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U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

Primary Purpose

Pain, Hernia, Umbilical

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacain
Bupivacaine
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Open umbilical hernia, Transversus abdominis plane block, Erector spinae plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair.
  2. Age range of 18-65 years.

Exclusion Criteria:

  1. patient refusal.
  2. Patients belonging to ASA grade III and grade IV.
  3. Extreme obesity (BMI >35).
  4. hepatic or renal insufficiency.
  5. preoperative cognitive dysfunction or communication disorder.
  6. allergy to amide-type local anaesthetics.
  7. back puncture site infection.
  8. Coagulation disorders, pregnancy, drug abusers.

Sites / Locations

  • Banha Faculity of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (T)

Group (E)

Arm Description

receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.

receive preoperative bilateral ultrasound-guided erector spinae plane block.

Outcomes

Primary Outcome Measures

total morphine consumption.
Amount of morphine used as rescue analgesia post-operatively.

Secondary Outcome Measures

Intraoperative fentanyl consumption
Intraoperative fentanyl dosage (μg)
time of first analgesic request
first time of analgesia used after operation.
pain severity evaluation.
by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).

Full Information

First Posted
June 19, 2021
Last Updated
May 4, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04941170
Brief Title
U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia
Official Title
U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Pre-emptive Analgesia for Open Umbilical Hernia Repair; Randomized, Double-blinded Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen.
Detailed Description
TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique and decreases postoperative pain and opioid consumption. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. However, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) The present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral ESP block versus bilateral oblique subcostal TAP block on patients undergoing open umbilical hernia repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hernia, Umbilical
Keywords
Open umbilical hernia, Transversus abdominis plane block, Erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (T)
Arm Type
Active Comparator
Arm Description
receive preoperative bilateral ultrasound-guided oblique subcostal transversus abdominis plane block.
Arm Title
Group (E)
Arm Type
Active Comparator
Arm Description
receive preoperative bilateral ultrasound-guided erector spinae plane block.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
oblique subcostal transversus abdominis plane block
Intervention Description
Ultrasound-guided oblique subcostal transversus abdominis plane block will be performed in the supine position under strict aseptic precautions. placing a linear high-frequency ultrasound probe obliquely near the costal margin and xiphoid process On confirming the placement of the needle in the correct target space, 1 mL of 0.25% bupivacaine will be injected to hydro-dissect the fascia layer between the RA and TA. After confirming the separation of the transversus abdominis fascia plane, the remaining 19 mL of 0.25% bupivacaine will be administered, advancing the needle infero-laterally parallel to the subcostal margin. A similar procedure will be performed on the contralateral side of the abdomen with an injection of another 20 mL of 0.25% bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
erector spinae plane block
Intervention Description
Ultrasound-guided erector spinae plane block will be performed in the sitting position. T7 spinous process will be located To perform the block. The tip of the T7 transverse process will be then identified using the ultrasound probe that is placed in a transverse orientation The ultrasound transducer will then be placed in a longitudinal orientation 2-3 cm lateral to the midline in a longitudinal orientation to identify the hyperechoic line of the transverse process with its associated acoustic shadow. After local anaesthetic infiltration, the block needle will be inserted in a craniocaudal direction until contact will be achieved with the T 7 transverse process where the tip will lay in the inter-fascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle to confirm the proper needle position. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally.
Primary Outcome Measure Information:
Title
total morphine consumption.
Description
Amount of morphine used as rescue analgesia post-operatively.
Time Frame
in first 24 hours
Secondary Outcome Measure Information:
Title
Intraoperative fentanyl consumption
Description
Intraoperative fentanyl dosage (μg)
Time Frame
From the start of operation till its end up to 3 hours.
Title
time of first analgesic request
Description
first time of analgesia used after operation.
Time Frame
in 24 hours
Title
pain severity evaluation.
Description
by verbal numerical rating scale (VNRS) at rest and cough (0 = no pain, 10 = unbearable pain).
Time Frame
at PACU admission , 30 minutes , 2 hours , 4 hours , 8 hours ,12 hours ,18 hours and 24 hours post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair. Age range of 18-65 years. Exclusion Criteria: patient refusal. Patients belonging to ASA grade III and grade IV. Extreme obesity (BMI >35). hepatic or renal insufficiency. preoperative cognitive dysfunction or communication disorder. allergy to amide-type local anaesthetics. back puncture site infection. Coagulation disorders, pregnancy, drug abusers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatma ah abdelfatah, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha Faculity of Medicine
City
Banha
State/Province
Elqalyoubea
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

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U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

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