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Completed

NCT Number: NCT05572775

Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadratus Lumborum (QL) Block

Procedure

bilateral anterior subcostal quadratus lumborum block

Erector Spinae Plane (ESP) Block

Procedure

bilateral erector spinae plane block

Primary outcomes

  1. Chronic post-surgical pain

    Time frame: 3 months after surgery

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

Secondary outcomes

  1. The incidence of chronic post-surgical pain

    Time frame: 3 months after surgery

    the incidence of patients with chronic post-surgical pain 3 months after surgery

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

    Time frame: 3 months after surgery

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

    Time frame: 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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