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CompletedNCT04462510Updated Jul 8, 2020

To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults

An interventional study of Block/Local infiltration in To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Aga Khan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2019, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Illioinguinal/Illiohypogastric Block

    A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given

    Procedure: Block/Local infiltration

  • Experimental
    Wound infiltration

    Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.

    Procedure: Block/Local infiltration

Interventions

  • ProcedureBlock/Local infiltration

    One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief

    Also known as: ILI/IHG Block, Local Infiltration

06

What researchers measure

Primary outcomes

  1. Pain score

    Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

    Time frame: This was measured at 0 hours (immediately) after the surgery

  2. Pain score

    Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

    Time frame: This was measured at 2 hours after the surgery

  3. Pain score

    Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

    Time frame: This was measured at 6 hours after the surgery

  4. Pain score

    Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

    Time frame: This was measured at 12 hours after the surgery

  5. Pain score

    Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

    Time frame: This was measured 24 hours after the surgery

Secondary outcomes

  1. Tramadol consumption

    Amount of total tramadol consumption was recorded

    Time frame: This was measured at 0,2,6,12 and 24 hours after the surgery

  2. Patient satisfaction

    This was measured on a 5 point Likert scale. A question was asked that 'was the anesthetic care and pain relief effective?' The scale included the options of Strongly disagree, Disagree, Neutral, Agree, Strongly Agree

    Time frame: This was assessed at the end of 24 hours post operatively.

07

Study locations

1 site
  • Aga Khan University Hospital
    Karachi, Sind 75500, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04462510
Lead sponsor
Aga Khan University
Responsible party
Summaiya Ahsan Ali (Principal Investigator, Aga Khan University) — Principal investigator
First posted
Jul 8, 2020
Start date
Mar 30, 2019
Primary completion
Jun 26, 2019
Completion
Oct 25, 2019
Last update
Jul 8, 2020

Study contacts

Summaiya Ali, MBBS
principal investigator · Anesthesia Resident

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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