AnalgesiaTAPLAPNCT06058715
TAP Block Versus Conventional Systemic Analgesia
A study testing Transverse Abdominal Plan block (TAP block) in people with Analgesia, run by Ministry of Scientific Research, Tunisia at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Transverse Abdominal Plan block (TAP block)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Sep 2023to Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana
Who cannot join
- Severe renal insufficiency (GFR < 30 ml/min)
- Severe hepatic insufficiency (TT ≤ 50%)
- Severe COPD (FEV1 > 30%)
- Metastatic malignancy
- Hematologic disease or a congenital clotting disorder
- Preoperative opioid use
Show all 10Show fewer
- Age under 18 years
- Pregnancy or breast-feeding
- Hyper-reactivity toward ropivacaine
- Estimated risk for conversion to open surgery > 50%
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia
Aryanah
About this study
Official title: TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
Read the detailed description
Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
- Conditions
- Analgesia
- Being tested
- Transverse Abdominal Plan block (TAP block)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse Abdominal Plan block (TAP block)Procedure or surgery
Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane and after placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, 20 ml of ropivacaine 0.25% is injected bilaterally. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane. After placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, Ropivacaine 0.25% (Naropin) is injected bilaterally at the dose of 0.5 mg/kg. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data.
No additional regional anesthesia, including epidural or spinal anesthesia, is given.
The patients are mobilized in the recovery room 2 h after surgery. Receives: Procedure: Transverse Abdominal Plan block (TAP block) |
| Conventional analgesia | Active comparator | No additional regional anesthesia, including epidural or spinal anesthesia, is given.
For postoperative analgesia, all patients receive paracetamol intravenously at the dose of 1 g three times up to 24 hours, starting immediately after surgery. Complementary opioids are given on request when pain numerical rating scale (pain NRS) : NRS > 3 at rest or for pain NRS > 5 on exercise. Oxycodone is given intravenously at the dose of 0.05 mg/kg only in the recovery room up to two hours after the surgery. It is administrated intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery. Then, it is given orally at the dose of 0.2 mg/kg from 24 to 48 hours after surgery. Receives: Procedure: Transverse Abdominal Plan block (TAP block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption during the first 48 h postoperatively.
Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS > 3 at rest or for pain NRS > 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery.
At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.
Measured: Every six hours
Secondary outcomes (2)
Pain intensity on a numerical rating scale (pain NRS, 0-10)
pain intensity is measured 30 min after arrival and then every hour until the patient is discharged to the ward. In the ward, the pain NRS score is measured for each consecutive 6-h block. Means of the first and second 6-h blocks and third and fourth blocks are calculated and used for further analysis. Additionally, the maximal daily pain NRS scores are collected. At the time of discharge, patients evaluate their satisfaction with pain management as a whole (scale 0-3: 0 poor; 3 excellent).
Measured: Every six hours
Postoperative evaluation at 4 weeks
At 4 weeks postoperatively, all patients are contacted either by phone and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.
Measured: At 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Sep 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Scientific Research, Tunisia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sana Landolsi, Ministry of Scientific Research, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058715
- Sponsor's protocol ID
- TAP1-LAP2
- Acronym
- TAPLAP
- Status last verified
- Sep 2023
- First submitted
- 8 Jun 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06058715
- Acronym / sponsor ID
- TAPLAP / TAP1-LAP2
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Ministry of Scientific Research, TunisiaOther government
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 28 Sep 2023 (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 goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
Detailed description
Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: Transverse Abdominal Plan block (TAP block)Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane. After placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, Ropivacaine 0.25% (Naropin) is injected bilaterally at the dose of 0.5 mg/kg. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data. No additional regional anesthesia, including epidural or spinal anesthesia, is given. The patients are mobilized in the recovery room 2 h after surgery. |
| Conventional analgesia | Active comparator | Procedure: Transverse Abdominal Plan block (TAP block)No additional regional anesthesia, including epidural or spinal anesthesia, is given. For postoperative analgesia, all patients receive paracetamol intravenously at the dose of 1 g three times up to 24 hours, starting immediately after surgery. Complementary opioids are given on request when pain numerical rating scale (pain NRS) : NRS > 3 at rest or for pain NRS > 5 on exercise. Oxycodone is given intravenously at the dose of 0.05 mg/kg only in the recovery room up to two hours after the surgery. It is administrated intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery. Then, it is given orally at the dose of 0.2 mg/kg from 24 to 48 hours after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana
Key exclusion criteria (10 listed)
- Severe renal insufficiency (GFR < 30 ml/min)
- Severe hepatic insufficiency (TT ≤ 50%)
- Severe COPD (FEV1 > 30%)
- Metastatic malignancy
- Hematologic disease or a congenital clotting disorder
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 |
|---|---|---|
| Transverse Abdominal Plan block (TAP block)Bilateral TAP block is administered intraoperatively at laparoscopy, directly after insufflation and insertion of the first trocar and camera. The ultrasound probe is placed longitudinally on the midaxillary line near umbilicus, and the transversus abdominis and internal oblique muscles are scanned and observed. The needle (22-gauge 90 mm disposable spinal needle) is inserted in plane and after placing the needle-tip into the fascia between transversus abdominis and internal oblique muscles, 20 ml of ropivacaine 0.25% is injected bilaterally. It is all done by one Anesthetist which is expert in that area and is not in charge of collecting the data. | Procedure or surgery | Conventional analgesia, TAP block |
Primary outcome
Opioid consumption during the first 48 h postoperatively.
Time frame: Every six hours
Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS > 3 at rest or for pain NRS > 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery. At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.
2 secondary outcomes
Pain intensity on a numerical rating scale (pain NRS, 0-10)
Time frame: Every six hours
Postoperative evaluation at 4 weeks
Time frame: At 4 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse Abdominal Plan block (TAP block) in people with Analgesia, run by Ministry of Scientific Research, Tunisia 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 1 inclusion and 10 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 28 Sep 2023. 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?
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?
Opioid consumption during the first 48 h postoperatively. (time frame: Every six hours). 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 28 Sep 2023.