Post Operative PainNCT04176770
Comparaison of ESP Block and TAP Block
A study testing ESP Block and TAP Block in people with Post Operative Pain, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ESP Block and 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
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2019to 30 Jun 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- ASA status I or II
- scheduled for laparoscopic cholecystectomy
Who cannot join
- laparotomy
- unplanned ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy
This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.
Read the detailed description
This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
or
-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
- Conditions
- Post Operative Pain
- Being tested
- ESP Block, TAP Block
- Keywords
- Laparoscopic cholecystectomy, Post Operative, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP BlockProcedure or surgery
ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
TAP BlockProcedure or surgery
TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Experimental | ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5. Receives: Procedure: ESP Block |
| TAP Block | Experimental | TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5% Receives: Procedure: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative analgesia
Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)
Measured: 24 hours after intervention
Secondary outcomes (1)
post operative analgesic consumption
Amount of Morphin needed for analgesia
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami Mebazaa, Professor, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176770
- Sponsor's protocol ID
- ESP in cholecystectomy
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESP Versus TAP for Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04176770
- Acronym / sponsor ID
- ESP in cholecystectomy
- Conditions
- Post Operative Pain
- Keywords
- Laparoscopic cholecystectomy, Post Operative, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Nov 2019 (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 aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.
Detailed description
This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
or
-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP group | Experimental | Procedure: ESP BlockESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5. |
| TAP Block | Experimental | Procedure: TAP BlockTAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5% |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- ASA status I or II
- scheduled for laparoscopic cholecystectomy
Key exclusion criteria (2 listed)
- laparotomy
- unplanned ICU admission
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 |
|---|---|---|
| ESP BlockESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5. | Procedure or surgery | ESP group |
| TAP BlockTAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5% | Procedure or surgery | TAP Block |
Primary outcome
Post Operative analgesia
Time frame: 24 hours after intervention
Post operative analgesia assessed with Numerical rating scale (0=minimum, 10= Maximum)
1 secondary outcome
post operative analgesic consumption
Time frame: 24 hours after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 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.
Mhamed Sami Mebazaa, Professor principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP Block and TAP Block in people with Post Operative Pain, run by Mongi Slim Hospital at 1 site in Tunisia.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Nov 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 Tunisia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative analgesia (time frame: 24 hours after intervention). 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 29 Nov 2019.