Video-assisted Thoracoscopic Surgery Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | June 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists (ASA) physical status II-III. - Use of postoperative thoracic paravertebral analgesia Exclusion Criteria: - Cardiac disease - Pulmonary disease - Renal disease - Hepatic disease - Neuropsychiatric disease - Pregnancy - 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 |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Fahd Hospital of the University | Khobar | Eastern |
Lead Sponsor | Collaborator |
---|---|
Dammam University |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain scores | Pain scores on a 100-mm-long visual analog score (VAS) at rest and on cough | 48 hours after surgery | |
Secondary | Hemodynamic variables | Heart rate | 48 hours after surgery | |
Secondary | Number of bolus demands | The number of bolus demands | 48 after surgery | |
Secondary | Actual number of boluses | the actual number of on demand boluses of the patient-controlled analgesia received by the patient | 48 hours after surgery | |
Secondary | Total volume of administered bupivacaine | total volume of bupivacaine administered during the first 48 hours after surgery | 48 hours after surgery | |
Secondary | Rescue analgesic requirements | rescue analgesic requirements | 48 hours after surgery | |
Secondary | Requirement for antiemetic medication | Requirement for antiemetic medications | 48 hours after surgery | |
Secondary | 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. | 48 hours after surgery | |
Secondary | 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). | 48 hours after surgery | |
Secondary | Pulmonary function tests | , forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow rate (PEFR) will be recorded | 24 hours before surgery, 72 hours after surgery |
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