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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03904082
Other study ID # 2019/175
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date January 1, 2020

Study information

Verified date April 2019
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.


Description:

Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 105
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

ASA I- ASA II Patients

Exclusion Criteria:

- history of allergy to the study medication

- refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spinae Plane block ( Group i)
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Serratus Anterior Plane block ( Group ii)
SAP Block will perform preoperative to all patients in SAP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Control Group (GROUPIII)
Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Locations

Country Name City State
Turkey Ayse Ülgey Kayseri Talas

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation

Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary opioid consumption In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours). 48 hours after surgery
Primary Verbal analog Pain Scores on rest and movement A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible. 48 hours after surgery
Secondary Incidences of adverse effects (like nausea and vomitting) Incidences of nausea and vomitting during the 48 hours postoperative period will recorded at 6 time intervals (2,4,6,12,24,48. hours) 48 hours after surgery
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