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.
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)
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
Saudi Arabia1 site, 1 recruiting
- 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
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
- Conditions
- Video-assisted Thoracoscopic Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Patient-controlled paravertebral analgesia (PC-PVB) | Active comparator | Patient-controlled paravertebral analgesia Receives: Procedure: Patient-controlled paravertebral analgesia (PC-PVB) |
| Continuous paravertebral analgesia (C-PVB) | Placebo comparator | Continuous 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.
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)
Hemodynamic variables
Heart rate
Measured: 48 hours after surgery
Number of bolus demands
The number of bolus demands
Measured: 48 after surgery
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
Total volume of administered bupivacaine
total volume of bupivacaine administered during the first 48 hours after surgery
Measured: 48 hours after surgery
Rescue analgesic requirements
rescue analgesic requirements
Measured: 48 hours after surgery
Requirement for antiemetic medication
Requirement for antiemetic medications
Measured: 48 hours after surgery
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
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
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.
- First posted11 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracoscopic SurgeryStudies of the same condition, open and under way.
- 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 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)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasser Al Jehani, MD, Principal investigator, Chairman of Surgery DeptMohamed R El Tahan, MD, Study director, Imam Abdulrahman Bin Faisal University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Controlled Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02237664
- Acronym / sponsor ID
- UD-2015-16-P1Anesth
- Conditions
- Video-assisted Thoracoscopic Surgery
- Keywords
- Thoracoscopy, Patient-controlled analgesia, Paravertebral analgesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Sep 2014 (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.
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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled paravertebral analgesia (PC-PVB) | Active comparator | Procedure: Patient-controlled paravertebral analgesia (PC-PVB)Patient-controlled paravertebral analgesia |
| Continuous paravertebral analgesia (C-PVB) | Placebo comparator | Procedure: Continuous paravertebral analgesia (C-PVB)Continuous paravertebral analgesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status II-III.
- Use of postoperative thoracic paravertebral analgesia
Key exclusion criteria (17 listed)
- Cardiac disease
- Pulmonary disease
- Renal disease
- Hepatic disease
- Neuropsychiatric disease
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 paravertebral analgesia (C-PVB)Patients will receive continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1 | Procedure or surgery | Continuous paravertebral analgesia (C-PVB) |
| Patient-controlled paravertebral analgesia (PC-PVB)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 | Procedure or surgery | Patient-controlled paravertebral analgesia (PC-PVB) |
Primary outcome
Pain scores
Time frame: 48 hours after surgery
Pain scores on a 100-mm-long visual analog score (VAS) at rest and on cough
9 secondary outcomes
Hemodynamic variables
Time frame: 48 hours after surgery
Number of bolus demands
Time frame: 48 after surgery
Actual number of boluses
Time frame: 48 hours after surgery
Total volume of administered bupivacaine
Time frame: 48 hours after surgery
Rescue analgesic requirements
Time frame: 48 hours after surgery
Requirement for antiemetic medication
Time frame: 48 hours after surgery
Overall patient satisfaction
Time frame: 48 hours after surgery
Sedation scores
Time frame: 48 hours after surgery
Pulmonary function tests
Time frame: 24 hours before surgery, 72 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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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.
Yasser Al Jehani, MD principal investigator
Chairman of Surgery Dept
Mohamed R El Tahan, MD study director
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
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.