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Lumbar Paravertebral in Hernia Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lumbar paravertebral group
The field block group
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients subjected to an elective unilateral inguinal hernia repair.
  2. American Society for Anesthesiologists physical status grades I and II.

Exclusion Criteria:

1. Parental refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, etc.) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at the site of the block. 6. Known intolerance to the study drugs.

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Sites / Locations

  • Mansoura University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lumbar paravertebral group

The field block group

Arm Description

After general anesthesia, the patient is placed prone. To establish the level of the block, we used US-counting of vertebrae. After determining the lumbar one level, the block performed at a parallel line 2 cm lateral to the spinous process, the transducer is moved until the corresponding transverse process is identified. Utilizing an in-plane approach from lateral to medial, a spinal needle is advanced until contact with the transverse process. The needle is withdrawn and redirected caudally under the transverse process helped by the loss of resistance technique. the solution is slowly injected after negative aspiration for blood.

The ilioinguinal nerve block was done at one fingerbreadth from the anterior superior iliac spine in a line with the pubic tubercle, The injection was done after the bob of the needle after passing the external oblique aponeurosis and muscle and 5ml of the solution is injected. The rest of the solution is injected in the incision line.

Outcomes

Primary Outcome Measures

The total dose of analgesics required in the post-operative periods
Fentanyl in microgram.

Secondary Outcome Measures

Modified Faces Legs Activity Cry Consolability Revised pain Scale
pain score of 5 items (Faces, Legs, Activity, Cry, Consolability) each of 0, 1, or 2 points. 0= express no pain, 1= mild pain, 2= the highest pain indicator. A total score 0 = Relaxed and comfortable. 1-3 = Mild discomfort. 4-6 = Moderate pain. 7-10 = Severe pain.
Mean Blood pressure
millimeter mercury
Heart rate
beat/minutes
Modified Ramsay sedation scale.
a scale from (1- 6), 1 = anxious; 2 = oriented & tranquil; 3 = sedated, but responds to commands; 4 = asleep, brisk glabellar reflex or response to loud noise; 5 = asleep, slugglish glabellar reflex or response to loud noise; 6 = asleep with no response to painful stimulus
Parents' satisfaction score
in a visual analogue score from (0-10), 0= minimal satisfaction, 10 = the highest satisfaction.
Adverse effects including nausea and vomiting, bradycardia (heart rate less than 60 beat/minute)
percent

Full Information

First Posted
January 10, 2018
Last Updated
January 30, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03408184
Brief Title
Lumbar Paravertebral in Hernia Surgery
Official Title
Comparison Between Lumbar Paravertebral and Field Blocks in Pediatric Inguinal Hernia Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 9, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura 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
An inguinal hernia is one of the most common disorders requiring surgical repair in pediatrics. The effective treatment of postoperative pain in infants and children is challenging. Although the use of opioid analgesics is generally safe, adverse effects occur frequently, so the use of alternative analgesic techniques when available to improve postoperative analgesia while limiting opioid-related adverse effects, that is why there is an increase in the use of regional anesthetic techniques in infants and children.
Detailed Description
Different anesthetic regional techniques can be used for anesthesia and analgesia of the lower abdominal surgeries such as caudal, spinal, epidural, transversus abdominis plane block, ilioinguinal nerve block, lumbar plexus block, the field block and abdominal paravertebral block. The use of regional anesthesia with ultrasound guidance can help decrease complications of regional blocks. In the lumbar area, the lumbar paravertebral space is a potential space formed by the vertebral bodies, intervertebral discs and intervertebral foramina medially, the psoas major muscle anterolaterally and the erector spinae muscles, the transverse process and intertransverse ligaments posteriorly. There is no costotransverse ligament in the lumbar region. The lumbar spinal nerve roots run through the paravertebral space then continue through the psoas major muscle where they form the lumbar plexus.The spinal nerves in this space are devoid of a fascial sheath making them exceptionally susceptible to local anesthetics. The diaphragm and psoas muscle separate the thoracic and lumbar paravertebral areas; however, communication may occur via the medial and lateral arcuate ligaments of the diaphragm. Field block can be done by subcutaneous injection of a local anesthetic in an area bordering on the field to be anesthetized. It is safe, simple, effective, and economical, without post anesthesia side effects. Furthermore, local anesthesia administered before the incision produces longer postoperative analgesia because of local infiltration, theoretically, inhibits the build-up of local nociceptive molecules, and therefore, there is better pain control in the postoperative period. The aim of this study is to compare the analgesic and autonomic effects of unilateral abdominal ultrasound guided paravertebral block with field block in pediatric inguinal hernia surgery. This study hypothesizes that unilateral abdominal ultrasound guided paravertebral block may be more superior to field block in reducing intra and postoperative pain in the pediatric inguinal hernia. The analgesic efficacy and duration of ultrasound (US) guided unilateral lumbar paravertebral block and field block were compared when dexmedetomidine and epinephrine were added as adjuvants to bupivacaine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar paravertebral group
Arm Type
Active Comparator
Arm Description
After general anesthesia, the patient is placed prone. To establish the level of the block, we used US-counting of vertebrae. After determining the lumbar one level, the block performed at a parallel line 2 cm lateral to the spinous process, the transducer is moved until the corresponding transverse process is identified. Utilizing an in-plane approach from lateral to medial, a spinal needle is advanced until contact with the transverse process. The needle is withdrawn and redirected caudally under the transverse process helped by the loss of resistance technique. the solution is slowly injected after negative aspiration for blood.
Arm Title
The field block group
Arm Type
Active Comparator
Arm Description
The ilioinguinal nerve block was done at one fingerbreadth from the anterior superior iliac spine in a line with the pubic tubercle, The injection was done after the bob of the needle after passing the external oblique aponeurosis and muscle and 5ml of the solution is injected. The rest of the solution is injected in the incision line.
Intervention Type
Drug
Intervention Name(s)
Lumbar paravertebral group
Intervention Description
A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
Intervention Type
Drug
Intervention Name(s)
The field block group
Intervention Description
A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
Primary Outcome Measure Information:
Title
The total dose of analgesics required in the post-operative periods
Description
Fentanyl in microgram.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Modified Faces Legs Activity Cry Consolability Revised pain Scale
Description
pain score of 5 items (Faces, Legs, Activity, Cry, Consolability) each of 0, 1, or 2 points. 0= express no pain, 1= mild pain, 2= the highest pain indicator. A total score 0 = Relaxed and comfortable. 1-3 = Mild discomfort. 4-6 = Moderate pain. 7-10 = Severe pain.
Time Frame
postoperative at 1, 2, 4, 8,16, 24 hours.
Title
Mean Blood pressure
Description
millimeter mercury
Time Frame
Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
Title
Heart rate
Description
beat/minutes
Time Frame
Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
Title
Modified Ramsay sedation scale.
Description
a scale from (1- 6), 1 = anxious; 2 = oriented & tranquil; 3 = sedated, but responds to commands; 4 = asleep, brisk glabellar reflex or response to loud noise; 5 = asleep, slugglish glabellar reflex or response to loud noise; 6 = asleep with no response to painful stimulus
Time Frame
postoperative at 2, 4, 6, 12, 16, 24 hours.
Title
Parents' satisfaction score
Description
in a visual analogue score from (0-10), 0= minimal satisfaction, 10 = the highest satisfaction.
Time Frame
postoperative after 24 hours.
Title
Adverse effects including nausea and vomiting, bradycardia (heart rate less than 60 beat/minute)
Description
percent
Time Frame
postoperatively in the first 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients subjected to an elective unilateral inguinal hernia repair. American Society for Anesthesiologists physical status grades I and II. Exclusion Criteria: 1. Parental refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, etc.) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at the site of the block. 6. Known intolerance to the study drugs. -
Facility Information:
Facility Name
Mansoura University Children's Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
after publication
IPD Sharing Time Frame
no limit
IPD Sharing Access Criteria
e mail: ayatebrahimeid@gmail.com

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Lumbar Paravertebral in Hernia Surgery

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