Chronic Post Operative PainNCT05572775
Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor
An observational study of Chronic Post Operative Pain and Kidney Transplant; Complications, run by Universitas Indonesia at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Post Operative Pain, Kidney Transplant; Complications, Anesthesia Regional
- What is being tested?
- Quadratus lumborum (QL) block and Erector Spinae Plane (ESP) Block
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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
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
Read the 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
- Conditions
- Chronic Post Operative Pain, Kidney Transplant; Complications, Anesthesia Regional, Laparoscopy
- Being tested
- Quadratus lumborum (QL) block, Erector Spinae Plane (ESP) Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum (QL) blockProcedure or surgery
bilateral anterior subcostal quadratus lumborum block
Erector Spinae Plane (ESP) BlockProcedure or surgery
bilateral erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| Chronic post-surgical pain | Living kidney donor with the incidence of chronic post-surgical pain Receives: Procedure: Quadratus lumborum (QL) block; Procedure: Erector Spinae Plane (ESP) Block | |
| Non-Chronic Post-surgical pain | Living kidney donor without the incidence of chronic post-surgical pain Receives: Procedure: Quadratus lumborum (QL) block; Procedure: Erector Spinae Plane (ESP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain
the correlation between QL and ESP block technique and the incidence of chronic post-surgical pain
Measured: 3 months after surgery
Secondary outcomes (3)
The incidence of chronic post-surgical pain
the incidence of patients with chronic post-surgical pain 3 months after surgery
Measured: 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.
Measured: 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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jan 2023
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post Operative PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572775
- Sponsor's protocol ID
- Chronic Post-op Pain Donor
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05572775
- Acronym / sponsor ID
- Chronic Post-op Pain Donor
- Conditions
- Chronic Post Operative Pain, Kidney Transplant; Complications, Anesthesia Regional, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic post-surgical pain | – | Procedure: Quadratus lumborum (QL) block, Procedure: Erector Spinae Plane (ESP) BlockLiving kidney donor with the incidence of chronic post-surgical pain |
| Non-Chronic Post-surgical pain | – | Procedure: Quadratus lumborum (QL) block, Procedure: Erector Spinae Plane (ESP) BlockLiving kidney donor without the incidence of chronic post-surgical pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus lumborum (QL) blockbilateral anterior subcostal quadratus lumborum block | Procedure or surgery | Chronic post-surgical pain, Non-Chronic Post-surgical pain |
| Erector Spinae Plane (ESP) Blockbilateral erector spinae plane block | Procedure or surgery | Chronic post-surgical pain, Non-Chronic Post-surgical pain |
Primary outcome
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
3 secondary outcomes
The incidence of chronic post-surgical pain
Time frame: 3 months after surgery
The severity of chronic post-surgical pain Brief Pain Inventory (BPI)
Time frame: 3 months after surgery
Impact of chronic post-surgical pain on the daily activities (pain interferences)
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Post Operative Pain and Kidney Transplant; Complications, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic post-surgical pain (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.