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

NCT02237664 | Unknown Phase 1 DMC

• 2 other identifiers: UD-2015-16-P1AnesthGPAnesth-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Video-assisted Thoracoscopic Surgery

Keywords

Thoracoscopy; Patient-controlled analgesia; Paravertebral analgesia

Outcome Measures

Primary Outcomes (1)

• Pain scores

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

  48 hours after surgery

Secondary Outcomes (9)

• Hemodynamic variables

  48 hours after surgery

• Number of bolus demands

  48 after surgery

• Actual number of boluses

  48 hours after surgery

• Total volume of administered bupivacaine

  48 hours after surgery

• Rescue analgesic requirements

  48 hours after surgery

Study Arms (2)

Patient-controlled paravertebral analgesia (PC-PVB)

ACTIVE COMPARATOR

Patient-controlled paravertebral analgesia

Procedure: Patient-controlled paravertebral analgesia (PC-PVB)

Continuous paravertebral analgesia (C-PVB)

PLACEBO COMPARATOR

Continuous paravertebral analgesia

Procedure: Continuous paravertebral analgesia (C-PVB)

Interventions

Continuous paravertebral analgesia (C-PVB) PROCEDURE

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

Continuous paravertebral analgesia (C-PVB)

Patient-controlled paravertebral analgesia (PC-PVB) PROCEDURE

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

Patient-controlled paravertebral analgesia (PC-PVB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Khobar, Eastern Province, 31952, Saudi Arabia

RECRUITING

Study Officials

• Yasser Al Jehani, MD

  Chairman of Surgery Dept

  PRINCIPAL INVESTIGATOR

• Mohamed R El Tahan, MD

  Imam Abdulrahman Bin Faisal University

  STUDY DIRECTOR

Central Study Contacts

Mohamed R El Tahan, MD

CONTACT

+966 13 865 1193; mohamedrefaateltahan@yahoo.com

Abdulmohsin A Al Ghamdi, MD

CONTACT

+966 50 581 4737; mohsenkfu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 11, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

SA (1)