Neuromuscular BlockadePhase 4NCT03701256
Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures.
A Phase 4 study testing Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus in people with Neuromuscular Blockade and Regional Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
A monocentric, prospective, randomized controlled trial, including patients proposed for a laparoscopic gynecologic surgery comparing the muscular relaxing effect of a bilateral ultrasound-guided Transversus Abdominis Plane block to usual neuromuscular blockade agent (Atracurium) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade, Regional Anesthesia
- What is being tested?
- Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2015to 31 Oct 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Association of anesthesiologists' class I to III (ASA I to ASA III)
- undergoing laparoscopic gynecologic procedures
- Non inclusion Criteria:
- patients' refusal to be part of the study
- ASA IV and higher
- known allergic history to Propofol or any of its components (eggs, soya and beans, etc.), suxamethonium, Fentanyl or Atracurium.
- Patients who presents any regional anesthesia contraindication as clotting disorders, injection site infection and allergy to local anesthetics
- Psychiatric and neurologic disorders and the inability to understand pain scores and the study protocol
Who cannot join
- unsuccessful TAP block
- Observed anesthesia or surgical incident which requires the end of the ongoing procedure or the conversion to laparotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures. Do we Really Still Need the Systemic Neuromuscular Blocking Agents?
A monocentric, prospective, randomized controlled trial, including patients proposed for a laparoscopic gynecologic surgery comparing the muscular relaxing effect of a bilateral ultrasound-guided Transversus Abdominis Plane block to usual neuromuscular blockade agent (Atracurium)
Read the detailed description
We conducted a monocentric randomized single blinded controlled trial for six months starting from February 2015 until July 2015. Patients undergoing laparoscopic gynecologic procedures were included and randomly assigned in two groups receiving either an ultrasound guided TAP block (TAP group) or usual Neuromuscular blockade curare type: Atracurium (TRAC group). Randomization was simple and the allocation sequence was generated by a random number table via computer. The surgeon in charge was blinded about the performance of a TAP block.
Anesthesia protocol was almost the same in the two groups apart from the TAP block performance in the study group and the use of the neuromuscular blockade . No premedication was given to before the procedure. Monitoring was standard with a 5 leads electrocardioscope, non-invasive arterial pressure, pulsed oximetry (SpO2) and pressure of end tidal expired CO2 (PetCO2). Peripheral venous access was obtained and a 0.9 % saline vascular prefilling was done via an 18 or a 16 Gauges (G) percutaneous line in the non-dominant superior member. In the TRAC group, induction was given with 2.5 mg Propofol, 3 γ/kg Fentanyl and 0.6 mg/kg Atracurium. In The TAP group general anesthesia was induced, after a 3 minutes pre-oxygenation, with 3 γ/kg fentanyl, 2.5 mg/kg Propofol and 1mg/kg Suxamethonium. Thereafter the TAP block was performed under ultrasonography guidance with a Samsung (MySonoU6) transportable device and a linear high frequency 5-12 Megahertz transducer. The probe was oriented transversely on the antero-lateral abdominal wall and the image depth was set between 4 and 6 cm. Once anatomic structures were visualized and well distinct, the probe was moved posteriorly until the mid-axillary line between the 12th rib and the iliac crest. Operator should be able to identify from top to bottom: the subcutaneous fat tissue (hypo-echogenic), External Oblic Abdominal Muscle (EOAM), Internal Oblic Abdominal Muscle (IOAM), Transverse Abdominis Muscle (TAM) (heterogeneous), peritoneum (hyper-echogenic) and underneath intraabdominal organs both moving with respiration. The junction between the posterior fascia of the IOAM and the anterior fascia of the TAM is also hyper-echogenic and represent the region of interest as it is the local anesthetic injection site. The puncture was proceeded with 100 mm lenght needle 21 G (Vygon, France) needle witch progressed obliquely through the abdominal wall. Operator realized an in plane ultrasound guided approach. As soon as the tip of the needle was placed in the junction between the IOAM and TAM and the aspiration test negative, a priming of 3 ml local anesthetic injection was used in order to unsure a correct position of the needle. In this case the injectate would appear as a hypo-echogenic oval well-shaped volume spreading between the two muscle layers. An inaccurate injection was suspected by the absence of the described image. Intramuscular injection could appear as a poorly defined hyper-echogenic image within the muscle. Once the correct position verified, the rest of the 20 ml of the 2.5% bupivacaine is injected. The contralateral block was performed equally. Anesthesia was maintained by a total intravenous anesthesia in both groups. Fentanyl was systematically reinjected every 30 minutes and Propofol was infused at 8-10 mg/kg/h. In the TRAC group, Atracurium reinjections were guided by the monitoring of the NMB every 20 minute at a dose equal to 0.1mg/kg to be reevaluated after 5 minutes. In the TAP group, a rescue injection of NMB agent was indicated in case of diaphragmatic contractions, surgeons' complaint or patients' movement after optimization of narcosis by increasing propofol infusing speed to a maximum of 5 mg/kg/h beyond the baseline speed and checking analgesia. In both groups patients were ventilated on a volume assisted mode with 50 % of inspired fraction of Oxygen and 4-6 cmH2O of positive end expiratory pressure (PEEP) aiming to get an SpO2>95%. Tidal volume and respiratory rate were set as to maintain a PetCO2 between 30 and 45 mmHg. A nasogastric tube was inserted before trocars introduction (T0). Patients from the two study groups had a postoperative analgesia prescription including acetaminophen (1g/6h), Ketoprofen (100 mg/12h) and Nefopam (20mg/4h). A 5 mg subcutaneous morphine injection was considered as rescue analgesia.
- Conditions
- Neuromuscular Blockade, Regional Anesthesia
- Being tested
- Bilateral ultrasound guided TAP bloc, Neuromuscular blockade agent: Atracurium 01mg/kg per bolus
- Keywords
- TAP block, curare, laparoscopy, gynecology surgery, abdominal compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ultrasound guided TAP blocProcedure or surgery
In the TAP group: Bilateral ultrasound guided TAP bloc for laparoscopic gynecologic surgery
Neuromuscular blockade agent: Atracurium 01mg/kg per bolusDrug
In the TRAC group: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus for maintaining muscular relaxation and immobilization during laparoscopic gynecologic surgery
| Study group | Role | What they receive |
|---|---|---|
| TAP Group | Experimental | Bilateral ultrasound TAP bloc performed via 20 ml of 2.5% bupivacaine without neuromuscular blocking agents Receives: Procedure: Bilateral ultrasound guided TAP bloc |
| TRAC Group | Active comparator | Neuromuscular blocking agent: Atracurium 0.1 mg/kg per bolus Receives: Drug: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal compliance (Ca)
Ca calculation was based on the formula: Ca= ΔV/ΔP with ΔV and ΔP referring to the volume variation of CO2 insufflated and ΔP to the variation of intraabdominal pressure during the procedure
Measured: peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal
surgeon satisfaction
Surgeons were asked at the end of the procedure about their satisfaction. Their answers were put on a scale between 1 and 4 (1: poor, 2: average, 3: good, 4: excellent)
Measured: peroperatively
Secondary outcomes (8)
Heart Rate (HR) (bpm)
Heart rate
Measured: peropertively from the laparoscopy trocars introduction until skin closure
Mean arterial pressure (MAP) (mmHg)
Mean arterial pressure
Measured: peropertively from the laparoscopy trocars introduction until skin closure
SpO2 (%)
pulsed oxygen saturation
Measured: peropertively from the laparoscopy trocars introduction until skin closure
PetCO2 (mmHg)
End Tidal CO2 pressure
Measured: peropertively from the laparoscopy trocars introduction until skin closure
Pp (cmH2O)
Plateau pressure
Measured: peopertively from the laparoscopy trocars introduction until skin closure
awakening time after disruption/discontinuing analgesia
time needed for extubation after discontinuing anesthesia maintenance
Measured: peropertaively
diaphgram mouvement
diphgram mouvement assessed on the ventilator or in the laparoscopy monitor
Measured: peropertively
surgeons complaint
surgeons complaints about operation conditions
Measured: peropertaively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Feb 2015
- Primary completion31 Jul 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen Maghrebi, Professor, Study chair, Tunis Maternity Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701256
- Sponsor's protocol ID
- TAP-TRAC
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures. Do we Really Still Need the Systemic Neuromuscular Blocking Agents?
- ClinicalTrials.gov ID
- NCT03701256
- Acronym / sponsor ID
- TAP-TRAC
- Conditions
- Neuromuscular Blockade, Regional Anesthesia
- Keywords
- TAP block, curare, laparoscopy, gynecology surgery, abdominal compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 9 Oct 2018 (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.
A monocentric, prospective, randomized controlled trial, including patients proposed for a laparoscopic gynecologic surgery comparing the muscular relaxing effect of a bilateral ultrasound-guided Transversus Abdominis Plane block to usual neuromuscular blockade agent (Atracurium)
Detailed description
We conducted a monocentric randomized single blinded controlled trial for six months starting from February 2015 until July 2015. Patients undergoing laparoscopic gynecologic procedures were included and randomly assigned in two groups receiving either an ultrasound guided TAP block (TAP group) or usual Neuromuscular blockade curare type: Atracurium (TRAC group). Randomization was simple and the allocation sequence was generated by a random number table via computer. The surgeon in charge was blinded about the performance of a TAP block.
Anesthesia protocol was almost the same in the two groups apart from the TAP block performance in the study group and the use of the neuromuscular blockade . No premedication was given to before the procedure. Monitoring was standard with a 5 leads electrocardioscope, non-invasive arterial pressure, pulsed oximetry (SpO2) and pressure of end tidal expired CO2 (PetCO2). Peripheral venous access was obtained and a 0.9 % saline vascular prefilling was done via an 18 or a 16 Gauges (G) percutaneous line in the non-dominant superior member. In the TRAC group, induction was given with 2.5 mg Propofol, 3 γ/kg Fentanyl and 0.6 mg/kg Atracurium. In The TAP group general anesthesia was induced, after a 3 minutes pre-oxygenation, with 3 γ/kg fentanyl, 2.5 mg/kg Propofol and 1mg/kg Suxamethonium. Thereafter the TAP block was performed under ultrasonography guidance with a Samsung (MySonoU6) transportable device and a linear high frequency 5-12 Megahertz transducer. The probe was oriented transversely on the antero-lateral abdominal wall and the image depth was set between 4 and 6 cm. Once anatomic structures were visualized and well distinct, the probe was moved posteriorly until the mid-axillary line between the 12th rib and the iliac crest. Operator should be able to identify from top to bottom: the subcutaneous fat tissue (hypo-echogenic), External Oblic Abdominal Muscle (EOAM), Internal Oblic Abdominal Muscle (IOAM), Transverse Abdominis Muscle (TAM) (heterogeneous), peritoneum (hyper-echogenic) and underneath intraabdominal organs both moving with respiration. The junction between the posterior fascia of the IOAM and the anterior fascia of the TAM is also hyper-echogenic and represent the region of interest as it is the local anesthetic injection site. The puncture was proceeded with 100 mm lenght needle 21 G (Vygon, France) needle witch progressed obliquely through the abdominal wall. Operator realized an in plane ultrasound guided approach. As soon as the tip of the needle was placed in the junction between the IOAM and TAM and the aspiration test negative, a priming of 3 ml local anesthetic injection was used in order to unsure a correct position of the needle. In this case the injectate would appear as a hypo-echogenic oval well-shaped volume spreading between the two muscle layers. An inaccurate injection was suspected by the absence of the described image. Intramuscular injection could appear as a poorly defined hyper-echogenic image within the muscle. Once the correct position verified, the rest of the 20 ml of the 2.5% bupivacaine is injected. The contralateral block was performed equally. Anesthesia was maintained by a total intravenous anesthesia in both groups. Fentanyl was systematically reinjected every 30 minutes and Propofol was infused at 8-10 mg/kg/h. In the TRAC group, Atracurium reinjections were guided by the monitoring of the NMB every 20 minute at a dose equal to 0.1mg/kg to be reevaluated after 5 minutes. In the TAP group, a rescue injection of NMB agent was indicated in case of diaphragmatic contractions, surgeons' complaint or patients' movement after optimization of narcosis by increasing propofol infusing speed to a maximum of 5 mg/kg/h beyond the baseline speed and checking analgesia. In both groups patients were ventilated on a volume assisted mode with 50 % of inspired fraction of Oxygen and 4-6 cmH2O of positive end expiratory pressure (PEEP) aiming to get an SpO2>95%. Tidal volume and respiratory rate were set as to maintain a PetCO2 between 30 and 45 mmHg. A nasogastric tube was inserted before trocars introduction (T0). Patients from the two study groups had a postoperative analgesia prescription including acetaminophen (1g/6h), Ketoprofen (100 mg/12h) and Nefopam (20mg/4h). A 5 mg subcutaneous morphine injection was considered as rescue analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Group | Experimental | Procedure: Bilateral ultrasound guided TAP blocBilateral ultrasound TAP bloc performed via 20 ml of 2.5% bupivacaine without neuromuscular blocking agents |
| TRAC Group | Active comparator | Drug: Neuromuscular blockade agent: Atracurium 01mg/kg per bolusNeuromuscular blocking agent: Atracurium 0.1 mg/kg per bolus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- American Association of anesthesiologists' class I to III (ASA I to ASA III)
- undergoing laparoscopic gynecologic procedures
- patients' refusal to be part of the study
- ASA IV and higher
- known allergic history to Propofol or any of its components (eggs, soya and beans, etc.), suxamethonium, Fentanyl or Atracurium.
Key exclusion criteria (2 listed)
- unsuccessful TAP block
- Observed anesthesia or surgical incident which requires the end of the ongoing procedure or the conversion to laparotomy
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 |
|---|---|---|
| Bilateral ultrasound guided TAP blocIn the TAP group: Bilateral ultrasound guided TAP bloc for laparoscopic gynecologic surgery | Procedure or surgery | TAP Group |
| Neuromuscular blockade agent: Atracurium 01mg/kg per bolusIn the TRAC group: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus for maintaining muscular relaxation and immobilization during laparoscopic gynecologic surgery | Drug | TRAC Group |
Primary outcome
Abdominal compliance (Ca)
Time frame: peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal
Ca calculation was based on the formula: Ca= ΔV/ΔP with ΔV and ΔP referring to the volume variation of CO2 insufflated and ΔP to the variation of intraabdominal pressure during the procedure
surgeon satisfaction
Time frame: peroperatively
Surgeons were asked at the end of the procedure about their satisfaction. Their answers were put on a scale between 1 and 4 (1: poor, 2: average, 3: good, 4: excellent)
8 secondary outcomes
Heart Rate (HR) (bpm)
Time frame: peropertively from the laparoscopy trocars introduction until skin closure
Mean arterial pressure (MAP) (mmHg)
Time frame: peropertively from the laparoscopy trocars introduction until skin closure
SpO2 (%)
Time frame: peropertively from the laparoscopy trocars introduction until skin closure
PetCO2 (mmHg)
Time frame: peropertively from the laparoscopy trocars introduction until skin closure
Pp (cmH2O)
Time frame: peopertively from the laparoscopy trocars introduction until skin closure
awakening time after disruption/discontinuing analgesia
Time frame: peropertaively
diaphgram mouvement
Time frame: peropertively
surgeons complaint
Time frame: peropertaively
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 17 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hayen Maghrebi, Professor study chair
Tunis Maternity Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus in people with Neuromuscular Blockade and Regional Anesthesia, run by University Tunis El Manar 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 8 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: finished, as of the sponsor's last update on 17 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Abdominal compliance (Ca) (time frame: peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal). The study lists 2 primary outcomes in all. 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 17 Oct 2018.