Ventral HerniaNCT03342040
Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair
A study testing Laparoscopic ventral hernia repair with TAP block and Laparoscopic ventral hernia repair without TAP block in people with Ventral Hernia, run by GEM Hospital & Research Center at 1 site in India.
Trial summary
The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Laparoscopic ventral hernia repair with TAP block and Laparoscopic ventral hernia repair without TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 15 Oct 2017to 1 Feb 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing laparoscopic ventral hernia repair during the study period
Who cannot join
- Age <15 or greater than 75 years
- ASA > 3
- Obstructed , recurrent or strangulated hernia
- Lap assisted open hernia repair
- Patients undergoing component separation
- Parastomal hernia, spigelian hernia, lumbar hernia
Show all 9Show fewer
- Patients with Chronic kidney disease, bronchial asthma
- Patients allergic to bupivacaine or NSAIDs
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial: Transverse Abdominis Plane Block Versus no Block in Laparoscopic Ventral Hernia Repair
The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.
Read the detailed description
Patients meeting inclusion criteria would be randomised after admission. Those patients in experimental arm shall receive the TAP block under USG guidance while those in control arm do not receive any block. Surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. The total amount of analgesic required by the patient is measured. Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow up review.
- Conditions
- Ventral Hernia
- Being tested
- Laparoscopic ventral hernia repair with TAP block, Laparoscopic ventral hernia repair without TAP block
- Keywords
- TAP block, laparoscopic IPOM, post operative pain
- Medical subject headings
- Hernia, Ventral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ventral hernia repair with TAP blockProcedure or surgery
Also called Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection
Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery
Laparoscopic ventral hernia repair without TAP blockProcedure or surgery
No block administered during Laparoscopic ventral hernia surgery
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | Patients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance Receives: Procedure: Laparoscopic ventral hernia repair with TAP block |
| No TAP block | Active comparator | Patients undergoing laparoscopic ventral hernia repair without TAP block Receives: Procedure: Laparoscopic ventral hernia repair without TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative cumulative analgesic requirement
The amount of analgesic required by the patient during hospital stay
Measured: 24 hours after surgery
Secondary outcomes (1)
Post-operative hospital stay
The time taken to get discharged from the hospital
Measured: 7 days from primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start15 Oct 2017
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies 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
- Prospective double blinded balanced allocation, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEM Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C C Palanivelu, MS, MCh, Principal investigator, Gem Hospital and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342040
- Sponsor's protocol ID
- GemHRC
- Status last verified
- Feb 2019
- First submitted
- 29 Sep 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Transverse Abdominis Plane Block Versus no Block in Laparoscopic Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT03342040
- Acronym / sponsor ID
- GemHRC
- Conditions
- Ventral Hernia
- Keywords
- TAP block, laparoscopic IPOM, post operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- GEM Hospital & Research CenterUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 14 Nov 2017 (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.
The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.
Detailed description
Patients meeting inclusion criteria would be randomised after admission. Those patients in experimental arm shall receive the TAP block under USG guidance while those in control arm do not receive any block. Surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. The total amount of analgesic required by the patient is measured. Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow up review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective double blinded balanced allocation, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: Laparoscopic ventral hernia repair with TAP blockPatients undergoing laparoscopic ventral hernia repair with TAP block with 0.2% ropivacaine under ultrasound guidance |
| No TAP block | Active comparator | Procedure: Laparoscopic ventral hernia repair without TAP blockPatients undergoing laparoscopic ventral hernia repair without TAP block |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing laparoscopic ventral hernia repair during the study period
Key exclusion criteria (9 listed)
- Age <15 or greater than 75 years
- ASA > 3
- Obstructed , recurrent or strangulated hernia
- Lap assisted open hernia repair
- Patients undergoing component separation
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 |
|---|---|---|
| Laparoscopic ventral hernia repair with TAP blockAlso: Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injectionTransverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery | Procedure or surgery | TAP block |
| Laparoscopic ventral hernia repair without TAP blockNo block administered during Laparoscopic ventral hernia surgery | Procedure or surgery | No TAP block |
Primary outcome
Post operative cumulative analgesic requirement
Time frame: 24 hours after surgery
The amount of analgesic required by the patient during hospital stay
1 secondary outcome
Post-operative hospital stay
Time frame: 7 days from primary surgery
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 15 Feb 2019.
- Individual participant dataSharing planned: No
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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.
C C Palanivelu, MS, MCh principal investigator
Gem Hospital and research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ventral hernia repair with TAP block and Laparoscopic ventral hernia repair without TAP block in people with Ventral Hernia, run by GEM Hospital & Research Center at 1 site in India.
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 1 inclusion and 9 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 15 Feb 2019. 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 India. 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?
Post operative cumulative analgesic requirement (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.