Post- Thoracotomy Paravertebral Block

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886429
• Other study ID #: IIRB0000871250
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: October 2018

Study information

• Verified date: December 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
Ultrasound guided paravertebral block with bupivacaine
• Dexmedetomidine
Ultrasound guided paravertebral block with dexmedetomidine

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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