Back to resultsBilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
Primary Purpose
Postoperative Pain, Breast Hypertrophy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spinae plane block
sham block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery
Exclusion Criteria:
- Coagulopathy
- Allergy to amide-type local anesthetics
- Infection at the ESP block injection site
- Severe obesity (BMI > 35 kg/m2)
- Liver or renal deficiency
- Patients with anatomical deformities
- Recent use of analgesic drugs
- Patient refusal or inability to consent
Sites / Locations
- Cukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
ESP block group
sham block
Arm Description
The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied. Intervention: Sham block Other: Standard Pain Followup and Monitorization
Outcomes
Primary Outcome Measures
Postoperative morphine consumption
Morphine consumption in Patient Controlled Analgesia device
Secondary Outcome Measures
Intraoperative anesthetic consumption
Intraoperative total doses of remifentanil, pentothal, desflurane consumption
Extubation and recovery time
Using modified aldrete score
Pain assessed by NRS
Numeric rating scale (NRS) at rest and in motion will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Degree of sedation
Ramsay Sedation Scale (RSS) will be used to assess degree of sedation. The RSS was designed as a test of arousability. The RSS scores sedation at six different levels, according to how arousable the patient is. The RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive.
Rate of opioid related side effects
Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.
Supplemental and rescue analgesic requirement
Total supplemental and rescue analgesic consumption
Patient satisfaction assessment
It will be assessed with patient satisfaction scale classified as 'excellent': no pain, NRS=0; 'good': very mild pain, NRS=1-2; 'moderate': mild pain, NRS=3-4.
Bilateral shoulder mobility
It will be assessed with ability of shoulder abduction degree
Length of stay in hospital
Duration of length of stay in hospital will be recorded
Rate of block related complications
Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03621345
Brief Title
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
Official Title
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Breast Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESP block group
Arm Type
Active Comparator
Arm Description
The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain.
Interventions:
Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
Arm Title
sham block
Arm Type
Sham Comparator
Arm Description
A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied.
Intervention: Sham block Other: Standard Pain Followup and Monitorization
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.
Intervention Type
Other
Intervention Name(s)
sham block
Intervention Description
A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Morphine consumption in Patient Controlled Analgesia device
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intraoperative anesthetic consumption
Description
Intraoperative total doses of remifentanil, pentothal, desflurane consumption
Time Frame
During operation time
Title
Extubation and recovery time
Description
Using modified aldrete score
Time Frame
Through surgical operation completion
Title
Pain assessed by NRS
Description
Numeric rating scale (NRS) at rest and in motion will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
24 hours
Title
Degree of sedation
Description
Ramsay Sedation Scale (RSS) will be used to assess degree of sedation. The RSS was designed as a test of arousability. The RSS scores sedation at six different levels, according to how arousable the patient is. The RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive.
Time Frame
24 hours
Title
Rate of opioid related side effects
Description
Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.
Time Frame
24 hours
Title
Supplemental and rescue analgesic requirement
Description
Total supplemental and rescue analgesic consumption
Time Frame
24 hours
Title
Patient satisfaction assessment
Description
It will be assessed with patient satisfaction scale classified as 'excellent': no pain, NRS=0; 'good': very mild pain, NRS=1-2; 'moderate': mild pain, NRS=3-4.
Time Frame
At the postoperative 24th hour
Title
Bilateral shoulder mobility
Description
It will be assessed with ability of shoulder abduction degree
Time Frame
Preoperative and postoperative 4th, 8th, 12th, and 24th hours
Title
Length of stay in hospital
Description
Duration of length of stay in hospital will be recorded
Time Frame
Until discharge from hospital, up to 7 days postoperatively
Title
Rate of block related complications
Description
Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded.
Time Frame
Until discharge from hospital, up to 7 days postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery
Exclusion Criteria:
Coagulopathy
Allergy to amide-type local anesthetics
Infection at the ESP block injection site
Severe obesity (BMI > 35 kg/m2)
Liver or renal deficiency
Patients with anatomical deformities
Recent use of analgesic drugs
Patient refusal or inability to consent
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sariçam
ZIP/Postal Code
01100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
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