Post- Thoracotomy Paravertebral Block

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine; Drug: Dexmedetomidine

• Registration Number: NCT02886429
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-27
• Study First Submitted QC: 2016-08-27
• Study First Posted: 2016-09-01
• Primary Completion: 2018-08
• Study Completion: 2018-10
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-02
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Bupivacaine	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)
Group A	Bupivacaine	Ultrasound guided paravertebral block with bupivacaine group Thirty patients will be given isobaric bupivacaine 0.5% (0.3ml/kg) via paravertebral route.
Group B	Dexmedetomidine	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)

Primary Outcome Measures

Name	Time	Method
post-thoracotomy pain	within first 24 hours after Video Assisted Thoracoscopy Surgery	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt