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

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ClinicalTrials.gov Identifier: NCT02237664
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief 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 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.


Condition or disease Intervention/treatment Phase
Video-assisted Thoracoscopic Surgery Procedure: Continuous paravertebral analgesia (C-PVB) Procedure: Patient-controlled paravertebral analgesia (PC-PVB) Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient-Controlled Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patient-controlled paravertebral analgesia (PC-PVB)
Patient-controlled paravertebral analgesia
Procedure: 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

Placebo Comparator: Continuous paravertebral analgesia (C-PVB)
Continuous paravertebral analgesia
Procedure: 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




Primary Outcome Measures :
  1. Pain scores [ Time Frame: 48 hours after surgery ]
    Pain scores on a 100-mm-long visual analog score (VAS) at rest and on cough


Secondary Outcome Measures :
  1. Hemodynamic variables [ Time Frame: 48 hours after surgery ]
    Heart rate

  2. Number of bolus demands [ Time Frame: 48 after surgery ]
    The number of bolus demands

  3. Actual number of boluses [ Time Frame: 48 hours after surgery ]
    the actual number of on demand boluses of the patient-controlled analgesia received by the patient

  4. Total volume of administered bupivacaine [ Time Frame: 48 hours after surgery ]
    total volume of bupivacaine administered during the first 48 hours after surgery

  5. Rescue analgesic requirements [ Time Frame: 48 hours after surgery ]
    rescue analgesic requirements

  6. Requirement for antiemetic medication [ Time Frame: 48 hours after surgery ]
    Requirement for antiemetic medications

  7. Overall patient satisfaction [ Time Frame: 48 hours after surgery ]
    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.

  8. Sedation scores [ Time Frame: 48 hours after surgery ]
    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).

  9. Pulmonary function tests [ Time Frame: 24 hours before surgery, 72 hours after surgery ]
    , forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow rate (PEFR) will be recorded



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237664


Contacts
Contact: Mohamed R El Tahan, MD +966 13 865 1193 mohamedrefaateltahan@yahoo.com
Contact: Abdulmohsin A Al Ghamdi, MD +966 50 581 4737 mohsenkfu@hotmail.com

Locations
Saudi Arabia
King Fahd Hospital of the University Recruiting
Khobar, Eastern, Saudi Arabia, 31952
Contact: Abdulmohsen A Al Ghamdi, MD    +966 13 8966666 ext 2021    mohsenkfu@hotmail.com   
Sub-Investigator: Alaa M Khidr, MD         
Sub-Investigator: Abdulmohsen A Al Ghamdi, MD         
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Yasser Al Jehani, MD Chairman of Surgery Dept
Study Director: Mohamed R El Tahan, MD Imam Abdulrahman Bin Faisal University

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02237664     History of Changes
Other Study ID Numbers: UD-2015-16-P1Anesth
GPAnesth-1 ( Other Identifier: Dammam University )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Keywords provided by Dammam University:
Thoracoscopy
Patient-controlled analgesia
Paravertebral analgesia