NCT06218160

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 30, 2023

Last Update Submit

January 11, 2024

Conditions

Inguinal Hernia

Keywords

hydromorphoneQuadratus lumbois blockold people

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • The occurrence of postoperative adverse reactions.

    The operation ended two days after surgery.

Study Arms (2)

Hydromorphone combined with ropivacaine

EXPERIMENTAL

The posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml.

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.

Drug: Ropivacaine

Interventions

Hydromorphone combined with ropivacaineDRUG

1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block

Also known as: Quadratus lumbois block
Hydromorphone combined with ropivacaine
RopivacaineDRUG

A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block

Also known as: Quadratus lumbois block
ropivacaine

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dan Tian

    Second Hospital of Jilin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 23, 2024

Study Start

November 1, 2022

Primary Completion

November 30, 2023

Study Completion

December 25, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

CN(1)