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Post-operative Pain Relief for Paediatric Inguinal-Scrotal Surgery

D

Dr Kumarvel Veerappan

Status

Unknown

Conditions

Hernia, Inguinal

Treatments

Procedure: Caudal block
Procedure: Nerve Block
Drug: Standarising intraoperative pain relief

Study type

Interventional

Funder types

Other

Identifiers

NCT03167047
16/LO/1187

Details and patient eligibility

About

Two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). A pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound.

One potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. This study is to demonstrate that this method is as effective as the use of a regional nerve block.

Enrollment

50 estimated patients

Sex

All

Ages

1 month to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children undergoing day case elective inguinal-scrotal surgery

Exclusion criteria

  • Contraindication to technique
  • Significant comorbidities
  • Patient/parent refusal

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Caudal block
Active Comparator group
Description:
Caudal epidural given for post-operative pain relief. Dose used is 1.5ml/kg of weak Levo-Bupivacaine solution (0.125%). Patients will also receive standardised pain relief of paracetamol and fentanyl
Treatment:
Procedure: Caudal block
Drug: Standarising intraoperative pain relief
Nerve block
Active Comparator group
Description:
Peripheral nerve block given for post operative pain relief. Levo-Bupivacaine 0.25% 2mg/Kg given under ultrasound guidance. Patients will also receive standardised pain relief of paracetamol and fentanyl
Treatment:
Procedure: Nerve Block
Drug: Standarising intraoperative pain relief

Trial contacts and locations

1

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Central trial contact

Kumarvel Veerappan, FRCA; Robert Hughes, MA

Data sourced from clinicaltrials.gov

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