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Intrathecal Morphine for Inguinal Hernia Repair.

Primary Purpose

Inguinal Hernia, Nausea, Vomiting

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg

intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg

standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

intravenous cannulation and premedication

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Spinal anaesthesia, morphine, postoperative analgesia, vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intrathecal morphine 0.1 mg

0.4 mg of intrathecal morphine

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02001948

First Posted

November 22, 2013

Last Updated

November 29, 2013

Sponsor

Ankara University

1. Study Identification

Unique Protocol Identification Number

NCT02001948

Brief Title

Intrathecal Morphine for Inguinal Hernia Repair.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia, Nausea, Vomiting, Pruritus, Postoperative Pain

Keywords

Spinal anaesthesia, morphine, postoperative analgesia, vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intrathecal morphine 0.1 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.4 mg of intrathecal morphine

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg

Intervention Type

Drug

Intervention Name(s)

intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg

Intervention Type

Device

Intervention Name(s)

standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland

Intervention Description

electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure

Intervention Type

Drug

Intervention Name(s)

intravenous cannulation and premedication

Intervention Description

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

Primary Outcome Measure Information:

Title

Sensory and motor block

Description

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.

Secondary Outcome Measure Information:

Title

first mobilisation, first urination and first analgesic times

Description

all patients will be followed up during the first postoperative 24 hours to assess the first mobilisation, first voiding and first analgesic requirement times.

Time Frame

after the procedure, during the first 24 hours

Other Pre-specified Outcome Measures:

Title

postoperative nausea, vomiting and pruritus

Description

All patients will be followed up for the first postoperative 24 hours to determine the nausea, vomiting and pruritus incidences.

Time Frame

after the procedure, during the first 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Basak Ceyda Meco

Organizational Affiliation

Ankara University Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Ankara

ZIP/Postal Code

06700

Country

Turkey

12. IPD Sharing Statement

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Intrathecal Morphine for Inguinal Hernia Repair.

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