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

July 27, 2022 updated by: Bora Dinc, Akdeniz University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07070
        • Akdeniz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LLDN with ESPB
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.
Diagnostic test: NAS score
Participants will be recorded according to the NAS and W-BAS pain scores
Other Names:
  • W-BAS score
No Intervention: LLDN without ESPB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: in 24 hours
Pain scores between the two groups will be compared
in 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total consumption of analgesic drugs
Time Frame: in 24 hours
The total consumption of analgesic drugs between the two groups will be compared
in 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

November 27, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pain management in LLDN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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