Comparison of Erector Spinae Plane Block and Rectus Sheath Block
Primary Purpose
Postoperative Pain, Acute
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bupivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain, Acute focused on measuring erector spinae plane block, rectus sheath block, pain management, midline laparotomy
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) classes I-III
Exclusion Criteria:
- Local anesthetic allergy
- Coagulopathy
- Injection site infection
- History of abdominal surgery
- Severe neurological or psychiatric disorder
- Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
- chronic opioid use
Sites / Locations
- Bursa Uludag University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group ESPB
Group RSB
Arm Description
Erector spinae plane block
Rectus sheath block
Outcomes
Primary Outcome Measures
intraoperative hemodynamic data and administered opioid doses
Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
postoperative visual analog scales at rest and during coughing
Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
time to first patient controlled analgesia (PCA) dose
The times when patients used the PCA device for the first time were recorded and compared between groups.
postoperative morphine consumption
Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
need for rescue analgesics
Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
duration time until first mobilization
The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
opioid side effects
Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
patient and surgeon satisfaction
Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05225766
Brief Title
Comparison of Erector Spinae Plane Block and Rectus Sheath Block
Official Title
Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.
Detailed Description
Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
Keywords
erector spinae plane block, rectus sheath block, pain management, midline laparotomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group ESPB
Arm Type
Active Comparator
Arm Description
Erector spinae plane block
Arm Title
Group RSB
Arm Type
Active Comparator
Arm Description
Rectus sheath block
Intervention Type
Other
Intervention Name(s)
bupivacaine
Intervention Description
used for peripheral block
Primary Outcome Measure Information:
Title
intraoperative hemodynamic data and administered opioid doses
Description
Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
Time Frame
150 minutes
Title
postoperative visual analog scales at rest and during coughing
Description
Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
Time Frame
48 hours
Title
time to first patient controlled analgesia (PCA) dose
Description
The times when patients used the PCA device for the first time were recorded and compared between groups.
Time Frame
48 hours
Title
postoperative morphine consumption
Description
Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
Time Frame
48 hours
Title
need for rescue analgesics
Description
Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
Time Frame
48 hours
Title
duration time until first mobilization
Description
The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
Time Frame
48 hours
Title
opioid side effects
Description
Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
Time Frame
48 hours
Title
patient and surgeon satisfaction
Description
Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-75 years
American Society of Anesthesiologists (ASA) classes I-III
Exclusion Criteria:
Local anesthetic allergy
Coagulopathy
Injection site infection
History of abdominal surgery
Severe neurological or psychiatric disorder
Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
chronic opioid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre SALMAN, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa Uludag University
City
Bursa
State/Province
Nilüfer
ZIP/Postal Code
16059
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Erector Spinae Plane Block and Rectus Sheath Block
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