeParavertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine. | Procedure or surgery | Paravertebral nerve blockade |
| Intercostal nerve blockadeIntercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine. | Procedure or surgery | Intercostal nerve blockade |
| Patient Controlled AnalgesiaSimulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine. | Procedure or surgery | Patient Controlled Analgesia (PCA) |
Primary outcome
Intensity of postoperative pain
Time frame: From arrival in the recovery room until 48 hours following surgery
Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.
6 secondary outcomes
Opioid consumption
Time frame: From surgery until 48 hours following surgery
Patient's satisfaction with pain relief
Time frame: From surgery until 48 hours following surgery
Incidence of chronic pain
Time frame: Six months after surgery
Length of stay in the recovery room
Time frame: From arrival to discharge from the recovery room (an expected average of one hour)
Length of stay in the intermediate intensive care unit
Time frame: From arrival to discharge from the intermediate intensive care unit (an expected average of one day)
Length of stay in the hospital
Time frame: From surgery to discharge from the hospital (an expected average of 2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
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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.
Sébastien 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 Paravertebral nerve blockade and Intercostal nerve blockade 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 9 Jun 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: From arrival in the recovery room until 48 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 9 Jun 2014.