Pain, Postoperative
Conditions
Keywords
dexmedetomidine, bupivacaine, Ultrasound guided paravertebral block, pain, post-thoracotomy
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.
Interventions
DRUGBupivacaine
Ultrasound guided paravertebral block with bupivacaine
DRUGDexmedetomidine
Ultrasound guided paravertebral block with dexmedetomidine
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| pulmonary function tests | within first 24 hours after Video Assisted Thoracoscopy Surgery | done preoperatively and at postoperative period |
| rescue analgesia | within first 24 hours after Video Assisted Thoracoscopy Surgery | Consumption of IV rescue analgesia attained with ketorolac tromethamine (30 mg per dose). |
| sedation score | within first 24 hours after Video Assisted Thoracoscopy Surgery | Richmond Agitation Sedation Score |
| nausea, vomiting | within first 24 hours after Video Assisted Thoracoscopy Surgery | nausea, vomiting |
Countries
Egypt
Outcome results
None listed