Post Operative Analgesic Efficacy of Dexmedetomidine V/S fentanyl as an Adjuvant to Bupivacaine in Thoracic Epidural for Midline Laparotomies
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To compare dexmedetomidine and fentanyl as an adjuvant for bupivacaine in thoracic epidural in terms of duration of post operative analgesia in first 24 hours.
Study Overview
Brief Summary
Large surgical incisions and extensive gut handling and manipulation are involved with upper abdominal surgeries which increases the need for perioperative analgesia. Uncontrolled postoperative pain and pathophysiological response to surgery make these patients prone to high stress and sympathetic activation.
Epidural analgesia is a simple and safe technique that produces effective block with small dose of local anaesthetic. It provides extended post-operative pain control that is superior to that provided by systemic opioids alone. Thoracic epidural analgesia (TEA) provides good postoperative pain relief and facilitates deep breathing exercises and early ambulation. Sympathetic outflow decreases with use of TEA. To achieve desired post-op analgesic effect, invariably large volumes of local anaesthetics are used, thereby increasing the possibilities of local anaesthetic toxicity and deleterious hemodynamic consequences. Opioids like fentanyl have been used traditionally as an adjunct for epidural administration in combination with a lower dose of local anaesthetic to achieve the desired analgesic effect. The addition of opioid does provide a dose sparing effect of local anaesthetic and superior analgesia but there is always a possibility of an increased incidence of nausea, vomiting and respiratory depression.
Dexmedetomidine is an alpha-2 agonist which has got numerous beneficial effects. It acts on both pre and post synaptic sympathetic nerve terminal and central nervous system thereby decreasing the sympathetic outflow and nor-epinephrine release. Dexmedetomidine has an effective sedative, anti-anxiety and analgesic effect. Dexmedetomidine does cause a manageable hypotension and bradycardia but it does not cause opioid related side effects like respiratory depression, nausea and vomiting.
Therefore, we planned to compare the post operative analgesic efficacy of dexmedetomidine vs fentanyl as an adjuvant to bupivacaine in thoracic epidural for midline laparotomies.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients in age group 18-70 years.
- •Posted for elective laparotomy.
- •BMI 18-30 Kg/m
- •ASA grade I, II, III.
Exclusion Criteria
- •Patient refusal.
- •Known allergy to drug used in the study.
- •Patient with ASA grade IV and above.
- •Pre-existing intrinsic or idiopathic coagulopathy.
- •Hepatic, renal or cardiorespiratory failure.
- •Patients with an increase in intracranial pressure.
- •Skin or soft tissue infection at the proposed site of needle insertion.
- •Severe hypovolemia.
- •Pre-existing neurological disease.
- •Emergency laparotomy surgeries.
- •Surgeries lasting for more than 3 hrs.
Outcomes
Primary Outcomes
To compare dexmedetomidine and fentanyl as an adjuvant for bupivacaine in thoracic epidural in terms of duration of post operative analgesia in first 24 hours.
Time Frame: Evaluate on the basis of NRS score at different intervals in first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours.
Secondary Outcomes
- 1. Peri-operative hemodynamic stability(2. Post-operative sedation score)
Investigators
Shikha Gupta
Sardar Patel Medical College
