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Completed

NCT Number: NCT02886429

Post- Thoracotomy Paravertebral Block

Postoperative pain is the most undesired consequence of surgery, and if not managed adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to reveal that postoperative pain is insufficiently managed throughout the first world, let alone in the Third World. An American survey over 20 years showed that only one in four patients had adequate relief of postoperative pain. This has led recovery room protocols to include pain as a fifth vital sign that needs to be addressed before patients are discharged to the ward

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

This prospective, randomized, double-blinded, parallel assignment clinical trial will be done after receiving approval from the local ethics committee of the Faculty of Medicine, Assiut University. A written informed consent will be taken after discussing a detailed description of the study with the patients.

Patients will be allocated randomly into two equal groups by computer programs and will be contained in sealed opaque envelopes.

Patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation. Patients will be monitored with ECG, non-invasive blood pressure, heart rate, temperature, oxygen saturation, exhaled CO2 (end tidal capnography), and train of four. In both groups, general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation will be facilitated with cisatracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). Fentanyl (0.5mcg/kg) will be repeated if heart rate (HR) and/or mean arterial pressure (MAP) rise 20 % above baseline values. After the end of anesthesia induction and before surgical procedure Technique of ultrasound guided paravertebral block will be done in both groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I, II and III.
  • In the age ranged between 18 up to 60 years.
  • Elective video-assisted thoracoscopy

Exclusion criteria

  • ASA IV and V
  • Liver impairment
  • Renal impairment
  • allergy to the drugs used
  • Known contraindication for regional techniques such as:
  • Infection near the site of the needle insertion
  • Coagulopathy
  • Anti-coagulation therapy,

Treatment and study plan

Bupivacaine

Drug

Ultrasound guided paravertebral block with bupivacaine

Other names: Marcaine

Dexmedetomidine

Drug

Ultrasound guided paravertebral block with dexmedetomidine

Other names: Precedex

Primary outcomes

  1. post-thoracotomy pain

    Time frame: within first 24 hours after Video Assisted Thoracoscopy Surgery

    • Pain scores at rest and on coughing will be recorded using visual analogue scale (VAS) pain intensities at rest and during coughing/movement assessed by VAS score. The quality of effective analgesia will be expressed as VAS values derived from the VAS pain score, at rest and during coughing during each assessment period (2 h, at 4, 8 and 24 h).

Secondary outcomes

  1. pulmonary function tests

    Time frame: within first 24 hours after Video Assisted Thoracoscopy Surgery

    done preoperatively and at postoperative period

  2. rescue analgesia

    Time frame: within first 24 hours after Video Assisted Thoracoscopy Surgery

    Consumption of IV rescue analgesia attained with ketorolac tromethamine (30 mg per dose).

  3. sedation score

    Time frame: within first 24 hours after Video Assisted Thoracoscopy Surgery

    Richmond Agitation Sedation Score

  4. nausea, vomiting

    Time frame: within first 24 hours after Video Assisted Thoracoscopy Surgery

    nausea, vomiting

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Safety and Efficacy of Ultrasound Guided Paravertebral Dexmedetomidine for Postoperative Pain Relief in Video Assisted Thoracoscopy Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2016
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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