NCT05572775

Brief Summary

This study aimed to determine the relationship between the quadratus lumborum and erector spinae plane block technique and the incidence and severity of chronic post-surgical pain in accordance with Brief Pain Inventory Score (BPI) in retroperitoneal laparoscopic living kidney donor surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

September 26, 2022

Last Update Submit

September 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chronic post-surgical pain

    the correlation between QL and ESP block technique and the incidence of chronic post-surgical pain

    3 months after surgery

Secondary Outcomes (3)

  • The incidence of chronic post-surgical pain

    3 months after surgery

  • The severity of chronic post-surgical pain Brief Pain Inventory (BPI)

    3 months after surgery

  • Impact of chronic post-surgical pain on the daily activities (pain interferences)

    3 months after surgery

Study Arms (2)

Chronic post-surgical pain

Living kidney donor with the incidence of chronic post-surgical pain

Procedure: Quadratus lumborum (QL) blockProcedure: Erector Spinae Plane (ESP) Block

Non-Chronic Post-surgical pain

Living kidney donor without the incidence of chronic post-surgical pain

Procedure: Quadratus lumborum (QL) blockProcedure: Erector Spinae Plane (ESP) Block

Interventions

bilateral anterior subcostal quadratus lumborum block

Chronic post-surgical painNon-Chronic Post-surgical pain

bilateral erector spinae plane block

Chronic post-surgical painNon-Chronic Post-surgical pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target population is all living kidney donor patients with retroperitoneal laparoscopy technique and performed QL or ESP block technique at RSUPN Dr. Cipto Mangunkusumo

You may qualify if:

  • Patient 18-65 years old
  • Patient with ASA physical status assessment 1-3
  • All patient who have undergone living kidney donor with retroperitoneal laparoscopy at RSUPN Dr. Cipto Mangunkusumo (3 months postoperative)
  • The patient and/ or the family are willing to be interviewed about the patient's previous medical history and agree to be the subject of the study.

You may not qualify if:

  • Patient who have already known the cause of the chronic pain they had
  • Patient who have history of major surgery after the donor surgery
  • Patient died during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental OcclusionParapsychology

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaBehavioral SciencesBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 10, 2022

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations