Clinical trial NCT04462510: To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults
Official title: A Comparison Between Ultrasound Guided Ilioinguial/Iliohyphogastic Nerves Block and Infiltration of Wound With Ropivacaine on Post-Operative Pain After Open Repair of Unilateral Inguinal Hernia in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
Primary purpose: TREATMENT

Brief summary: This study was conducted to assess the postoperative painscores in patients undergoing open inguinal hernia repair between two groups receiving either U/S guided ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves blocks and wound infiltration) was measured alongwith comparison of opioid use between the two groups over 24 hours postoperatively was made. Patient satisfaction between the two groups was also assessed by the Likert scale.

Detailed description: Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal analgesia is recommended to overcome this issue. Therefore this randomized controlled trial was conducted to compare the analgesic efficacy of ultrasound guided Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.

This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised controlled trial conducted from March 2019 to October 2019. 60 participants for elective unilateral open inguinal hernia repair were included. Patients were randomly allocated (30 each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25% Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site to provide postoperative analgesia. Postoperative pain at rest (static) and on movement (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol consumption and time for first tramadol requirement was noted.

In addition complications related to IHG block and LA infiltration were observed.Patient satisfaction was also gauged by the LIKERT scale in the questionairre.

Eligibility criteria: Inclusion Criteria:

* Adult patients between the ages of 18-75 years, scheduled for unilateral open primary hernia repair electively
* American society of Anaesthesiologists(ASA) standard I to IV

Exclusion Criteria:

* BMI below 18 or above 35 kg/m2
* Local anesthetic allergy
* Pregnancy
* Infection at injection site
* Coagulation disorders
* Contraindication to any drug used in the standard anesthesia regimen

Primary outcomes:
measure: Pain score
timeFrame: This was measured at 0 hours (immediately) after the surgery
measure: Pain score
timeFrame: This was measured at 2 hours after the surgery
measure: Pain score
timeFrame: This was measured at 6 hours after the surgery
measure: Pain score
timeFrame: This was measured at 12 hours after the surgery
measure: Pain score
timeFrame: This was measured 24 hours after the surgery
Secondary outcomes:
measure: Tramadol consumption
timeFrame: This was measured at 0,2,6,12 and 24 hours after the surgery
measure: Patient satisfaction
timeFrame: This was assessed at the end of 24 hours post operatively.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sind
Study officials:
affiliation: Anesthesia Resident
name: Summaiya Ali, MBBS
role: PRINCIPAL_INVESTIGATOR
References: