Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor

Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor in Cipto Mangunkusumo Hospital: Comparison Analysis of Brief Pain Inventory (BPI) in Erector Spinae Plane (ESP) Block VS Quadratus Lumborum (QL) Block

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

Study Overview

• Status: Completed
• Conditions: Chronic Post Operative Pain; Laparoscopy; Kidney Transplant; Complications; Anesthesia Regional
• Intervention / Treatment: Procedure: Quadratus lumborum (QL) block; Procedure: Erector Spinae Plane (ESP) Block

Detailed Description

A minimum of 130 subjects will be recruited and divided into two groups (65 QL block, 65 ESP block). The researcher will use the Brief Pain Inventory (BPI) score to assess the incidence and severity of chronic pain of the living kidney donor who has undergone retroperitoneal laparoscopy with QL or ESP block technique

• Study Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic post-surgical pain; Living kidney donor with the incidence of chronic post-surgical pain	Procedure: Quadratus lumborum (QL) block; bilateral anterior subcostal quadratus lumborum block; Procedure: Erector Spinae Plane (ESP) Block; bilateral erector spinae plane block
Non-Chronic Post-surgical pain; Living kidney donor without the incidence of chronic post-surgical pain	Procedure: Quadratus lumborum (QL) block; bilateral anterior subcostal quadratus lumborum block; Procedure: Erector Spinae Plane (ESP) Block; bilateral erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of chronic post-surgical pain	the incidence of patients with chronic post-surgical pain 3 months after surgery	3 months after surgery
The severity of chronic post-surgical pain Brief Pain Inventory (BPI)	the severity of chronic post-surgical pain 3 months after surgery. Assessed in The Brief Pain Inventory (BPI) short version. Zero (0) represent no pain and Ten (10) represent pain as bad as you can imagine.	3 months after surgery
Impact of chronic post-surgical pain on the daily activities (pain interferences)	Impact of chronic post-surgical pain on daily activities (pain interferences). Assessed using The Brief Pain Inventory (BPI), described in 0 (zero) does not interfere and 10 (ten) completely interferes daily activities.	3 months after surgery

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: Chronic Post-op Pain Donor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No