Intrathecal Morphine for Inguinal Hernia Repair.

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the effects of two different doses of intrathecal morphine (0.1 mg and 0.4 mg) combined with 7.5 mg of heavy bupivacaine on postoperative block regression times, postoperative analgesia and the severity of side effects, for inguinal hernia repairs.

Detailed Description
-----------------
The purpose of this study was to compare spinal anesthesia with low dose heavy bupivacaine combined with 0.1 mg or 0.4 mg of morphine in inguinal hernia repair surgeries. Anesthesia onset time (sensory and motor blocks) as well as postoperative recovery (first mobilisation, first voiding) time were compared. Also the postoperative pain management and side effects (nausea, vomiting and pruritus) were assessed.

Official Title
-----------------
The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.

Conditions
-----------------
Inguinal Hernia, Nausea, Vomiting, Pruritus, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg
* Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg
* Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland
* Drug: intravenous cannulation and premedication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anaesthesiology physical status I-II patients aged 18-65 years undergoing elective unilateral open inguinal hernia repair surgery Exclusion Criteria: contraindications to spinal anesthesia central or peripheral neuropathies severe respiratory or cardiac diseases chronic analgesic use history of substance abuse allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intrathecal morphine 0.1 mg<br>After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive a spinal anaesthesia with 0.1 mg morphine combined with 7.5 mg heavy bupivacaine | Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg<br> <br> Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland<br>* electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure<br>Drug: intravenous cannulation and premedication<br>* 18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given<br>|
| Active Comparator: 0.4 mg of intrathecal morphine<br>After routine monitorisation, intravenous cannulation and premedication, patients in this group will receive spinal anesthesia with 0.4 mg of morphine combined with 7.5 mg of heavy bupivacaine. | Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg<br> <br> Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland<br>* electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure<br>Drug: intravenous cannulation and premedication<br>* 18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory and motor block | Sensory and motor block produced by the spinal anaesthesia will be assessed prior the procedure to define readiness for surgery and then once the procedure is over, sensory and motor block levels will be assessed one more time to follow up the block regression times. Motor block will be assessed with Bromage scale (0: no motor block, 1: hip blocked; 2: hip and knee blocked; 3: hip, knee and ankle blocked). Sensory block will be assessed using loss of pinprick sensation. The onset of surgical anesthesia is defined as loss of pinprick sensation at ≥ T10 with a Bromage score ≥ 2. | The change in motor block and sensory block levels will be assessed after performing spinal block, every 5 minutes for 30 minutes and then at the end of the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first mobilisation, first urination and first analgesic times | all patients will be followed up during the first postoperative 24 hours to assess the first mobilisation, first voiding and first analgesic requirement times. | after the procedure, during the first 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal anaesthesia, morphine, postoperative analgesia, vomiting