Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Study Overview
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Brief Summary
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Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine & IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.

Detailed Description
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So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.

Official Title
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Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures

Conditions
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Lower Abdominal Oncologic Surgery

Intervention / Treatment
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* Drug: Placebo-nalbuphine
* Drug: Dexamethasone-nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical class I or II. Undergoing laparotomy Undergoing oophorectomy Undergoing hysterectomy Undergoing rectal mass excision Exclusion Criteria: Patient refusal. Hypersensitivity to amide local anesthetics. General contraindications to spinal anesthesia. Cardiac diseases. Hepatic failure. Renal failure. Respiratory failure. Communication barriers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo-nalbuphine<br>Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% | Drug: Placebo-nalbuphine<br>* Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%<br>|
| Active Comparator: Dexamethasone-nalbuphine<br>Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5% | Drug: Dexamethasone-nalbuphine<br>* Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain visual analog score (0: no pain, 100: worst imaginable pain) | For 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting | (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting) | For 24 hours after surgery | 
| Sensory recovery | Regression to S1 spinal segment as tested with cold sensation | For 5 hours after induction of anaesthesia | 
| Motor recovery | The time until decreased a modified Bromage score of 0 (i.e. full leg movement) | For 5 hours after induction of anaesthesia | 
| First analgesic request | Time to first request of rescue analgesic | For 12 hours after induction of anaesthesia | 
| Intraoperative heart rate changes | Changes in heart rate during surgery | For 3 hours after induction of anaesthesia | 
| Intraoperative mean arterial blood pressure changes | Changes in mean arterial blood pressure during surgery | For 3 hours after induction of anaesthesia | 
| Postoperative heart rate changes | Changes in heart rate after surgery | For 24 hours after surgery | 
| Postoperative mean arterial blood pressure changes | Changes in mean arterial blood pressure after surgery | For 24 hours after surgery | 
| Cumulative use of antiemetic | Cumulative use of metoclopramide and ondansetron after surgery | for 24 hrs after surgery | 
| Cumulative use of rescue intravenous ketorolac | Rescue use of ketorolac in case of severe pain conditions | for 24 hrs after surgery | 
| Cumulative use of rescue intravenous nalbuphine | Rescue use of nalbuphine in case of severe pain conditions | For 24 hours after surgery |