Intrathecal Morphine for Inguinal Hernia Repair.

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

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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Postoperative Pain; Inguinal Hernia; Pruritus
• Intervention / Treatment: Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg; Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; Drug: intravenous cannulation and premedication; Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06700
    • Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg; Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure; Drug: intravenous cannulation and premedication; 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
Active Comparator: 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.	Device: standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland; electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure; Drug: intravenous cannulation and premedication; 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; Drug: intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea, vomiting and pruritus	All patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences.	after the procedure, during the first 24 hours

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Basak Ceyda Meco, Ankara University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: morphine; vomiting; postoperative analgesia; Spinal anaesthesia
• Additional Relevant MeSH Terms: Skin Diseases; Signs and Symptoms, Digestive; Pathological Conditions, Anatomical; Hernia, Abdominal; Skin Manifestations; Vomiting; Hernia; Hernia, Inguinal; Pruritus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 11-02-09