Postoperative PainNCT04875598
COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
A study testing Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block in people with Postoperative Pain and Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 people. Today, the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia, Transversus Abdominis Plane Block
- What is being tested?
- Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Mar 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- Patients who underwent total extraperitoneal hernia repair
- Patients without any postoperative complications
- Patients who cannot be drained for any reason
Who cannot join
- Patients who underwent another hernia repair technique during surgery for any reason.
- Patients who do not want to participate in the study
- Patients with any complications after surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih sultan mehmet training and research hospital
Istanbul, 34734
Anıl Ergin
About this study
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 people. Today, the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated. Laparoscopic approach offers many advantages over open repair. Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain. In this sense, the Transversus Abdominis Plane Block (TAPB) emerges as an effective regional anesthesia method that reduces postoperative pain. This method can be applied with the help of ultrasound or laparoscopy. The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair (TEP) to reveal the effects of postoperative pain.
A total of 60 patients will be included in the study; 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPB with 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography); In the other 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 50 mg intravenous tramadol will be administered to patients with VAS > 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes. Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour. Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic. The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
Read the detailed description
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 people. Today, the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated. Laparoscopic approach offers many advantages over open repair. These are topics such as postoperative pain, quick recovery, and shortening of returning to work. Postoperative pain is the most important determinant of recovery after abdominal surgeries. Postoperative pain can be explained by two pathways connected to the peritoneum; The first is the parietal peritoneum, which has a very rich innervation, and the other is the visceral peritoneum stimulated by the vagus. In order to eliminate these peritoneal pains, surgeons have been injecting local anesthetic into various areas on the anterior abdominal wall and intraperitoneal space since 1950. Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain. In this sense, the Transversus Abdominis Plane Block (TAPB) emerges as an effective regional anesthesia method that reduces postoperative pain. TAPB; It is a type of regional anesthesia applied to the facial plane between the internal oblique muscle and the transversus abdominis muscles, targeting the somatic nerves (T6 - L1). This method can be applied with the help of ultrasound or laparoscopy. The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair (TEP) to reveal the effects of postoperative pain.
TEP will be performed with 2-3 mg / kg propofol, 2 mcg / kg fentanyl and 0.6 mg / kg rocuronium in patients who will undergo anesthesia induction with BIS < 60, after intubation, 40 % oxygen / 1.5 - 2 % sevoflurane inhalation will be applied to keep the BIS value between 40 - 60 in 60 % air. Before the operation starts, TAPB will be made with 20 ml 0.25 % bupivacaine in the direction of ultrasonography on the side to be operated. During the operation, if there is a 20 % increase in blood pressure and heart rate from baseline, 0.5 mcg / kg intravenous fentanyl will be administered and the administered fentanyl dose will be recorded. 1gr paracetamol 30 minutes before the end of the operation and 4 mg ondansetron 15 minutes before the end of the operation will be administered intravenously. With the help of a 22 G injector, local anesthetic injection will be made from the anterior to the area where the midaxillary line intersects the Bogros area. Digital examination will be performed to define the injection site and the injection area will be determined.
A total of 60 patients will be included in the study; 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPB with 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography); In the other 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups. Bart 3D anatomical polypropylene patch will be used in both groups and the patch will be attached with the help of 1 absorbable tacker. Carbon dioxide gas will be given to the preperitoneal area at a rate of 4 - 6 L / min and at a pressure of 15 mm Hg. 3 trocars will be used; One 10 mm camera trocar and two 5 mm working trocars will be entered through the midline below the navel. At the end of the operation, the patients will be extubated by antagonizing the muscle relaxant effect with 0.02 mg / kg atropine and 0.05 mg / kg neostigmine. 10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 50 mg intravenous tramadol will be administered to patients with VAS > 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes. Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour. Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic. The doses of analgesic administered in the postoperative period and the hours of administration will be recorded.
- Being tested
- Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block
- Keywords
- inguinal hernia, Transversus abdominis plane block, postoperative pain, Total extraperitoneal hernia repair
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane BlockProcedure or surgery
Ultrasound assisted TAPB application will be applied by an anesthesiology and reanimation specialist and Laparoscopy assisted TAPB application will be applied by the surgeon performing the operation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 30 patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography) Receives: Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block |
| Group 2 | Active comparator | 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups. Receives: Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 10: too much pain , 1: no pain
Measured: 24 hours
Secondary outcomes (1)
patient satisfaction
Patients will be evaluated with a patient satisfaction questionnaire after surgery. 5: Very satisfied , 1:Not satisfied
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A total of 60 patients will be included in the study; Group 1: 30 patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography) Group 2: 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875598
- Sponsor's protocol ID
- drANILERGIN
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 6 May 2021
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
- ClinicalTrials.gov ID
- NCT04875598
- Acronym / sponsor ID
- drANILERGIN
- Keywords
- inguinal hernia, Transversus abdominis plane block, postoperative pain, Total extraperitoneal hernia repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 6 May 2021 (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.
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 people. Today, the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated. Laparoscopic approach offers many advantages over open repair. Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain. In this sense, the Transversus Abdominis Plane Block (TAPB) emerges as an effective regional anesthesia method that reduces postoperative pain. This method can be applied with the help of ultrasound or laparoscopy. The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair (TEP) to reveal the effects of postoperative pain.
A total of 60 patients will be included in the study; 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPB with 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography); In the other 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 50 mg intravenous tramadol will be administered to patients with VAS > 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes. Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour. Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic. The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
Detailed description
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 people. Today, the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated. Laparoscopic approach offers many advantages over open repair. These are topics such as postoperative pain, quick recovery, and shortening of returning to work. Postoperative pain is the most important determinant of recovery after abdominal surgeries. Postoperative pain can be explained by two pathways connected to the peritoneum; The first is the parietal peritoneum, which has a very rich innervation, and the other is the visceral peritoneum stimulated by the vagus. In order to eliminate these peritoneal pains, surgeons have been injecting local anesthetic into various areas on the anterior abdominal wall and intraperitoneal space since 1950. Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain. In this sense, the Transversus Abdominis Plane Block (TAPB) emerges as an effective regional anesthesia method that reduces postoperative pain. TAPB; It is a type of regional anesthesia applied to the facial plane between the internal oblique muscle and the transversus abdominis muscles, targeting the somatic nerves (T6 - L1). This method can be applied with the help of ultrasound or laparoscopy. The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair (TEP) to reveal the effects of postoperative pain.
TEP will be performed with 2-3 mg / kg propofol, 2 mcg / kg fentanyl and 0.6 mg / kg rocuronium in patients who will undergo anesthesia induction with BIS < 60, after intubation, 40 % oxygen / 1.5 - 2 % sevoflurane inhalation will be applied to keep the BIS value between 40 - 60 in 60 % air. Before the operation starts, TAPB will be made with 20 ml 0.25 % bupivacaine in the direction of ultrasonography on the side to be operated. During the operation, if there is a 20 % increase in blood pressure and heart rate from baseline, 0.5 mcg / kg intravenous fentanyl will be administered and the administered fentanyl dose will be recorded. 1gr paracetamol 30 minutes before the end of the operation and 4 mg ondansetron 15 minutes before the end of the operation will be administered intravenously. With the help of a 22 G injector, local anesthetic injection will be made from the anterior to the area where the midaxillary line intersects the Bogros area. Digital examination will be performed to define the injection site and the injection area will be determined.
A total of 60 patients will be included in the study; 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPB with 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography); In the other 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups. Bart 3D anatomical polypropylene patch will be used in both groups and the patch will be attached with the help of 1 absorbable tacker. Carbon dioxide gas will be given to the preperitoneal area at a rate of 4 - 6 L / min and at a pressure of 15 mm Hg. 3 trocars will be used; One 10 mm camera trocar and two 5 mm working trocars will be entered through the midline below the navel. At the end of the operation, the patients will be extubated by antagonizing the muscle relaxant effect with 0.02 mg / kg atropine and 0.05 mg / kg neostigmine. 10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 50 mg intravenous tramadol will be administered to patients with VAS > 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes. Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour. Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic. The doses of analgesic administered in the postoperative period and the hours of administration will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 60 patients will be included in the study; Group 1: 30 patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography) Group 2: 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block30 patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area (Before the operation starts, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography) |
| Group 2 | Active comparator | Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18
- Patients who underwent total extraperitoneal hernia repair
- Patients without any postoperative complications
- Patients who cannot be drained for any reason
Key exclusion criteria (3 listed)
- Patients who underwent another hernia repair technique during surgery for any reason.
- Patients who do not want to participate in the study
- Patients with any complications after surgery
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 |
|---|---|---|
| Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane BlockUltrasound assisted TAPB application will be applied by an anesthesiology and reanimation specialist and Laparoscopy assisted TAPB application will be applied by the surgeon performing the operation. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Postoperative pain
Time frame: 24 hours
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 10: too much pain , 1: no pain
1 secondary outcome
patient satisfaction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block in people with Postoperative Pain and Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 6 May 2021. 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 Turkey (Türkiye). 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 Anıl Ergin (+905342245366, dranilergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24 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 6 May 2021.