Pain, Acute PostoperativeNCT07149584
Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy
A study testing ESPB, TPVB and IV in people with Pain, Acute Postoperative, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute Postoperative
- What is being tested?
- ESPB, TPVB and IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 23 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cholecystectomy
- Age >18years
- American Society of Anesthesiologists classification I-III
Who cannot join
- Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
- Chronic analgesic use
- Open cholecystectomy or conversion to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy: A Randomized Controlled Trial on Opioid Consumption
The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.
Read the detailed description
All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam.
All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
- Conditions
- Pain, Acute Postoperative
- Being tested
- ESPB, TPVB, IV
- Keywords
- postoperative pain, erector spinal plane block, thoracic paravertebral block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBProcedure or surgery
10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia.
TPVBProcedure or surgery
10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura.
IVProcedure or surgery
Tramadol is administered via intravenous patient-controlled analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ESPB | Experimental | Erector spinal plane block Receives: Procedure: ESPB |
| Group 2: TPVB | Experimental | Thoracic paravertebral block Receives: Procedure: TPVB |
| Group 3: IV | Experimental | intravenous analgesia Receives: Procedure: IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tramadol consumption
amount of postoperative 24-hour tramadol consumption
Measured: postoperative 24 hours
Secondary outcomes (8)
Amount of fentanyl
Amount of fentanyl used intraoperatively
Measured: during surgery
Static and dynamic pain score
Static and dynamic pain scores are assessed with numeric rating scale at 0., 1., 4., 6., 12., 18. and 24. hours.
Measured: postoperative 24 hours
First rescue analgesic time
The first time patient required rescue analgesic.
Measured: postoperative 24 hours
Number of patients required rescue analgesic.
If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
Measured: postoperative 24 hours
Nausea and vomiting
Number of patients experienced postoperative nausea and vomiting
Measured: postoperative 24 hours
Complications
Number of patients experienced complications postoperatively
Measured: postoperative 24 hours
Quality of recovery
Patient recovery quality is evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
Measured: postoperative 24 hours
Length of hospital stay
Length of hospital stay
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Acute PostoperativeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Turhan, Istanbul University
- Investigators
- Özlem Turhan, Principal investigator, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149584
- Sponsor's protocol ID
- 2025/1127
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2025
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy: A Randomized Controlled Trial on Opioid Consumption
- ClinicalTrials.gov ID
- NCT07149584
- Acronym / sponsor ID
- 2025/1127
- Conditions
- Pain, Acute Postoperative
- Keywords
- postoperative pain, erector spinal plane block, thoracic paravertebral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 2 Sep 2025 (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.
The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.
Detailed description
All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam.
All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: ESPB | Experimental | Procedure: ESPBErector spinal plane block |
| Group 2: TPVB | Experimental | Procedure: TPVBThoracic paravertebral block |
| Group 3: IV | Experimental | Procedure: IVintravenous analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective cholecystectomy
- Age >18years
- American Society of Anesthesiologists classification I-III
Key exclusion criteria (3 listed)
- Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
- Chronic analgesic use
- Open cholecystectomy or conversion to open cholecystectomy
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 |
|---|---|---|
| ESPB10 mL of 0.375% bupivacaine is injected on each side between the deep fascia of the erector spinae muscle and the transverse process. Additionally, tramadol is administered via intravenous patient-controlled analgesia. | Procedure or surgery | Group 1: ESPB |
| TPVB10 mL of 0.375% bupivacaine is injected on each side between the superior costotransverse ligament and the pleura. | Procedure or surgery | Group 2: TPVB |
| IVTramadol is administered via intravenous patient-controlled analgesia. | Procedure or surgery | Group 3: IV |
Primary outcome
Tramadol consumption
Time frame: postoperative 24 hours
amount of postoperative 24-hour tramadol consumption
8 secondary outcomes
Amount of fentanyl
Time frame: during surgery
Static and dynamic pain score
Time frame: postoperative 24 hours
First rescue analgesic time
Time frame: postoperative 24 hours
Number of patients required rescue analgesic.
Time frame: postoperative 24 hours
Nausea and vomiting
Time frame: postoperative 24 hours
Complications
Time frame: postoperative 24 hours
Quality of recovery
Time frame: postoperative 24 hours
Length of hospital stay
Time frame: up to 1 week
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 2 Mar 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.
Özlem Turhan principal investigator
Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB, TPVB and IV in people with Pain, Acute Postoperative, run by Istanbul 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 3 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: finished, as of the sponsor's last update on 2 Mar 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?
Tramadol consumption (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 2 Mar 2026.