Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy (Erector Spinae)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
control
Sponsored by

About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring Erector Spinae Plane Block, Postoperative Analgesia, Total Abdominal Hysterectomy, fentanyl consumption
Eligibility Criteria
Inclusion Criteria:
- female patients
- Aged 40 - 70 years,
- Weighted 50 - 90 Kg
- American society of Anesthesiologists physical status (ASA) class Ι to ΙΙΙ
- Scheduled for elective total abdominal hysterectomy under general anesthesia
Exclusion Criteria:
- Local infection at the site of puncture
- Patients having a history of hematological disorders, including coagulation abnormality
- Patients with severe hepatic impairment
- Patients with chronic pain
- A patient had a known allergy to study drugs.
Sites / Locations
- Mohamed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ES
control
Arm Description
Erector Spinae Plane Block
the control group will not receive block
Outcomes
Primary Outcome Measures
Fentanyl consumption
in microgram
Secondary Outcome Measures
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Visual analog score
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03741348
Brief Title
Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Acronym
Erector Spinae
Official Title
Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to assess the efficacy of bilateral ESPB on postoperative analgesia in patients undergoing total abdominal hysterectomy under general anesthesia.
Detailed Description
60 patients Scheduled for elective total abdominal hysterectomy, after obtaining a written informed consent for anesthesia from each patient before enrolment in the study after explaining to them the nature of study.
Inclusion criteria included female patients aged 40 - 70 years, Weighted 50 - 90 Kg and with American society of anesthesiologists physical status (ASA) class Ι to ΙΙΙ Scheduled for elective total abdominal hysterectomy under general anesthesia. Exclusion criteria included Local infection at the site of puncture, Patients having history of hematological disorders, including coagulation abnormality, Patients with severe hepatic impairment, Patients with chronic pain and Patient had a known allergy to study drugs.
Patients were randomized into two equal groups. An online randomization program was used to generate random number list. Patient randomization numbers were concealed in opaque envelops which were opened by the study investigator.
Members of the study group involved in obtaining functional data were blinded to randomization for the period of data acquisition and analysis. Patients were randomly allocated into two groups:
Erector spinae plane block Group (ES): ultrasound guided erector spinae plane block at T9 vertebrae level with 20 ml of bupivacaine 0. 5%. Control Group (c): did not receive block.
One day before surgery all patients were interviewed to explain visual analogue scale (VAS), learned how to use patient controlled analgesia (PCA) pump and routine investigations were fulfilled.
In both groups Patients were monitored with ECG, non-invasive blood pressure monitoring and pulse oximetry. IV access was established and IV midazolam 0.01-0.02 mg.kg-1 was given.
In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back: the trapezius muscle above, the rhomboid major muscle in the middle and the erector-spinae muscle on the bottom, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22-gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Correct needle placement was confirmed by Visualizing the needle in plane along its entire length, when it contacted the transverse process, 1 ml of anesthetic solution was injected. Hydrodissection of the interfascial plane between the erector spinae muscle and the transverse process was confirmed by visualizing the local anesthetic spreading in a linear pattern between the muscle and the bony acoustic shadows of the transverse process, ensuring correct localization. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back. Control Group (c): the same pervious technique as in ES group but patient did not receive block.
Block success was tested by reduced cold sensation at planned surgical incision 5 minutes after block completion.
General anesthesia was induced with fentanyl 2 mcg.kg-1, propofol 2 mg.kg-1 followed by atracium 0.5 mg.kg-1 and after intubation Anesthesia was maintained with isoflurane (1 MAC) and atracium 0.1mg.kg-1 as a maintenance dose every 30 minutes till the end of the procedure; After emerging from anesthesia, the patients were transferred to the post aesthesia care unit (PACU) for a 2 hours observation period. The patients were discharged from the PACU after fulfilling the discharge criteria based on Aldrete score. Postoperative analgesia was provided in both groups immediately after surgery by PCA fentanyl pump then regular oral acetaminophen 1 g four times a day.
The criteria to stop fentanyl titration protocol were satisfactory pain control, Patient became sedated (Ramsay sedation scale >2), Respiratory rate < 12 / min, Oxygen saturation < 95% or development of serious adverse effects (allergy, severe vomiting, hypotension).
Visual analogue pain score (VAS) for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) was measured postoperatively at 30 min and 2, 4, 6, 12, and 24 hour postoperative.
Any side effects were recorded as nausea or vomiting, pneumothorax, or any other complications. Also Duration of hospital stays, from the first day postoperative until discharge.
The primary outcome of this study was Total fentanyl consumption in the first 24 hours And The secondary outcome was VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) was evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 hour postoperative, Duration of hospital stays and any complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Erector Spinae Plane Block, Postoperative Analgesia, Total Abdominal Hysterectomy, fentanyl consumption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ES
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
the control group will not receive block
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22-gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back.
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
in control group, Erector Spinae Plane Block will not be done
Primary Outcome Measure Information:
Title
Fentanyl consumption
Description
in microgram
Time Frame
first 24 hours postoperative
Secondary Outcome Measure Information:
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
30 minutes postoperative
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
2 hours postoperative
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
4 hours postoperative
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
6 hours postoperative
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
12 hours postoperative
Title
Visual analog score
Description
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Time Frame
24 hours postoperative
Other Pre-specified Outcome Measures:
Title
Age
Description
in years
Time Frame
4 hours before operation once recruited
Title
Weight
Description
in Kilogram
Time Frame
4 hours before operation once recruited
Title
Duration of surgery
Description
in minutes
Time Frame
4 minutes after end of operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients
Aged 40 - 70 years,
Weighted 50 - 90 Kg
American society of Anesthesiologists physical status (ASA) class Ι to ΙΙΙ
Scheduled for elective total abdominal hysterectomy under general anesthesia
Exclusion Criteria:
Local infection at the site of puncture
Patients having a history of hematological disorders, including coagulation abnormality
Patients with severe hepatic impairment
Patients with chronic pain
A patient had a known allergy to study drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed a hamed, MD
Organizational Affiliation
Fayoum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed
City
Fayoum
ZIP/Postal Code
65345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23945838
Citation
Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
Results Reference
background
PubMed Identifier
19020158
Citation
Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
Results Reference
background
PubMed Identifier
27997492
Citation
Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526. No abstract available.
Results Reference
background
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Erector Spinae Plane Block For Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
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