Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
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ClinicalTrials.gov Identifier: NCT05944523 |
Recruitment Status :
Completed
First Posted : July 13, 2023
Last Update Posted : July 13, 2023
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The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.
Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.
In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.
Condition or disease | Intervention/treatment | Phase |
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Erector Spina Plan Block Preemptive Analgesia Thoracotomy Nociception Level Index(NoL) | Procedure: Erector Spina Plan Block | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL) |
Actual Study Start Date : | January 1, 2022 |
Actual Primary Completion Date : | January 1, 2023 |
Actual Study Completion Date : | May 1, 2023 |
Arm | Intervention/treatment |
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Active Comparator: Group 1
The group in which preemptive erector spina plane block was applied
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Procedure: Erector Spina Plan Block
Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor. |
Active Comparator: Group 2
The group in which the end of the surgery was applied to the erector spina plane block
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Procedure: Erector Spina Plan Block
Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor. |
- The value of Nociception Level Index (NoL) in both preemptive and postoperative groups [ Time Frame: Up to 24 hours ]We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 18-65 years
- ASA classification <4
- No history of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI ≤ 35
- No history of neuropathy
- Surgeries other than emergency surgery
- Volunteer for the study
- No presence of infection at the injection site
- No any pyschiatric disease that would prevent the evaluation of the pain score
Exclusion Criteria:
- Under the age of 18 or over the age of 65
- ASA classification ≥ 4
- History of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI > 35
- History of neuropathy
- Undergoing emergency surgery
- Not be a volunteer for the study
- Presence of infection at the injection site
- Having a pyschiatric disease that would prevent the evaluation of the pain score
- Pregnancy
- Undergo surgery again during the postoperative follow-up period for any reason
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944523
Turkey | |
Faculty of Medicine, Ankara University | |
Ankara, Turkey, 06100 |
Study Director: | Neslihan Alkış, Prof. Dr. | Faculty of Medicine, Ankara University |
Responsible Party: | Canan Tokur, Research Assistant, Ankara University |
ClinicalTrials.gov Identifier: | NCT05944523 |
Other Study ID Numbers: |
CananT |
First Posted: | July 13, 2023 Key Record Dates |
Last Update Posted: | July 13, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
preemptive analgesia erector spina plan block nociception level (NoL) index thoracotomy opioid consumption |
Agnosia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |