Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572775
• Other study ID #: Chronic Post-op Pain Donor
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Kidney Transplant; Complications
• Laparoscopy
• Pain, Postoperative

Intervention

Procedure:
• Quadratus lumborum (QL) block
bilateral anterior subcostal quadratus lumborum block
• Erector Spinae Plane (ESP) Block
bilateral erector spinae plane block

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of chronic post-surgical pain	the incidence of patients with chronic post-surgical pain 3 months after surgery	3 months after surgery
Secondary	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
Secondary	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