Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial

• Sponsor: Kocaeli University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05913167
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

Nephrectomy pain was higher. Erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. The aim of this study was to compare the analgesic efficacy of these two bloc in laparoscopic nephrectomy patients. The primary aim is the postoperative morphine consumptions.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Nephrectomy	Procedure: laparoscopic nephrectomy	N/A

Detailed Description

Patients ASA 18-65 who will undergo laparoscopic nephrectomy included in this prospective randomized clinical trial. Patients will divide into two groups; erector spina and transversus abdominis plan bloc. Anesthesia will. induced with propofol and fentanyl and rocuronium will be admistered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: erector spina and tap blockserector spina and tap blocks
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants will not know which block was administered outcome assessors will not know which block was administered
• Primary Purpose: Diagnostic
• Official Title: Comparison of Erector Spina and Transversus Abdominus Plan Blocks
• Anticipated Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Jun 15, 2025
• Anticipated Study Completion Date: Jun 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: erector spina plan block erector spina plan block will be administered to the patients in this group.	Procedure: laparoscopic nephrectomy; laparoscopic nephrectomy
Active Comparator: transversus abdominis plan block transversus abdominis plan block will be administered to the patients in this group.	Procedure: laparoscopic nephrectomy; laparoscopic nephrectomy

Outcome Measures

Primary Outcome Measures

1. postoperative morphine consumption [24 hour postoperatively]

   morphine pca was applied to the patients

Secondary Outcome Measures

1. peroperative remifentanil consumptions [peroperatively]

   continious remifentanil infusion was applied

2. postoperative analgesia numeric rating scales [postoperative 24 hours]

   patients will give numbers to their pain first hour, 6th hour and 24 th hour after surgery

Eligibility Criteria

Criteria

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

Inclusion Criteria: 18-65 age patients undergoing laparoscopic nephrectomy

• ASA 1-3

Exclusion Criteria: <18- >65 < age patients undergoing open nephrectomy ASA 4-5

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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zehra Ipek ARSLAN, Professor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT05913167
• Other Study ID Numbers: LAPNEF2023
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• 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
• Keywords provided by Zehra Ipek ARSLAN, Professor, Kocaeli University: laparoscopy; nephrectomy; erector spina plan block; transversus abdominis plan block; morphine consumption; analgesia

Study Results

No Results Posted as of Jun 22, 2023