Comparison of Erector Spinae Plane Block and Intravenous Analgesic in Nefrectomy

NCT ID: NCT04686890

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-03-10

Brief Summary

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The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions

Detailed Description

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Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group. All patients will premedicated. then esp will applied to one group before surgery at the preoperative care unit by the same anesthesiologist. The other group will receive intravenous tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is responsible of all pcas' in the hospital was recorded the variables of these patients in the service

Conditions

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Regional Anesthesia Morbidity Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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postoperative opiod (morphine) consumption

patient-controlled analgesia (15 minutes. lock time, 2 ml bolus= total 1 mg morphine intravenously, limited to maximum 4 bolus / per hour )

Group Type ACTIVE_COMPARATOR

erector spinea plane block administered preoperative open nephrectomy

Intervention Type PROCEDURE

erector spinae plane block applied in this group before open nephrectomy

intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg

Intervention Type PROCEDURE

intarvenous analgesic administered in this group for analgesia end of the open nephrectomy

peroperative continuous opioid (remifentanil) consumption

continuous remifentanil infusion was given during the whole procedure

Group Type ACTIVE_COMPARATOR

erector spinea plane block administered preoperative open nephrectomy

Intervention Type PROCEDURE

erector spinae plane block applied in this group before open nephrectomy

intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg

Intervention Type PROCEDURE

intarvenous analgesic administered in this group for analgesia end of the open nephrectomy

postoperative numerated rating scale

at the 1, 3, 6, 12 and 24 th hour postoperatively - numerated rating scale score was evaluated and recoded as 0= no pain (better), 10: unbearable pain (worse)

Group Type ACTIVE_COMPARATOR

erector spinea plane block administered preoperative open nephrectomy

Intervention Type PROCEDURE

erector spinae plane block applied in this group before open nephrectomy

intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg

Intervention Type PROCEDURE

intarvenous analgesic administered in this group for analgesia end of the open nephrectomy

Interventions

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erector spinea plane block administered preoperative open nephrectomy

erector spinae plane block applied in this group before open nephrectomy

Intervention Type PROCEDURE

intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg

intarvenous analgesic administered in this group for analgesia end of the open nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* undergoing elective nephrectomy

Exclusion Criteria

* heart disease
* pregnancy
* lung disease
* scoliosis
* bleeding disorder
* infection at the manipulation side
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra Arslan

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University Medical Faculty

Locations

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Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KIA 2020/96

Identifier Type: -

Identifier Source: org_study_id

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