Postoperative PainNCT05901090
Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH
A study testing M-TAPA block and TAP block in people with Postoperative Pain, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- M-TAPA block and TAP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2023to 1 Jun 2023
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients older than 35 years of age who underwent open total abdominal hysterectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Who cannot join
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients undergoing laparoscopic surgery,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Transerversus Abdominis Plane Block (TAP) on Postoperative Pain Scores and Total Analgesic Consumption in Patients Ongoing Total Abdominal Hysterectomy
Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.
Read the detailed description
There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15) and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated.
- Conditions
- Postoperative Pain
- Being tested
- M-TAPA block, TAP block
- Keywords
- m-tapa, tap block, total abdominal hysterectomy, regional anesthesia, postoperative pain
- 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 blockOther
Also called Modified thoracoabdominal nerve block through perichondrial approach
Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose was applied to the contralateral side for each group of M-TAPA patients.
TAP blockOther
Also called Transversus abdominis plane block
After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were identified. As the tip of the 80 mm sonovisible needle passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), the location of the needle was fixed and frequently aspirated and applied to the plane so that 20 ml of 0.25% bupivacaine was applied to each side. (40 ml in total)
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA block | Active comparator | Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control. Receives: Other: M-TAPA block |
| TAP block | Active comparator | Patients had bilateral TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control. Receives: Other: TAP block |
| Control | No intervention | Control group patients were not subjected to any block or local infiltration anesthesia. Their postoperative pain was relieved with tramadol (intravenous) administration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the numerical rating scale scores
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Comparing total tramadol consumption
Postoperative analgesic need
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 posted13 Jun 2023
- Study start12 Apr 2023
- Primary completion25 May 2023
- Study completion1 Jun 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901090
- Sponsor's protocol ID
- M-TAPA vs TAP block on TAH
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Transerversus Abdominis Plane Block (TAP) on Postoperative Pain Scores and Total Analgesic Consumption in Patients Ongoing Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT05901090
- Acronym / sponsor ID
- M-TAPA vs TAP block on TAH
- Conditions
- Postoperative Pain
- Keywords
- m-tapa, tap block, total abdominal hysterectomy, regional anesthesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 13 Jun 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.
Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.
Detailed description
There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15) and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M-TAPA block | Active comparator | Other: M-TAPA blockPatients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control. |
| TAP block | Active comparator | Other: TAP blockPatients had bilateral TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control. |
| Control | No intervention | –Control group patients were not subjected to any block or local infiltration anesthesia. Their postoperative pain was relieved with tramadol (intravenous) administration. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients older than 35 years of age who underwent open total abdominal hysterectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Key exclusion criteria (8 listed)
- Patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 blockAlso: Modified thoracoabdominal nerve block through perichondrial approachFollowing sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose was applied to the contralateral side for each group of M-TAPA patients. | Other | M-TAPA block |
| TAP blockAlso: Transversus abdominis plane blockAfter the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were identified. As the tip of the 80 mm sonovisible needle passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), the location of the needle was fixed and frequently aspirated and applied to the plane so that 20 ml of 0.25% bupivacaine was applied to each side. (40 ml in total) | Other | TAP block |
Primary outcome
Comparing the numerical rating scale scores
Time frame: Postoperative 24 hours
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
1 secondary outcome
Comparing total tramadol consumption
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 13 Jun 2023.
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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.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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 and TAP block in people with Postoperative Pain, run by Cumhuriyet University 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 1 inclusion and 8 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 13 Jun 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 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?
Comparing the numerical rating scale scores (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 13 Jun 2023.