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Completed

NCT Number: NCT04462510

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, 75500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Block/Local infiltration

Procedure

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

Other names: ILI/IHG Block, Local Infiltration

Primary outcomes

  1. Pain score

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

    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.

  2. Pain score

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

    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.

  3. Pain score

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

    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.

  4. Pain score

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

    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.

  5. Pain score

    Time frame: This was measured 24 hours after the surgery

    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.

Secondary outcomes

  1. Tramadol consumption

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

    Amount of total tramadol consumption was recorded

  2. Patient satisfaction

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

    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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.