Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study

• Sponsor: Kocaeli University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05810571
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 13.1
• Patients Per Site: 30
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Procedure: preoperative remifentanil consumption; Procedure: postopeartive controlled anlagesia with morphine	N/A

Detailed Description

patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continious remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: participant will not know which block applied, and the outcome assessor of the postoperative analgesia will not know
• Primary Purpose: Diagnostic
• Official Title: Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jan 3, 2024
• Anticipated Study Completion Date: Apr 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: patient controlled analgesia this group of patients received no block, received only postoperative patient-controlled analgesia with morphine	Procedure: preoperative remifentanil consumption; continuous remifentanil infusion will applied for peroperative analgesia; Procedure: postopeartive controlled anlagesia with morphine; postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
Active Comparator: erector spina plane block this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine	Procedure: preoperative remifentanil consumption; continuous remifentanil infusion will applied for peroperative analgesia; Procedure: postopeartive controlled anlagesia with morphine; postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
Active Comparator: quadratus lumborum block this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine	Procedure: preoperative remifentanil consumption; continuous remifentanil infusion will applied for peroperative analgesia; Procedure: postopeartive controlled anlagesia with morphine; postoperative morphine patient controlled analgesia will be applied for postoperative analgesia

Outcome Measures

Primary Outcome Measures

1. postoperative morphine consumption [24 hour postoperatively]

   amount of postoperative morphine use of the patient's

Secondary Outcome Measures

1. peroperative remifentanil consumptions [4 hour preoperatively]

   amount of remifentanil use of the patient's

2. numeric rating scale [24 hour postoperatively]

   numeric rating scores of the patient's postoepartively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA 1-3

• open nephrectomy elective patients

• BMI<35

Exclusion Criteria:

• ASA 4-5-6

• Laparoscopic nephrectomy

• infection at the block side

• coagulation disorder

• BMI>35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University School of Medicine	Kocaeli		Turkey	41900
2	Kocaeli University Medical Faculty	Kocaeli		Turkey

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: NCT05810571
• Other Study ID Numbers: KAEK / 12bl.01
• First Posted: Apr 12, 2023
• Last Update Posted: Apr 12, 2023
• Last Verified: Mar 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: erector spina plane block; quadratus lumborum block; patient controlled analgesia; nephrectomy; analgesia
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Morphine; Remifentanil

Study Results

No Results Posted as of Apr 12, 2023