To assess the effect of hydroxyethyl starch(HES) solution in prolonging the duration of pain relief for hernia repair in children after inguinal nerve block and wound infiltration.

To study the efficacy of 6% hydroxyethyl starch(HES) with 0.25% ropivacaine for ilioinguinal/iliohypogastric block along with wound infiltration in prolonging duration of post operative analgesia in paediatric unilateral inguinal hernia repair

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047157

Enrollment

Registered

2022-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Ilioinguinal/Iliohypogastric block and wound infiltration: After giving GA, the 0.25% ropivacaine will be diluted with 6% hydroxyethyl starch (HES) and will be used for ilioinguinal/ili

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age 1 to 7 years. 2)Undergoing inguinal hernia surgeries. 3)ASA I and ASA II category patients. 4)All those parents or legal guardians giving consent.

Exclusion criteria

Exclusion criteria: 1)Parent or guardian refusal. 2)Patients with history of coagulation disorder. 3)Infection at proposed IL/IH block. 4)Pre-existing neurological disease. 5)Known allergy to the local anesthetic or hydroxyethyl starch.

Design outcomes

Primary

Measure	Time frame
Any prolongation of duration of analgesia following ilioinguinal/iliohypogastric block and wound infiltration with hydroxyethyl starch(HES) and ropivacaine in comparison to normal saline(NS) and ropivacaine in paediatric inguinal hernia repairTimepoint: 1. Following GA, ilioinguinal/iliohypogastric block will be given. 2.At the end of surgery, wound infiltration will be given. 3.Assess duration of post operative analgesia in PACU.	—

Measure

Time frame

Any prolongation of duration of analgesia following ilioinguinal/iliohypogastric block and wound infiltration with hydroxyethyl starch(HES) and ropivacaine in comparison to normal saline(NS) and ropivacaine in paediatric inguinal hernia repairTimepoint: 1. Following GA, ilioinguinal/iliohypogastric block will be given. 2.At the end of surgery, wound infiltration will be given. 3.Assess duration of post operative analgesia in PACU.

—

Secondary

Measure	Time frame
1.Any analgesic requirement within 6 hrs post op. 2.To assess the parental satisfaction regarding analgesia at 24 hrs. 3.To assess the discharge time from PACU.Timepoint: 1.To assess analgesic requirement in PACU. 2.Parental satisfaction will be telephonically asked using a 4 point Likert scale(1 - 4). 3.To assess discharge time from PACU by Modified Aldrete Score.	—

Countries

India

Contacts

Public ContactDr Siddharth B

AIIMS New Delhi

drgpd@yahoo.com9013232965

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026