Effectiveness of Single Paravertebral Blockade Injection for Herniorrhaphy in Children

NCT02984800 | Unknown

• 1 other identifier: 3122016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable, timely and effective technique generates the investigation of a single PVB injection for children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind this investigation. First, possible spread of single PVB injection in the lumbar area over dermatomes corresponding to the inguinal hernia region in children likewise the spread over multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves, all three arising from L1-L2 level; thus, a single PVB injection at this level could provide unilateral segmental anesthesia.

Conditions

Reduce Pain After Herniorrhaphy

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  Analgesics consumed will be recorded

  24 hours postoperatively

Secondary Outcomes (1)

• Hemodynamic stability

  During the operation (approximately one hour)

Study Arms (2)

Group I

EXPERIMENTAL

Patients will receive one PVB injection at L1-L2 .

Other: Anesthesia induction; Other: PVB injection at L1-L2

Group III

EXPERIMENTAL

Patients will receive three PVB injections at T12-L1, L1-L2 and L2-L3.

Other: Anesthesia induction; Other: PVB injections at T12-L1, L1-L2 and L2-L3.

Interventions

Anesthesia induction OTHER

All patients will have inhaled induction of anesthesia by facemask using oxygen and 8% sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained until completion of surgery.

Group I; Group III

PVB injection at L1-L2 OTHER

Patients will receive a single PVB injection at L1-L2 and placebo PVB injections at T12-L1 and L2-L3.

Group I

PVB injections at T12-L1, L1-L2 and L2-L3. OTHER

Patients will have PVB injections at T12-L1, L1-L2 and L2-L3.

Group III

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• elective unilateral herniorrhaphy

You may not qualify if:

• history of allergic reactions to local anesthetics
• bleeding diatheses
• spinal abnormality

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

Central Study Contacts

Zoher Naja, MD

CONTACT

zouhnaja@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)