Clinical trial NCT02886429: Post- Thoracotomy Paravertebral Block
Official title: Safety and Efficacy of Ultrasound Guided Paravertebral Dexmedetomidine for Postoperative Pain Relief in Video Assisted Thoracoscopy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: dexmedetomidine
bupivacaine
Ultrasound guided paravertebral block
pain
post-thoracotomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. ASA IV and V
2. Liver impairment
3. Renal impairment
4. allergy to the drugs used
5. Known contraindication for regional techniques such as:

   * Infection near the site of the needle insertion
   * Coagulopathy
   * Anti-coagulation therapy,

Primary outcomes:
measure: post-thoracotomy pain
timeFrame: within first 24 hours after Video Assisted Thoracoscopy Surgery
Secondary outcomes:
measure: pulmonary function tests
timeFrame: within first 24 hours after Video Assisted Thoracoscopy Surgery
measure: rescue analgesia
timeFrame: within first 24 hours after Video Assisted Thoracoscopy Surgery
measure: sedation score
timeFrame: within first 24 hours after Video Assisted Thoracoscopy Surgery
measure: nausea, vomiting
timeFrame: within first 24 hours after Video Assisted Thoracoscopy Surgery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate professor of anesthesia
name: Sayed K Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References: