Post- Thoracotomy Paravertebral Block

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacaine; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Ultrasound guided paravertebral block with bupivacaine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) via paravertebral route.	Drug: Bupivacaine; Ultrasound guided paravertebral block with bupivacaine; Other Names: Marcaine
Active Comparator: Group B; Ultrasound guided paravertebral block with bupivacaine and dexmedetomidine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg) via paravertebral route (Bupivacaine plus Dexmedetomidine)	Drug: Bupivacaine; Ultrasound guided paravertebral block with bupivacaine; Other Names: Marcaine; Drug: Dexmedetomidine; Ultrasound guided paravertebral block with dexmedetomidine; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-thoracotomy pain	5. 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).	within first 24 hours after Video Assisted Thoracoscopy Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary function tests	done preoperatively and at postoperative period	within first 24 hours after Video Assisted Thoracoscopy Surgery
rescue analgesia	Consumption of IV rescue analgesia attained with ketorolac tromethamine (30 mg per dose).	within first 24 hours after Video Assisted Thoracoscopy Surgery
sedation score	Richmond Agitation Sedation Score	within first 24 hours after Video Assisted Thoracoscopy Surgery
nausea, vomiting	nausea, vomiting	within first 24 hours after Video Assisted Thoracoscopy Surgery

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Sayed K Abd-Elshafy, MD, Associate professor of anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 27, 2016
• First Submitted That Met QC Criteria: August 27, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 2, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pain; dexmedetomidine; bupivacaine; Ultrasound guided paravertebral block; post-thoracotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: IIRB0000871250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED