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Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period

Primary Purpose

Pain, Postoperative, Donor Site Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NAS score
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring pain management, laparoscopic living-donor nephrectomy, erector spinae plane block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients aged 18-75 who were operated on under general anesthesia for LLDN surgery and agreed to participate in the study will be included.

Exclusion Criteria:

  • Participants who did not accept the study, had intraoperative complications, and whose laparoscopic operation was canceled will not be included in the study.

Sites / Locations

  • Akdeniz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

LLDN with ESPB

LLDN without ESPB

Arm Description

The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.

The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.

Outcomes

Primary Outcome Measures

Pain score
Pain scores between the two groups will be compared

Secondary Outcome Measures

The total consumption of analgesic drugs
The total consumption of analgesic drugs between the two groups will be compared

Full Information

First Posted
April 27, 2021
Last Updated
July 27, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04867070
Brief Title
Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period
Official Title
Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
November 27, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Laparoscopic living donor nephrectomy (LLDN) is a safe procedure and rapid wound healing, affecting the quality of life. The physiology of postoperative pain after LLDN has been attributed to reasons such as tissue damage, residual pneumoperitoneum, and diaphragm irritation. In terms of patient comfort after LLDN, pain control is provided by IV analgesics, local anesthetic injection instead of incision, and regional techniques. Regional anesthesia techniques for postoperative pain control have become popular in recent years. Today, many blocks are performed with ultrasonography (USG) to reduce the severity of pain after laparoscopic and open surgeries. In 2016, Forero et al. erector spinae plane block (ESPB) had been defined and used successfully in thoracic and abdominal surgeries. In our clinic, peripheral nerve blocks such as intravenous patient-controlled analgesia (PCA) and ESPB are applied for postoperative analgesia. The method of analgesia is suitable for the surgery and explained to the patients. This study; In LLDN operations, it was aimed to compare the bilateral ESP block performed with USG in terms of postoperative pain scores and opioid analgesic consumption compared to patients without any block. Before the operation, the anesthesiologist in charge of the anesthesia outpatient clinic provides information about both anesthesia and postoperative pain management methods suitable for surgery. This is the standard practice in our clinic. Before anesthesia, anesthesia and analgesia methods will be briefly reminded to the patient who has come for the operation. He/she will be asked if he/she wants to apply postoperative analgesia. Block procedure will be applied to patients who want ESP block. Standard analgesia will be applied to all patients. Regardless of the study, patients who underwent LLDN operation will be interviewed in the postoperative period with or without an ESP block for postoperative analgesia. The data and postoperative evaluations of the patients who agreed to participate in the study will be recorded for study purposes. The patient data will be taken from the hospital registration system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Donor Site Complication
Keywords
pain management, laparoscopic living-donor nephrectomy, erector spinae plane block

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After the application of the ESPB was explained to the volunteers, a block was applied if the patients provided their consent. The donors were randomly assigned to Group B (ESPB group) or Group C (control group) using computer-generated random numbers placed in separate closed envelopes that the study investigator opened before performing the block in the operation room.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LLDN with ESPB
Arm Type
Active Comparator
Arm Description
The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.
Arm Title
LLDN without ESPB
Arm Type
No Intervention
Arm Description
The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.
Intervention Type
Diagnostic Test
Intervention Name(s)
NAS score
Other Intervention Name(s)
W-BAS score
Intervention Description
Participants will be recorded according to the NAS and W-BAS pain scores
Primary Outcome Measure Information:
Title
Pain score
Description
Pain scores between the two groups will be compared
Time Frame
in 24 hours
Secondary Outcome Measure Information:
Title
The total consumption of analgesic drugs
Description
The total consumption of analgesic drugs between the two groups will be compared
Time Frame
in 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients aged 18-75 who were operated on under general anesthesia for LLDN surgery and agreed to participate in the study will be included. Exclusion Criteria: Participants who did not accept the study, had intraoperative complications, and whose laparoscopic operation was canceled will not be included in the study.
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22902793
Citation
Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.
Results Reference
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PubMed Identifier
29883965
Citation
Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.
Results Reference
background
PubMed Identifier
32979028
Citation
Daghmouri MA, Akremi S, Chaouch MA, Mesbahi M, Amouri N, Jaoua H, Ben Fadhel K. Bilateral Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Pract. 2021 Mar;21(3):357-365. doi: 10.1111/papr.12953. Epub 2020 Oct 25.
Results Reference
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Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period

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