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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06218160
Other study ID # 2022/148
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 25, 2023

Study information

Verified date January 2024
Source Second Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 25, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydromorphone combined with ropivacaine
1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block
Ropivacaine
A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block

Locations

Country Name City State
China Second Hospital of Jilin University Changchun Jilin

Sponsors (1)

Lead Sponsor Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). From the end of surgery until two days after surgery.
Primary 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. From the start of anesthesia until two days after surgery.
Secondary The occurrence of postoperative adverse reactions. The rates of postoperative nausea, vomiting and dizziness were compared between the two groups. The operation ended two days after surgery.
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