The Addition of Hydromorphone to Local Anesthetics for the Repair of Inguinal Hernias in Elderly Patients

January 11, 2024 updated by: Second Hospital of Jilin University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Second Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydromorphone combined with ropivacaine
The posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml.
Drug: Hydromorphone combined with ropivacaine
1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block
Other Names:
  • Quadratus lumbois block
Active Comparator: ropivacaine
A mixture of 0.375% ropivacaine for a total of 30ml was performed for posterior quadrate block.
Drug: Ropivacaine
A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block
Other Names:
  • Quadratus lumbois block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the end of surgery until two days after surgery.
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.
From the start of anesthesia until two days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of postoperative adverse reactions.
Time Frame: The operation ended two days after surgery.
The rates of postoperative nausea, vomiting and dizziness were compared between the two groups.
The operation ended two days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Jilin University

Investigators

  • Study Director: Dan Tian, Second Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 25, 2023

Study Registration Dates

First Submitted

December 30, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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