Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT03897933
Collaborator
(none)
60
1
13
4.6

Study Details

Study Description

Brief Summary

To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector Spinae Plane block ( Group I)
  • Procedure: non- blocked Group (GROUP II)

Detailed Description

Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Erector spinae plane block group (ESP)

Single- shot ultrasound guided ESP block with 30 ml 0.25% bupivacain at the T10 vertebral level was performed preoperatively to patients in the ESP group (Group I).

Procedure: Erector Spinae Plane block ( Group I)
ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

non- blocked Group

consists of the patient group without any procedure

Procedure: non- blocked Group (GROUP II)
This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Outcome Measures

Primary Outcome Measures

  1. opioid consumption [24 hours after surgery]

    In the recovery room, all patients were given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time and 10 mg 4 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

  2. Verbal analog Pain Scores on rest and movement [24 hours after surgery]

    A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

Secondary Outcome Measures

  1. Demographic data [24 hours after surgery]

    Age, BMI, ASA, Duration of surgery was recorded.

  2. incidences of adverse effects (like nausea and vomiting) [24 hours after surgery]

    incidences of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA I- ASA II Patients
Exclusion Criteria:
  • history of allergy to the study medication

  • refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sibel Seçkin Pehlivan Kayseri Talas Turkey 38039

Sponsors and Collaborators

  • TC Erciyes University

Investigators

  • Study Director: Sibel Pehlivan, TC Erciyes University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT03897933
Other Study ID Numbers:
  • 2019/881
First Posted:
Apr 1, 2019
Last Update Posted:
Aug 1, 2022
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022