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出境医 / 临床实验 / Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

Transversus Abdominis Plane Block Versus Erector Spinae Plane Block

Study Description
Brief Summary:

The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP .

Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .


Condition or disease Intervention/treatment Phase
Postoperative Pain Laparotomy Procedure: transversus abdominis plane block Procedure: erector spinae plane block Other: control group Not Applicable

Detailed Description:

Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection.

Methods:

Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.
Actual Study Start Date : May 15, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 12, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Group I (A group)
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
Procedure: erector spinae plane block
The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Active Comparator: Group II (B group)
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
Procedure: transversus abdominis plane block
The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected

Placebo Comparator: Group III (C group)
31 patients anesthetized with the protocol followed by Minia University Hospital
Other: control group
placebo

Outcome Measures
Primary Outcome Measures :
  1. Time of First Post Operative Analgesic Request [ Time Frame: 24 hours ]
    the pain will be assisted based on the time for the first dose of rescue analgesia

  2. Postoperative Total Fentanyl Requirement [ Time Frame: 24 hours ]
    The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours


Secondary Outcome Measures :
  1. Incidence of Any Adverse Events [ Time Frame: 5 days ]
    adverse events related to technique or drugs


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

Exclusion Criteria:

  1. Drug allergy .
  2. Morbid obesity (BMI >40 kg/m2) .
  3. Psychiatric disorder .
  4. Opioid dependence .
  5. patient refuse
Contacts and Locations

Locations
Layout table for location information
Egypt
Minia University Hospital
Minya, Egypt, 61511
Sponsors and Collaborators
Hassan Mokhtar Elshorbagy Hetta
Investigators
Layout table for investigator information
Study Chair: Nagy S. Ali, MD Minia University Hospital
Study Director: Abeer A Hassanien Minia University Hospital
Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE June 18, 2019
Results First Submitted Date  ICMJE February 11, 2020
Results First Posted Date  ICMJE March 25, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE May 15, 2019
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Time of First Post Operative Analgesic Request [ Time Frame: 24 hours ]
    the pain will be assisted based on the time for the first dose of rescue analgesia
  • Postoperative Total Fentanyl Requirement [ Time Frame: 24 hours ]
    The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Time of First Post Operative Analgesic Request [ Time Frame: 24 hours ]
    the pain will be assisted based on the time for the first dose of rescue analgesia
  • Visual analogue scale [ Time Frame: 24 hours ]
    the pain will be assisted between (0-10) where 0=no pain and 10=worst pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
Incidence of Any Adverse Events [ Time Frame: 5 days ]
adverse events related to technique or drugs
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Incidence of any side effect [ Time Frame: 24 hours ]
complictions related to technique or drugs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane Block Versus Erector Spinae Plane Block
Official Title  ICMJE Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies.
Brief Summary

The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP .

Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .

Detailed Description

Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).

Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).

Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection.

Methods:

Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Postoperative Pain
  • Laparotomy
Intervention  ICMJE
  • Procedure: transversus abdominis plane block
    The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
  • Procedure: erector spinae plane block
    The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
  • Other: control group
    placebo
Study Arms  ICMJE
  • Experimental: Group I (A group)
    31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
    Intervention: Procedure: erector spinae plane block
  • Active Comparator: Group II (B group)
    31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
    Intervention: Procedure: transversus abdominis plane block
  • Placebo Comparator: Group III (C group)
    31 patients anesthetized with the protocol followed by Minia University Hospital
    Intervention: Other: control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
90
Actual Study Completion Date  ICMJE February 12, 2020
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age18-70 . 2. Both gender . 3 .Emergency laparotomies . 4. ASA I-III .

Exclusion Criteria:

  1. Drug allergy .
  2. Morbid obesity (BMI >40 kg/m2) .
  3. Psychiatric disorder .
  4. Opioid dependence .
  5. patient refuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989570
Other Study ID Numbers  ICMJE 73-7/2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hassan Mokhtar Elshorbagy Hetta, Minia University
Study Sponsor  ICMJE Hassan Mokhtar Elshorbagy Hetta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nagy S. Ali, MD Minia University Hospital
Study Director: Abeer A Hassanien Minia University Hospital
PRS Account Minia University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP