Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief

Phase 3

Completed

• Conditions: Post Thoracotomy Pain
• Interventions: Combination Product: Thoracic paravertebral block; Drug: Systemic analgesia

• Registration Number: NCT04482192
• Lead Sponsor: Zagazig University

Brief Summary

to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.

Detailed Description

Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85 and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.

Eighty two participants were assessed for eligibility criteria to be included in the study, 18 participants were excluded pre-randomization, and one participant was excluded post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and systemic analgesia group (SA group) included 31 participants.

Technique of intraoperative paravertebral catheter insertion:

The investigators used the technique that was described by Sabanathan et al in 1988\[14\] and modified by them in 1990 \[15\]. After completing the surgical pulmonary procedure and with the chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is raised from the posterior chest wall to the vertebral body and for two spaces above and below the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted percutaneously through a low posterior interspace. The needle is advanced until the tip appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural catheter is advanced into the created pouch and the needle is withdrawn. Using a curved forceps, a small defect is done in the extrapleural fascia to be directly in the paravertebral space. The cannula is passed to the paravertebral space through the defect and advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected through the catheter and the chest is closed as usual with one or two intercostal drainage tubes according to the surgical procedure.

Protocol of analgesia:

All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30 mg ketorolac half an hour before the end of surgery.

Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse was responsible for handling the analgesia regimen and another nurse was responsible for recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.

Study Timeline

• Study Start: 2015-06-15
• Primary Completion: 2020-01-31
• Study Completion: 2020-03-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• • Elective posterolateral thoracotomy surgery

  • American Society of Anesthesiologists (ASA) physical status of II and III

Exclusion Criteria

• • lack of patient consent.

  • patients younger than 18 years,
  • emergency surgery,
  • previous thoracotomy,
  • drug addiction,
  • allergy to paracetamol (acetaminophen) or ketorolac,
  • coagulopathy,
  • hepatic dysfunction,
  • chronic renal failure,
  • history of gastric ulcer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic paravertebral block group	Thoracic paravertebral block	Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon.
Systemic analgesia group	Systemic analgesia	patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days

Primary Outcome Measures

Name	Time	Method
Pain score on visual analogue scale (VAS) at rest	24 hours after operation	Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
Pain score on visual analogue scale (VAS) on coughing	24 hours after operation	Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption	end of first postoperative day	The summation of morphine consumption of the participant
Forced vital capacity (FVC)	24 hours after operation	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
Forced expiratory volume in 1s (FEV1)	24 hours after operation	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
Peak expiratory flow rate (PEFR)	24 hours after operation	measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)