Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to the 1st rescue analgesia
Study Overview
Brief Summary
The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.
Detailed Description
Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.
As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-III.
- •Scheduled for open thoracotomy.
Exclusion Criteria
- •Patients with neurological or intellectual disability.
- •Infection at the injection site.
- •Opioid addiction.
- •Allergic reaction to local anesthetics.
- •Coagulation abnormalities.
- •Drug abuse.
- •Pregnancy.
- •Severe liver and/or renal failure.
- •Uncontrolled hypertension.
- •Severe cardiovascular problems.
- •Diabetes mellitus.
Arms & Interventions
Ketamine group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
Intervention: Ketamine (Drug)
Ketamine group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
Intervention: Bupivacaine (Drug)
Dex group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
Intervention: Dexmedetomidine (Drug)
Dex group
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
Time to the 1st rescue analgesia
Time Frame: 48 hours postoperative.
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Secondary Outcomes
- Intraoperative fentanyl consumption(Intraoperative)
- Total morphine consumption in the 1st 24hr and 48 hr(48 hours postoperatively.)
- Degree of pain(48 hours postoperatively.)
- Heart rate(Till the end of surgery.)
- The incidence of adverse events(48 hours postoperative)
- Mean arterial blood(Till the end of surgery.)
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University