Lumbar Paravertebral in Hernia Surgery

NCT03408184 | Completed DMC

• 1 other identifier: MS/16.06.19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The total dose of analgesics required in the post-operative periods

  Fentanyl in microgram.

  24 hours postoperatively

Secondary Outcomes (6)

• Modified Faces Legs Activity Cry Consolability Revised pain Scale

  postoperative at 1, 2, 4, 8,16, 24 hours.

• Mean Blood pressure

  Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.

• Heart rate

  Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.

• Modified Ramsay sedation scale.

  postoperative at 2, 4, 6, 12, 16, 24 hours.

• Parents' satisfaction score

  postoperative after 24 hours.

Study Arms (2)

Lumbar paravertebral group

ACTIVE COMPARATOR

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 The needle is withdrawn and redirected caudally under the transverse process helped by the loss of resistance technique.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.

Drug: Lumbar paravertebral group

The field block group

ACTIVE COMPARATOR

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.

Drug: The field block group

Interventions

Lumbar paravertebral group DRUG

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

Lumbar paravertebral group

The field block group DRUG

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

The field block group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Children's Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 23, 2018
• Study Start: August 9, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: no limit
• Access Criteria: e mail: ayatebrahimeid@gmail.com

Locations

EG (1)