Postoperative Pain
Conditions
Brief summary
This randomized controlled trial aims to compare the analgesic efficacy of local wound infiltration with Ropivacaine versus Caudal Block with Ropivacaine in pediatric patients undergoing surgery for inguinal hernia
Detailed description
Pediatric patients undergoing inguinal hernia surgeries experience postoperative pain. Conventional pain management methods, including opiates, may pose significant side effects. This study addresses the imperative need for optimizing postoperative pain management by systematically investigating and comparing the analgesic effects of local wound infiltration versus caudal block. The study involves 100 patients allocated into two equal groups using a lottery method: one group receiving caudal block; and other group local wound infiltration . Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered.
Interventions
DRUGCaudal Block with Ropivacaine Intervention
Administered after surgery using the landmark technique with 0.25% ropivacaine at a dose of 2mg/kg body weight.
DRUGLocal Wound Infiltration with Ropivacaine Intervention
Administered after surgery by pediatric surgeons using 0.5% ropivacaine at a dose of 2mg/kg body weight into the groin skin crease incision.
DRUGIntravenous Paracetamol Suspension Intervention
Administered as rescue analgesia at a dose of 15 ml/kg body weight if the patient's postoperative pain score reaches 3 or higher on the Hannallah Modified Objective Pain Scale.
Sponsors
Fatima Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female patients aged 2-10 years. 2. Patients undergoing open elective herniotomy. 3. Patients classified as ASA (American Society of Anesthesiologists) classes I and II.
Exclusion criteria
1. Patients with recurrent, bilateral, complicated, or obstructed hernias. 2. History of bleeding disorders. 3. Presence of congenital anomalies of the spine. 4. History of drug allergy. 5. Infection at the caudal injection site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Analgesic Requirement | Within first 8 hours after surgery | Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered. |
| Postoperative Analgesia requirement | Within first 8 hours after surgery | Post-operative pain will be assessed at 30 minutes, and 1, 2, 4, 6, and 8 hours using the Hannallah Modified Objective Pain Scale. At any stage, if a pain score of 3 or more is observed, it will be considered severe pain, and rescue analgesia in intravenous paracetamol suspension at 15 ml/kg body weight will be administered. |
Countries
Pakistan
Outcome results
None listed