To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia RepairNCT04462510
To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults
A study testing Block/Local infiltration in people with To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair, run by Aga Khan University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
- What is being tested?
- Block/Local infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2019to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Block/Local infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block/Local infiltrationProcedure or surgery
Also called ILI/IHG Block, Local Infiltration
One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief
| Study group | Role | What they receive |
|---|---|---|
| Illioinguinal/Illiohypogastric Block | Experimental | A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given Receives: Procedure: Block/Local infiltration |
| Wound infiltration | Experimental | Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed. Receives: Procedure: Block/Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This was measured at 0 hours (immediately) after the surgery
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.
Measured: This was measured at 2 hours after the surgery
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.
Measured: This was measured at 6 hours after the surgery
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.
Measured: This was measured at 12 hours after the surgery
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.
Measured: This was measured 24 hours after the surgery
Secondary outcomes (2)
Tramadol consumption
Amount of total tramadol consumption was recorded
Measured: This was measured at 0,2,6,12 and 24 hours after the surgery
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
Measured: This was assessed at the end of 24 hours post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start30 Mar 2019
- Primary completion26 Jun 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Summaiya Ahsan Ali, Aga Khan University
- Investigators
- Summaiya Ali, MBBS, Principal investigator, Anesthesia Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462510
- Sponsor's protocol ID
- AgaKhanU1
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khan RI, Hameed M, Ali SA. Comparison of ilioinguial/iliohyphogastic nerves block with woundinfiltration on postoperative pain: A randomised controlled trial. J Pak Med Assoc. 2024 Nov;74(11):1922-1926. doi: 10.47391/JPMA.10859.
PubMed 39548607
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04462510
- Acronym / sponsor ID
- AgaKhanU1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
| Arm | Type | Receives |
|---|---|---|
| Illioinguinal/Illiohypogastric Block | Experimental | Procedure: Block/Local infiltrationA single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given |
| Wound infiltration | Experimental | Procedure: Block/Local infiltrationSurgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- BMI below 18 or above 35 kg/m2
- Local anesthetic allergy
- Pregnancy
- Infection at injection site
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Block/Local infiltrationAlso: ILI/IHG Block, Local InfiltrationOne group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief | Procedure or surgery | Illioinguinal/Illiohypogastric Block, Wound infiltration |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Tramadol consumption
Time frame: This was measured at 0,2,6,12 and 24 hours after the surgery
Patient satisfaction
Time frame: This was assessed at the end of 24 hours post operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 39548607Khan RI, Hameed M, Ali SA. Comparison of ilioinguial/iliohyphogastic nerves block with woundinfiltration on postoperative pain: A randomised controlled trial. J Pak Med Assoc. 2024 Nov;74(11):1922-1926. doi: 10.47391/JPMA.10859.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Summaiya Ali, MBBS principal investigator
Anesthesia Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Block/Local infiltration in people with To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: This was measured at 0 hours (immediately) after the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.