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Lumbar Paravertebral in Hernia Surgery

Comparison Between Lumbar Paravertebral and Field Blocks in Pediatric Inguinal Hernia Surgery.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03408184
Enrollment
60
Registered
2018-01-23
Start date
2016-08-09
Completion date
2017-08-01
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGLumbar paravertebral group

A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.

DRUGThe field block group

A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
The total dose of analgesics required in the post-operative periods24 hours postoperativelyFentanyl in microgram.

Secondary

MeasureTime frameDescription
Mean Blood pressureBasal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.millimeter mercury
Heart rateBasal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.beat/minutes
Modified Faces Legs Activity Cry Consolability Revised pain Scalepostoperative at 1, 2, 4, 8,16, 24 hours.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.
Parents' satisfaction scorepostoperative after 24 hours.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)postoperatively in the first 24 hours.percent
Modified Ramsay sedation scale.postoperative at 2, 4, 6, 12, 16, 24 hours.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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026