The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.
Overview
- Phase
- Phase 4
- Intervention
- intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg
- Conditions
- Inguinal Hernia
- Sponsor
- Ankara University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Sensory and motor block
- Status
- Completed
- Last Updated
- 12 years ago
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.
Investigators
Basak Ceyda MECO
MD, DESA
Ankara University
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
Arms & Interventions
intrathecal morphine 0.1 mg
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
Intervention: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg
intrathecal morphine 0.1 mg
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
Intervention: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland
intrathecal morphine 0.1 mg
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
Intervention: intravenous cannulation and premedication
0.4 mg of intrathecal morphine
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.
Intervention: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg
0.4 mg of intrathecal morphine
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.
Intervention: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland
0.4 mg of intrathecal morphine
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.
Intervention: intravenous cannulation and premedication
Outcomes
Primary Outcomes
Sensory and motor block
Time Frame: 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.
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.
Secondary Outcomes
- first mobilisation, first urination and first analgesic times(after the procedure, during the first 24 hours)