An observational study in Postoperative Pain and Breast Cancer, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by TC Erciyes University · Observational
Erector spinae plane block(ESPB), which is firstly used for thoracic neuropathic pain, is newly developed and highly promising fascial plane block for providing postoperative analgesia for a great deal of surgeries including breast surgery. The investigators aim to study efficacy of ESPB for patients who undergone breast cancer surgery and is expected to benefit from opioid-sparing effect of this technique.
This is a retrospective, single-center clinical trial to evaluate analgesic efficacy of Erector spinae plane block (ESPB) after breast cancer surgery. Participant's demographics and medical history, type and extent of surgery, systemic opioid and non-opioid analgesic consumptions, hemodynamic variables and adverse events during and first 24 hours after surgery. After operation, pain scores at first 24 hours, 1., 3., and 6. month will be obtanied from surgical ward and pain clinic registires. patient controlled analgesia device usage history will be obtained from device database at our clinic.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 40 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.
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all patients undergoing breast surgery for breast cancer between September 2018 and December 2019 were included in our study.
Exclusion Criteria:
patients who are administered ultrasound guided ESPB at T4 vertebrae level with long acting local anesthetic (%0,25 bupivacaine) and followed up with patient controlled analgesia device and all records about aforementioned data is completely available.
Procedure: Ultrasound guided Erector Spinae Plane Block (ESPB)
patients who are not administered any regional analgesic technique and followed up with patient controlled analgesia device and all records about aforementioned data is completely available.
Ultrasound guided ESPB is applied at T4 vertebrae level, 3 cm lateral to mid-line where transverse process lies. After identification of transverse process, needle is advanced in plane and real time visualisation on ultrasound screen. When bonny contact is encountered, normal saline is injected for verification of placement, then, 25 ml %0,25 bupivacaine is injected plane between transverse process and erector spinae muscles.
Opioid Consumption
all patients were given 0.05 mg/kg morphine iv and 1 gr paracetamol 30 minutes before end of surgery and in the recovery room, 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. Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Time frame: First 24 hours after surgery
Verbal Analog Pain Scores on rest and movement
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.
Time frame: First 24 hours after surgery, at 1., 3., 6. month
Demographic Data
Age, sex, medical history, BMI, ASA (American Society of Anesthesiologists) status, Duration and type of surgery were recorded
Time frame: First 24 hours after surgery
Blood Pressures
systolic, diastolic and mean arterial blood pressures as mmHg
Time frame: during and first 24 hours after surgery
Heart Rate
Heart rate as beat per minute (BPM)
Time frame: during and first 24 hours after surgery
incidence of adverse effects (like nausea and vomiting)
incidence of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours)
Time frame: First 24 hours after surgery
Rescue analgesic requirement
number of request and dosages of non opioid analgesics used for VAS equal or greater than 5 or patient request.
Time frame: First 24 hours after surgery
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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TC Erciyes University