Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor

• Sponsor: Indonesia University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05572775
• Collaborator: (none)
• Enrollment: 130
• Anticipated Duration (Months): 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Post Operative Pain; Kidney Transplant; Complications; Anesthesia Regional; Laparoscopy	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 Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• 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
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Chronic post-surgical pain [3 months after surgery]

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

Secondary Outcome Measures

1. The incidence of chronic post-surgical pain [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raden Besthadi Sukmono, Anesthesiologist, Indonesia University
• ClinicalTrials.gov Identifier: NCT05572775
• Other Study ID Numbers: Chronic Post-op Pain Donor
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 14, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain; Pain, Postoperative

Study Results

No Results Posted as of Oct 14, 2022