Postoperative PainNCT05398406
Subcostal Transversus Abdominus , Erector Spinae and Paravertebral Blocks Effects on Laparoscopic Cholecystectomy Cases
A study testing Subcostal TAP Block, ESP Block and Paravertebral Block in people with Postoperative Pain, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block group (Group E) and PVB group (Group P). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Subcostal TAP Block, ESP Block and Paravertebral Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jan 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-60 years,
- ASA I-II ,
- scheduled for elective laparoscopic cholecystectomy
- under general anesthesia,
- agreed to participate in the study,
Who cannot join
- under the age of 20 - over 60,
- emerge and bleeding,
- outside the ASAI-II functional status,
- undergo surgery other than laparoscopic cholecystectomy,
- refused to participate in the study, allergic to local anesthetic agents,
- body mass index (BMI) >30,
- have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia),
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subcostal Transversus Abdominus Plane Block, Erector Spinae Plane Block and Paravertebral Blocks Effects
Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block group (Group E) and PVB group (Group P). Bilateral 20cc (total 40cc for each patient) 0.25% bupivacaine was applied by ultrasound (US) guidance. Intraoperative vital signs (heart rate, blood pressure, and saturation), Train-of-four (TOF) values, additional dose of opioid and muscle relaxant needs, complications were recorded. Postoperative side effects (nausea, vomiting, itching, tremor), the need for additional postoperative analgesia, Visual Analog Scale (VAS) scores were noted.
Read the detailed description
Cases; under the age of 20 - over 60, emerge and bleeding, outside the ASA physical status other than I-II, undergo surgery other than laparoscopic cholecystectomy, refused to participate in the study, allergic to local anesthetic agents, with a body mass index (BMI) >30, have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia), pregnant were not included in the study.Twenty patients in each group and a total of 60 patients were included the study by power analysis. Patients were randomly allocated to three groups using a concealed-envelope allocation method. Both participants and the postoperative outcome assessor were blinded to group allocation.
Group T (Subcostal TAP Block): 40 cc (20cc+20cc) 0.25 % Bupivacaine for bilateral application Group E (ESP Block): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application Group P (PVB): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application were prepared.
- Conditions
- Postoperative Pain
- Being tested
- Subcostal TAP Block, ESP Block, Paravertebral Block
- Keywords
- plane blocks, ultrasonography, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal TAP BlockOther
Bilateral ultrasound-guided subcostal transversus abdominis plane (TAP) block was performed after induction of general anesthesia. The ultrasound probe was positioned immediately inferior and parallel to the costal margin. After identification of the abdominal wall muscle layers, the needle was advanced under ultrasound guidance and local anesthetic was injected into the fascial plane between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side).
ESP BlockOther
Bilateral ultrasound-guided erector spinae plane (ESP) block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process and overlying erector spinae muscle were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane, and local anesthetic was injected into the fascial plane between the erector spinae muscle and the transverse process. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side).
Paravertebral BlockOther
Bilateral ultrasound-guided thoracic paravertebral block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process, superior costotransverse ligament, and pleura were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane into the thoracic paravertebral space. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side).
| Study group | Role | What they receive |
|---|---|---|
| Subcostal TAP Block | Experimental | Bilateral ultrasound-guided subcostal transversus abdominis plane (TAP) block was performed after induction of general anesthesia. The ultrasound probe was positioned immediately inferior and parallel to the costal margin. After identification of the abdominal wall muscle layers, the needle was advanced under ultrasound guidance and local anesthetic was injected into the fascial plane between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). Receives: Other: Subcostal TAP Block |
| ESP Block | Experimental | Bilateral ultrasound-guided erector spinae plane (ESP) block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process and overlying erector spinae muscle were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane, and local anesthetic was injected into the fascial plane between the erector spinae muscle and the transverse process. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). Receives: Other: ESP Block |
| Paravertebral block | Experimental | In the lateral decubitus position, the cranial to caudal transverse processes and the superior costotransverse ligament and the pleura were visualized from the T7-8 level in the in-plane section under US guidance. A 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®, USA) was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made bilaterally in the form of 20+20 ml. Receives: Other: Paravertebral Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity at 6 hours measured by 10-cm Visual Analogue Scale (VAS)
Pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 6 hours postoperatively
Secondary outcomes (5)
Postoperative rescue analgesic requirement
Rescue analgesia was indicated for a VAS score >5 and consisted of intravenous dexketoprofen 50 mg. No patient required rescue analgesia before the 6-hour postoperative VAS assessment; therefore, no rescue analgesic was administered during this period.
Measured: During the postoperative follow-up period, including assessment at 6 hours.
Intraoperative opioid consumption
Total intraoperative supplemental fentanyl requirement administered in response to hemodynamic changes.
Measured: During surgery
Intraoperative neuromuscular blocker requirement
Supplemental intraoperative rocuronium requirement based on train-of-four (TOF) monitoring.
Measured: During surgery
Incidence of postoperative adverse events
Incidence of postoperative nausea, vomiting, shivering, pruritus, and oxygen desaturation recorded during the early postoperative period.
Measured: Within the first 6 hours postoperatively
Time to first mobilization
Time from arrival in the recovery unit to first independent mobilization (standing or walking without assistance).
Measured: Within the first 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jan 2020
- Primary completion1 Aug 2020
- Study completion1 Jan 2021
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, participant- and outcome assessor-blinded study using a closed-envelope allocation method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Arzu E Tekeli, MD, Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398406
- Sponsor's protocol ID
- 01
- Status last verified
- Oct 2026
- First submitted
- 17 May 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcostal Transversus Abdominus Plane Block, Erector Spinae Plane Block and Paravertebral Blocks Effects
- ClinicalTrials.gov ID
- NCT05398406
- Acronym / sponsor ID
- 01
- Conditions
- Postoperative Pain
- Keywords
- plane blocks, ultrasonography, bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 1 Jun 2022 (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.
Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block group (Group E) and PVB group (Group P). Bilateral 20cc (total 40cc for each patient) 0.25% bupivacaine was applied by ultrasound (US) guidance. Intraoperative vital signs (heart rate, blood pressure, and saturation), Train-of-four (TOF) values, additional dose of opioid and muscle relaxant needs, complications were recorded. Postoperative side effects (nausea, vomiting, itching, tremor), the need for additional postoperative analgesia, Visual Analog Scale (VAS) scores were noted.
Detailed description
Cases; under the age of 20 - over 60, emerge and bleeding, outside the ASA physical status other than I-II, undergo surgery other than laparoscopic cholecystectomy, refused to participate in the study, allergic to local anesthetic agents, with a body mass index (BMI) >30, have contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart disease, hypovolemia, cases that do not want regional anesthesia), pregnant were not included in the study.Twenty patients in each group and a total of 60 patients were included the study by power analysis. Patients were randomly allocated to three groups using a concealed-envelope allocation method. Both participants and the postoperative outcome assessor were blinded to group allocation.
Group T (Subcostal TAP Block): 40 cc (20cc+20cc) 0.25 % Bupivacaine for bilateral application Group E (ESP Block): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application Group P (PVB): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application were prepared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, participant- and outcome assessor-blinded study using a closed-envelope allocation method.
| Arm | Type | Receives |
|---|---|---|
| Subcostal TAP Block | Experimental | Other: Subcostal TAP BlockBilateral ultrasound-guided subcostal transversus abdominis plane (TAP) block was performed after induction of general anesthesia. The ultrasound probe was positioned immediately inferior and parallel to the costal margin. After identification of the abdominal wall muscle layers, the needle was advanced under ultrasound guidance and local anesthetic was injected into the fascial plane between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). |
| ESP Block | Experimental | Other: ESP BlockBilateral ultrasound-guided erector spinae plane (ESP) block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process and overlying erector spinae muscle were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane, and local anesthetic was injected into the fascial plane between the erector spinae muscle and the transverse process. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). |
| Paravertebral block | Experimental | Other: Paravertebral BlockIn the lateral decubitus position, the cranial to caudal transverse processes and the superior costotransverse ligament and the pleura were visualized from the T7-8 level in the in-plane section under US guidance. A 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®, USA) was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made bilaterally in the form of 20+20 ml. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20-60 years,
- ASA I-II ,
- scheduled for elective laparoscopic cholecystectomy
- under general anesthesia,
- agreed to participate in the study,
Key exclusion criteria (8 listed)
- under the age of 20 - over 60,
- emerge and bleeding,
- outside the ASAI-II functional status,
- undergo surgery other than laparoscopic cholecystectomy,
- refused to participate in the study, allergic to local anesthetic agents,
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 |
|---|---|---|
| Subcostal TAP BlockBilateral ultrasound-guided subcostal transversus abdominis plane (TAP) block was performed after induction of general anesthesia. The ultrasound probe was positioned immediately inferior and parallel to the costal margin. After identification of the abdominal wall muscle layers, the needle was advanced under ultrasound guidance and local anesthetic was injected into the fascial plane between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). | Other | Subcostal TAP Block |
| ESP BlockBilateral ultrasound-guided erector spinae plane (ESP) block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process and overlying erector spinae muscle were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane, and local anesthetic was injected into the fascial plane between the erector spinae muscle and the transverse process. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). | Other | ESP Block |
| Paravertebral BlockBilateral ultrasound-guided thoracic paravertebral block was performed after induction of general anesthesia. At the T7-T8 vertebral level, the transverse process, superior costotransverse ligament, and pleura were identified under ultrasound guidance. A 21-G, 100-mm block needle was advanced in-plane into the thoracic paravertebral space. A total of 40 mL of 0.25% bupivacaine was administered bilaterally (20 mL on each side). | Other | Paravertebral block |
Primary outcome
Postoperative pain intensity at 6 hours measured by 10-cm Visual Analogue Scale (VAS)
Time frame: 6 hours postoperatively
Pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
5 secondary outcomes
Postoperative rescue analgesic requirement
Time frame: During the postoperative follow-up period, including assessment at 6 hours.
Intraoperative opioid consumption
Time frame: During surgery
Intraoperative neuromuscular blocker requirement
Time frame: During surgery
Incidence of postoperative adverse events
Time frame: Within the first 6 hours postoperatively
Time to first mobilization
Time frame: Within the first 6 hours postoperatively
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 21 Oct 2026.
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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.
Arzu E Tekeli, MD principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal TAP Block, ESP Block and Paravertebral Block in people with Postoperative Pain, run by Yuzuncu Yil 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 5 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 21 Oct 2026. 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?
Postoperative pain intensity at 6 hours measured by 10-cm Visual Analogue Scale (VAS) (time frame: 6 hours postoperatively). 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 21 Oct 2026.