Inguinal HerniaPhase 4NCT02001948
Intrathecal Morphine for Inguinal Hernia Repair.
A Phase 4 study testing 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 and standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland in people with Inguinal Hernia and Nausea, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia, Nausea, Vomiting
- What is being tested?
- 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 and standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiology physical status I-II patients
- aged 18-65 years
- undergoing elective unilateral open inguinal hernia repair surgery
Who cannot join
- contraindications to spinal anesthesia
- central or peripheral neuropathies
- severe respiratory or cardiac diseases
- chronic analgesic use
- history of substance abuse
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Ibni Sina Hospital general surgery OR
Ankara, 06700
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia, Nausea, Vomiting, Pruritus, Postoperative Pain
- Being tested
- 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
- Keywords
- Spinal anaesthesia, morphine, postoperative analgesia, vomiting
- Medical subject headings
- Hernia, Inguinal, Nausea, Vomiting, Pruritus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mgDrug
intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mgDrug
standard monitoring with Datex Ohmeda anesthesia monitor, GE, FinlandDevice
electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure
intravenous cannulation and premedicationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| intrathecal morphine 0.1 mg | Active comparator | 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 Receives: 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 |
| 0.4 mg of intrathecal morphine | Active comparator | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: after the procedure, during the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Ceyda MECO, Ankara University
- Investigators
- Basak Ceyda Meco, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001948
- Sponsor's protocol ID
- 11-02-09
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Two Different Doses of Morphine Added to Spinal Bupivacaine for Inguinal Hernia Repair.
- ClinicalTrials.gov ID
- NCT02001948
- Acronym / sponsor ID
- 11-02-09
- Conditions
- Inguinal Hernia, Nausea, Vomiting, Pruritus, Postoperative Pain
- Keywords
- Spinal anaesthesia, morphine, postoperative analgesia, vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal morphine 0.1 mg | Active comparator | 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 premedicationAfter 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 |
| 0.4 mg of intrathecal morphine | Active comparator | 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 premedicationAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiology physical status I-II patients
- aged 18-65 years
- undergoing elective unilateral open inguinal hernia repair surgery
Key exclusion criteria (6 listed)
- contraindications to spinal anesthesia
- central or peripheral neuropathies
- severe respiratory or cardiac diseases
- chronic analgesic use
- history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg | Drug | intrathecal morphine 0.1 mg |
| intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg | Drug | 0.4 mg of intrathecal morphine |
| standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finlandelectrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure | Device | 0.4 mg of intrathecal morphine, intrathecal morphine 0.1 mg |
| intravenous cannulation and premedication18-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 | 0.4 mg of intrathecal morphine, intrathecal morphine 0.1 mg |
Primary outcome
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.
1 secondary outcome
first mobilisation, first urination and first analgesic times
Time frame: after the procedure, during the first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Ceyda Meco principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 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 and standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland in people with Inguinal Hernia and Nausea, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013; AzTrials last refreshed its copy on 28 Oct 2026.