Postoperative PainNCT06008002
Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy
A study testing M-TAPA block, EXORA block and Tramadol in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Laparoscopic Cholecystectomy, Regional Anesthesia
- What is being tested?
- M-TAPA block, EXORA block and Tramadol
- 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 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2023to 13 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laparoscopic cholecystectomy surgery
- Patients with ASA (American Society of Anaesthetists) scores I and III will be included.
Who cannot join
- Uncontrolled Arterial Hypertension
- Uncontrolled Diabetes Mellitus,
- Mental retardation ,
- Antidepressant use
- Metabolic disorders,
- Bleeding diathesis
- Patients with a body mass index above 30.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study
Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.
- Being tested
- M-TAPA block, EXORA block, Tramadol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPA blockProcedure or surgery
ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed
EXORA blockProcedure or surgery
Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
TramadolDrug
400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block Receives: Procedure: M-TAPA block; Drug: Tramadol |
| Group E | Active comparator | Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block Receives: Procedure: EXORA block; Drug: Tramadol |
| Group P | Active comparator | Patient-controlled analgesia with tramadol Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: Postoperative 24 hours
Secondary outcomes (5)
tramadol consumption
Measured: Postoperative 24 hours
side effect profile scores
- Nausea and vomiting scale (nausea-vomiting scale (NVS):
- No nausea is present,
- Mild nausea is present.
- Severe nausea is present.
- Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
Measured: Postoperative 24 hours
additional analgesic use
additional analgesic use
Measured: Postoperative 24 hours
pinprick test
The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.
With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.
Measured: Postoperative 24 hours
Ramsay Sedation Scale
Ramsay Sedation Scale (RSS) :
- Anxiety, agitation are present;
- Cooperated,awake;
- Sedated , response to commands;
- Sleepy, immediately awoken by auditory stimulus or glabella tap;
- Sleepy, deep response to auditory stimulus or glabella tap and
- Sleepy, no response to auditory stimulus or glabella tap )
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start25 Aug 2023
- Primary completion25 Dec 2023
- Study completion13 Jan 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-blind, observational study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008002
- Sponsor's protocol ID
- 2023-3/1
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2023
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study
- ClinicalTrials.gov ID
- NCT06008002
- Acronym / sponsor ID
- 2023-3/1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 23 Aug 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.
Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.
Detailed description
In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, single-blind, observational study
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Procedure: M-TAPA block, Drug: Tramadolultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block |
| Group E | Active comparator | Procedure: EXORA block, Drug: TramadolUltrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block |
| Group P | Active comparator | Drug: TramadolPatient-controlled analgesia with tramadol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- laparoscopic cholecystectomy surgery
- Patients with ASA (American Society of Anaesthetists) scores I and III will be included.
Key exclusion criteria (7 listed)
- Uncontrolled Arterial Hypertension
- Uncontrolled Diabetes Mellitus,
- Mental retardation ,
- Antidepressant use
- Metabolic disorders,
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 |
|---|---|---|
| M-TAPA blockultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed | Procedure or surgery | Group M |
| EXORA blockUltrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed | Procedure or surgery | Group E |
| Tramadol400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. | Drug | Group E, Group M, Group P |
Primary outcome
NRS
Time frame: Postoperative 24 hours
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
5 secondary outcomes
tramadol consumption
Time frame: Postoperative 24 hours
side effect profile scores
Time frame: Postoperative 24 hours
additional analgesic use
Time frame: Postoperative 24 hours
pinprick test
Time frame: Postoperative 24 hours
Ramsay Sedation Scale
Time frame: Postoperative 24 hours
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 12 Aug 2024.
- 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.
Korgün Ökmen principal investigator
Bursa Yuksek Ihtisas Training and Research 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 M-TAPA block, EXORA block and Tramadol in people with Postoperative Pain and Laparoscopic Cholecystectomy, run by Bursa Yuksek Ihtisas 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 2 inclusion and 7 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 12 Aug 2024. 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?
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?
NRS (time frame: Postoperative 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 12 Aug 2024.