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Video-assisted Thoracoscopic SurgeryPhase 1/2NCT02237664

Patient-Controlled Thoracic Paravertebral Block After Video-Assisted Thoracoscopic Surgery

A Phase 1/2 study testing Continuous paravertebral analgesia (C-PVB) in people with Video-assisted Thoracoscopic Surgery, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Thoracic surgery is commonly associated with severe postoperative pain and marked impairment of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is assumed to result in better quality of life and less postoperative pain compared with standard open thoracotomy, other investigators have… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Video-assisted Thoracoscopic Surgery
What is being tested?
Continuous paravertebral analgesia (C-PVB)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteSaudi Arabia
Study dates
Jan 2015to Jun 2020
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status II-III.
  • Use of postoperative thoracic paravertebral analgesia

Who cannot join

  • Cardiac disease
  • Pulmonary disease
  • Renal disease
  • Hepatic disease
  • Neuropsychiatric disease
  • Pregnancy
Show all 17Show fewer
  • Bleeding disorder
  • Severe anatomical abnormalities of the vertebral column or ribs
  • Allergy to study medications
  • Other contraindications to paravertebral analgesia
  • Body mass index (BMI) ≥ 35 kg m-2
  • Body weight less than 50 kg
  • Emergency surgery
  • Preoperative pain score > 70 mm on visual analogue scale (VAS)
  • Drug or alcohol abuse
  • Chronic pain condition requiring daily intake of analgesics
  • Language or mental disorders

Trial locations and contacts

1 site in 1 country.

Abdulmohsin A Al Ghamdi, MD contact

+966 50 581 4737

mohsenkfu@hotmail.com

Saudi Arabia1 site, 1 recruiting
  • King Fahd Hospital of the University

    Khobar, Eastern Province, 31952

    Abdulmohsen A Al Ghamdi, MD, +966 13 8966666 ext. 2021, mohsenkfu@hotmail.com

    Alaa M Khidr, MD

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Patient-Controlled Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

Thoracic surgery is commonly associated with severe postoperative pain and marked impairment of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is assumed to result in better quality of life and less postoperative pain compared with standard open thoracotomy, other investigators have reported comparable patient-reported physical component summary and pain scores after VATS and thoracotomy during the first 12 months after lung resection.2 That study was non-randomized and 41% of the included patients did not complete the follow-up period.2 VATS has recently been increasing in popularity as a fast-track surgery with potential enhanced recovery after surgery.

Variety of approaches exist to manage pain after thoracotomy which could attenuate post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many decades to be the best method of pain relief after major thoracic surgery. In previous meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB) has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing thoracotomy.

Read more

Additionally, PVB has a better side-effect profile, lower rates of failed block and is associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7

Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative analgesia, that allows a perfect match between intensity of pain and analgesic delivery, improves the quality of analgesia and decreases the cumulative analgesic consumption. Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background infusion during labour gave patients a sense of control over their analgesia, reduced the total dose of local anesthetic administered, and had less motor block than those who receive continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have reported comparable analgesia after thoracic surgery with the use of either patient-controlled PVB had with the use of intrathecal morphine, that study was not controlled and included few patients.14

The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of postoperative analgesia and pulmonary function after VATS has not yet been studied.

Read the detailed description

We hypothesizes that the use of patient-controlled paravertebral blockade (PC-PVB) after VATS will be associated with lower pain scores and less pulmonary dysfunction than continuous paravertebral blockade (PVB).

Following obtaining of the Local Ethics Committee approval and informed patient consent, 62 patients, aged 18 -70 years, American Society of Anesthesiologists (ASA) physical status II-III, undergoing elective VATS using postoperative thoracic paravertebral analgesia will be included in this prospective, randomized, controlled, double-blind study.

Before operation, forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow rate (PEFR), were measured. On the morning before surgery, the patients will be instructed in the use of the PCA pump and a VAS. The patients will be asked to rate their experienced pain using the VAS from 0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain.

Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors includes electrocardiograph, non-invasive blood pressure, and pulse oximeter. All patients will be premedicated with iv midazolam 0.01-0.03 mg kg-1.

Before the induction of general anesthesia, paravertebral space ipsilateral to the thoracostomy will be identified 3 cm lateral to the spinous process of T5-8 with ultrasound-guidance (USG) using a high-frequency linear array probe of a Sonosite MTurbo ultrasound machine (MicroMaxxs ultrasound system, Sonosite Inc, Bothell, WA). After the probe was placed at the level of the T5-6 interspace, the apex of the paravertebral space will be visualized as a wedge-shaped hypoechoic space surrounded by the hyperechoic line of the pleura below and the internal intercostal membrane above. An 18 G Tuohy needle (B. Braun, Germany) will be inserted in a lateral-to-medial direction using an in-plane approach and will be kept advancing until the needle tip penetrates the internal intercostal membrane.7 A 20-G epidural catheter (B. Braun, Germany) will be introduced through Tuohy needle and advanced 3 cm into the paravertebral space. After gentle aspiration, a test dose of 3 mL of bupivacaine 0.25% with epinephrine 5 µg mL-1 will be administered through the catheter. If no significant rise in heart rate or arterial pressure will be observed, a bolus of 0.3 mL kg-1 of bupivacaine 0.25% with epinephrine (5 µg mL-1), followed by continuous paravertebral infusion of bupivacaine 0.25% and fentanyl 2 µg mL-1 at 0.1 mL kg-1 h-1 intraoperatively.15

In all patients, standard monitors and state and response entropy (SE and RE, respectively, GE Healthcare, Helsinki, Finland) based-depth of anesthesia will be applied. The radial artery will be catheterized. Anesthetic technique will be standardized in all studied patients. After preoxygenation, general anesthesia will be induced with propofol 1.5-3 mg kg-1 and target-controlled infusion (TCI) of remifentanil at an effect-site concentration (Ce) of 4 ng mL-1, to achieve the SE values below 50 and the difference between RE and SE below 10. Rocuronium (0.5 mg kg-1) will be given to facilitate the endobronchial intubation with a left-double lumen endobronchial tube and the correct position of its tip will be confirmed with a fiberoptic bronchoscope.

Anaesthesia will be maintained with 0.7-1.5 minimum alveolar concentration of sevoflurane and remifentanil Ce of 2-4 ng mL-1 to maintain the SE values below 50, the difference between RE and SE below 10 and the mean arterial blood pressure (MAP) and heart rate <20% of baseline values. Rocuronium increments will be used to maintain surgical relaxation.

Two lung ventilation (TLV) will be instituted using fraction of inspired oxygen (FiO2) of 0.4 in air, tidal volume (VT) of 8 mL kg-1, inspiratory to expiratory (I: E) ratio of 1:2.5 and PEEP of 5 cm H2O, and respiratory rate will be adjusted to achieve an arterial carbon dioxide tension (PaCO2) of 4.7-6 kPa. During one-lung ventilation (OLV), the dependent lung will be ventilated with a FiO2 of 1.0, VT of 6 mL kg-1 and I: E ratio, PEEP, and respiratory rate, will be maintained as during TLV. The dependent lung will be recruited at 30-minute intervals by increasing the inspiratory pressure to 40 cmH2O for 10 seconds.

All surgical procedures will be performed by the same surgeons who will be blinded for the study group. The VATS procedure will begin with the exploration of the pleural cavity using a 30° video thoracoscopic camera through 1.5 cm single skin incision with the use of 1-3 trocars which enables the thoracoscopic instruments to move the lung.

At the end of surgery, the nondependent lung will be re-expanded, the remifentanil and sevoflurane will be discontinued after chest closure and skin closure, respectively, and the residual neuromuscular blockade will be antagonized.

During working hours of the first 48 hours, the patients will be visited by an acute pain nurse and/or a consultant anesthesiologist, who will interview each patient regarding satisfaction with postoperative analgesia. After hours, an anesthetic registrar will be available to review analgesia management. All patients will receive multimodal analgesia consisting of regular IV paracetamol (1 g four times a day) and IV lornoxicam (8 mg two times a day) for postoperative pain relief.

Breakthrough pain, defined as pain VAS > 30 mm, will be treated with a bolus of 0.1 mL kg-1 of paravertebral medication administered through the pump. No additional medication will be given if the pain VAS < 30 mm. If after 15 minutes pain VAS persists greater than 30, additional 0.1 mL kg-1 of the paravertebral medication will be given. If the patient still has a pain VAS > 30 despite breakthrough pain intervention, then the patient will be connected to PCA with intravenous morphine 1 mg, with a lockout interval of 8 minutes and a maximum 4-hourly limit of 30 mg.5

Being tested
Continuous paravertebral analgesia (C-PVB), Patient-controlled paravertebral analgesia (PC-PVB)
Keywords
Thoracoscopy, Patient-controlled analgesia, Paravertebral analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous paravertebral analgesia (C-PVB)Procedure or surgery

    Patients will receive continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1

  • Patient-controlled paravertebral analgesia (PC-PVB)Procedure or surgery

    Patients will receive background continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1 with patient demand bolus dose of 3 mL and lockout time of 15 min with a 20 mL h-1 maximum dose, irrespective of their age

Study groups in NCT02237664
Study groupRoleWhat they receive
Patient-controlled paravertebral analgesia (PC-PVB)Active comparatorPatient-controlled paravertebral analgesia
Receives: Procedure: Patient-controlled paravertebral analgesia (PC-PVB)
Continuous paravertebral analgesia (C-PVB)Placebo comparatorContinuous paravertebral analgesia
Receives: Procedure: Continuous paravertebral analgesia (C-PVB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain scores

    Pain scores on a 100-mm-long visual analog score (VAS) at rest and on cough

    Measured: 48 hours after surgery

Secondary outcomes (9)
  1. Hemodynamic variables

    Heart rate

    Measured: 48 hours after surgery

  2. Number of bolus demands

    The number of bolus demands

    Measured: 48 after surgery

  3. Actual number of boluses

    the actual number of on demand boluses of the patient-controlled analgesia received by the patient

    Measured: 48 hours after surgery

  4. Total volume of administered bupivacaine

    total volume of bupivacaine administered during the first 48 hours after surgery

    Measured: 48 hours after surgery

  5. Rescue analgesic requirements

    rescue analgesic requirements

    Measured: 48 hours after surgery

  6. Requirement for antiemetic medication

    Requirement for antiemetic medications

    Measured: 48 hours after surgery

  7. Overall patient satisfaction

    Overall patient satisfaction will be recorded on a 100-mm visual analog scale (VAS) (0 mm = completely dissatisfied, 100 mm = completely satisfied) after catheter removal.

    Measured: 48 hours after surgery

  8. Sedation scores

    Patient sedation will be assessed 4 hourly on a five-point sedation score (1, wide awake; 2, drowsy or dozing intermittently; 3, mostly sleeping but easily awakened; 4, asleep, difficulty responding to verbal commands; 5, awakened only by shaking).

    Measured: 48 hours after surgery

  9. Pulmonary function tests

    , forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow rate (PEFR) will be recorded

    Measured: 24 hours before surgery, 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237664
Sponsor's protocol ID
UD-2015-16-P1Anesth
Other IDs
GPAnesth-1
Status last verified
Mar 2019
First submitted
8 Sep 2014
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Continuous paravertebral analgesia (C-PVB) in people with Video-assisted Thoracoscopic Surgery, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

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 17 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: status not confirmed, as of the sponsor's last update on 20 Mar 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed R El Tahan, MD (+966 13 865 1193, mohamedrefaateltahan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores (time frame: 48 hours after 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 20 Mar 2019.

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