Inguinal HerniaNCT06218160
The Addition of Hydromorphone to Local Anesthetics for the Repair of Inguinal Hernias in Elderly Patients
A study testing Hydromorphone combined with ropivacaine and Ropivacaine in people with Inguinal Hernia, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Hydromorphone combined with ropivacaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 25 Dec 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and above.
- Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to 3.
- No recent use of sedatives, opioids, or other analgesics.
- Good compliance, signed informed consent.
- Complete clinical data.
Who cannot join
- There are serious cardiovascular and cerebrovascular diseases.
- Abdominal infection.
- Coagulation dysfunction or receiving anticoagulation therapy.
- Local anesthesia drug allergy.
- Can not cooperate with the corresponding operation, suffering from mental illness.
- Previous surgical history of the corresponding position in the abdomen that may interfere with the surgical process of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Ropivacaine Combined With Hydromorphone to Block Lumbar Muscle in Elderly Inguinal Hernia Repair.
To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.
Read the detailed description
Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.
- Conditions
- Inguinal Hernia
- Being tested
- Hydromorphone combined with ropivacaine, Ropivacaine
- Keywords
- hydromorphone, Quadratus lumbois block, old people
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone combined with ropivacaineDrug
Also called Quadratus lumbois block
1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block
RopivacaineDrug
Also called Quadratus lumbois block
A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block
| Study group | Role | What they receive |
|---|---|---|
| Hydromorphone combined with ropivacaine | Experimental | The posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml. Receives: Drug: Hydromorphone combined with ropivacaine |
| ropivacaine | Active comparator | A mixture of 0.375% ropivacaine for a total of 30ml was performed for posterior quadrate block. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.
Visual analogue scale (VAS) was used to score the postoperative pain at 6,12,18,24,48h.The score ranges from 0 (no pain) to 10 (most severe pain). The change was equal to the score difference between the two groups at different observation time points (6,12,18,24,48h).
Measured: From the end of surgery until two days after surgery.
Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.
The range of the effective time of anesthesia minus the start time of anesthesia and the maintenance time minus the start time of anesthesia are respectively.The unit of time is minutes.
Measured: From the start of anesthesia until two days after surgery.
Secondary outcomes (1)
The occurrence of postoperative adverse reactions.
The rates of postoperative nausea, vomiting and dizziness were compared between the two groups.
Measured: The operation ended two days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Nov 2022
- Primary completion30 Nov 2023
- Study completion25 Dec 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Tian, Study director, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218160
- Sponsor's protocol ID
- 2022/148
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Ropivacaine Combined With Hydromorphone to Block Lumbar Muscle in Elderly Inguinal Hernia Repair.
- ClinicalTrials.gov ID
- NCT06218160
- Acronym / sponsor ID
- 2022/148
- Conditions
- Inguinal Hernia
- Keywords
- hydromorphone, Quadratus lumbois block, old people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- 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.
To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.
Detailed description
Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydromorphone combined with ropivacaine | Experimental | Drug: Hydromorphone combined with ropivacaineThe posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml. |
| ropivacaine | Active comparator | Drug: RopivacaineA mixture of 0.375% ropivacaine for a total of 30ml was performed for posterior quadrate block. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 and above.
- Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to 3.
- No recent use of sedatives, opioids, or other analgesics.
- Good compliance, signed informed consent.
- Complete clinical data.
Key exclusion criteria (6 listed)
- There are serious cardiovascular and cerebrovascular diseases.
- Abdominal infection.
- Coagulation dysfunction or receiving anticoagulation therapy.
- Local anesthesia drug allergy.
- Can not cooperate with the corresponding operation, suffering from mental illness.
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 |
|---|---|---|
| Hydromorphone combined with ropivacaineAlso: Quadratus lumbois block1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block | Drug | Hydromorphone combined with ropivacaine |
| RopivacaineAlso: Quadratus lumbois blockA mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block | Drug | ropivacaine |
Primary outcome
Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.
Time frame: From the end of surgery until two days after surgery.
Visual analogue scale (VAS) was used to score the postoperative pain at 6,12,18,24,48h.The score ranges from 0 (no pain) to 10 (most severe pain). The change was equal to the score difference between the two groups at different observation time points (6,12,18,24,48h).
Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.
Time frame: From the start of anesthesia until two days after surgery.
The range of the effective time of anesthesia minus the start time of anesthesia and the maintenance time minus the start time of anesthesia are respectively.The unit of time is minutes.
1 secondary outcome
The occurrence of postoperative adverse reactions.
Time frame: The operation ended two days after surgery.
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 23 Jan 2024.
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Dan Tian study director
Second Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydromorphone combined with ropivacaine and Ropivacaine in people with Inguinal Hernia, run by Second Hospital of Jilin University at 1 site in China.
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 5 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 23 Jan 2024. 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 China. 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.
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?
Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery. (time frame: From the end of surgery until two days after surgery.). The study lists 2 primary outcomes in all. 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 23 Jan 2024.