CholelithiasisTAP vs LAINCT07176299
Unilateral Laparoscopic TAP Block vs. Local Infiltration in Post-Cholecystectomy Analgesia
A study testing Unilateral laparoscopic TAP block (0.25% bupivacaine), Local anesthetic infiltration (0.25% bupivacaine) and Combined TAP block and local anesthetic infiltration (0.25% bupivacaine) in people with Cholelithiasis and Cholecystectomy, Laparoscopic, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
Trial summary
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cholelithiasis, Cholecystectomy, Laparoscopic, Pain, Postoperative
- What is being tested?
- Unilateral laparoscopic TAP block (0.25% bupivacaine), Local anesthetic infiltration (0.25% bupivacaine) and Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 14 Sep 2021to 30 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 85 years
- Scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis confirmed by ultrasonography
- American Society of Anesthesiologists (ASA) physical status I-II
- Provided written informed consent
Who cannot join
- ASA physical status III-IV
- Contraindications to laparoscopy
- Acute cholecystitis diagnosed preoperatively or perioperatively
- Chronic analgesic use
- Spinal degenerative joint disease
- Known allergy to local anesthetics
Show all 9Show fewer
- Opioid or alcohol dependence
- Psychiatric or neurological disorders
- Lack of consent or withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
University Clinical Hospital in Olsztyn
Olsztyn, Warmian-Masurian Voivodeship, 11-041
About this study
Official title: Efficacy of Unilateral Laparoscopic Transversus Abdominis Plane Block Compared to Local Infiltration in Postoperative Analgesia Following Laparoscopic Cholecystectomy
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.
Read the detailed description
Gallbladder stones are a common condition, and laparoscopic cholecystectomy is the standard treatment. Effective pain control after surgery is important for recovery and patient comfort. Traditionally, local anesthetic infiltration (LAI) at the surgical wound sites is used. Another method, the transversus abdominis plane (TAP) block, may provide better pain relief.
This prospective, randomized clinical trial was conducted at the University Clinical Hospital in Olsztyn, Poland. A total of 160 patients undergoing elective laparoscopic cholecystectomy were randomized into four groups: TAP block, LAI, TAP+LAI, and control. All patients received the same type of anesthesia and standard pain medications.
The primary goal was to compare pain intensity within 24 hours after surgery using the Numerical Rating Scale (NRS). Secondary measures included use of additional painkillers, recovery scores (Aldrete), and possible complications at the wound site. The influence of surgical drains and gallstone size on pain was also examined.
The study found that the unilateral laparoscopic TAP block provided the best pain relief, fewer wound-related complications, and reduced need for additional medications compared with other methods. These results suggest that the laparoscopic TAP block is a safe and effective option for improving postoperative pain management after gallbladder surgery.
- Conditions
- Cholelithiasis, Cholecystectomy, Laparoscopic, Pain, Postoperative, Anesthesia, Local, Nerve Block
- Being tested
- Unilateral laparoscopic TAP block (0.25% bupivacaine), Local anesthetic infiltration (0.25% bupivacaine), Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)
- Keywords
- Laparoscopic cholecystectomy, unilateral transversus abdominis plane block, local anesthetic infiltration, postoperative pain management, regional anesthesia
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral laparoscopic TAP block (0.25% bupivacaine)Procedure or surgery
Injection of 20 mL 0.25% bupivacaine into the transversus abdominis plane under direct laparoscopic vision.
Local anesthetic infiltration (0.25% bupivacaine)Procedure or surgery
Injection of 20 mL 0.25% bupivacaine distributed across trocar insertion sites under laparoscopic guidance.
Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)Procedure or surgery
10 mL of 0.25% bupivacaine given as a TAP block and 10 mL administered as local infiltration at trocar sites.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block | Experimental | Participants received a unilateral laparoscopic transversus abdominis plane (TAP) block performed under direct laparoscopic vision using 20 mL of 0.25% bupivacaine. Receives: Procedure: Unilateral laparoscopic TAP block (0.25% bupivacaine) |
| Local Anesthetic Infiltration (LAI) | Active comparator | Participants received local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites under laparoscopic guidance. Receives: Procedure: Local anesthetic infiltration (0.25% bupivacaine) |
| TAP + LAI | Experimental | Participants received a combination of unilateral laparoscopic TAP block (10 mL of 0.25% bupivacaine) and local anesthetic infiltration at trocar sites (10 mL of 0.25% bupivacaine). Receives: Procedure: Combined TAP block and local anesthetic infiltration (0.25% bupivacaine) |
| Control (No Regional Anesthesia) | No intervention | Participants did not receive regional anesthesia. Postoperative pain management was provided only with standardized intravenous analgesics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy
Pain intensity was assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Scores were recorded by patients at rest at three time points after laparoscopic cholecystectomy: 2 hours, 6 hours, and 24 hours postoperatively. Pain was evaluated as an overall score and at specific surgical sites (umbilical, subcostal, and substernal wounds). Assessments were performed only when patients reached an adequate level of consciousness, verified by Aldrete score.
Measured: Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day.
Secondary outcomes (1)
Use of rescue analgesics (metamizole, paracetamol, oxycodone) within 24 hours after laparoscopic cholecystectomy
Rescue analgesic use was recorded for each participant during the first 24 hours after laparoscopic cholecystectomy. Medications included metamizole, paracetamol, and oxycodone, administered according to standardized postoperative pain protocols: metamizole at 6, 12, 18, and 24 hours unless NRS ≤1, paracetamol if NRS >4, and oxycodone if NRS >6. The number and percentage of patients requiring each medication at 6, 12, 18, and 24 hours postoperatively were analyzed.
Measured: Rescue analgesic use assessed at 6, 12, 18, and 24 hours after surgery during the first postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start14 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: 1. unilateral laparoscopic TAP block, 2. local anesthetic infiltration (LAI), 3. combined TAP+LAI, 4. control (no regional anesthesia). Each participant remained in the assigned group throughout the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warmia and Mazury in Olsztyn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Dyśko, University of Warmia and Mazury in Olsztyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176299
- Sponsor's protocol ID
- University of Warmia and Mazur
- Acronym
- TAP vs LAI
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this was a single-center clinical study and data contain sensitive patient information that cannot be fully anonymized for public release.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Unilateral Laparoscopic Transversus Abdominis Plane Block Compared to Local Infiltration in Postoperative Analgesia Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07176299
- Acronym / sponsor ID
- TAP vs LAI / University of Warmia and Mazur
- Conditions
- Cholelithiasis, Cholecystectomy, Laparoscopic, Pain, Postoperative, Anesthesia, Local, Nerve Block
- Keywords
- Laparoscopic cholecystectomy, unilateral transversus abdominis plane block, local anesthetic infiltration, postoperative pain management, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Warmia and Mazury in OlsztynUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 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.
This study compared different methods of pain control after laparoscopic gallbladder removal. A total of 160 patients were randomly assigned to receive either a unilateral laparoscopic TAP block, local anesthetic infiltration, a combination of both, or no regional anesthesia. Pain scores, use of pain medication, and complications were measured up to 24 hours after surgery. The TAP block group experienced less pain and fewer wound-related problems, showing that this method is safe and effective for postoperative pain relief.
Detailed description
Gallbladder stones are a common condition, and laparoscopic cholecystectomy is the standard treatment. Effective pain control after surgery is important for recovery and patient comfort. Traditionally, local anesthetic infiltration (LAI) at the surgical wound sites is used. Another method, the transversus abdominis plane (TAP) block, may provide better pain relief.
This prospective, randomized clinical trial was conducted at the University Clinical Hospital in Olsztyn, Poland. A total of 160 patients undergoing elective laparoscopic cholecystectomy were randomized into four groups: TAP block, LAI, TAP+LAI, and control. All patients received the same type of anesthesia and standard pain medications.
The primary goal was to compare pain intensity within 24 hours after surgery using the Numerical Rating Scale (NRS). Secondary measures included use of additional painkillers, recovery scores (Aldrete), and possible complications at the wound site. The influence of surgical drains and gallstone size on pain was also examined.
The study found that the unilateral laparoscopic TAP block provided the best pain relief, fewer wound-related complications, and reduced need for additional medications compared with other methods. These results suggest that the laparoscopic TAP block is a safe and effective option for improving postoperative pain management after gallbladder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were randomly assigned in a 1:1:1:1 ratio to one of four parallel groups: 1. unilateral laparoscopic TAP block, 2. local anesthetic infiltration (LAI), 3. combined TAP+LAI, 4. control (no regional anesthesia). Each participant remained in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| TAP Block | Experimental | Procedure: Unilateral laparoscopic TAP block (0.25% bupivacaine)Participants received a unilateral laparoscopic transversus abdominis plane (TAP) block performed under direct laparoscopic vision using 20 mL of 0.25% bupivacaine. |
| Local Anesthetic Infiltration (LAI) | Active comparator | Procedure: Local anesthetic infiltration (0.25% bupivacaine)Participants received local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites under laparoscopic guidance. |
| TAP + LAI | Experimental | Procedure: Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)Participants received a combination of unilateral laparoscopic TAP block (10 mL of 0.25% bupivacaine) and local anesthetic infiltration at trocar sites (10 mL of 0.25% bupivacaine). |
| Control (No Regional Anesthesia) | No intervention | –Participants did not receive regional anesthesia. Postoperative pain management was provided only with standardized intravenous analgesics. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 20 to 85 years
- Scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis confirmed by ultrasonography
- American Society of Anesthesiologists (ASA) physical status I-II
- Provided written informed consent
Key exclusion criteria (9 listed)
- ASA physical status III-IV
- Contraindications to laparoscopy
- Acute cholecystitis diagnosed preoperatively or perioperatively
- Chronic analgesic use
- Spinal degenerative joint disease
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 |
|---|---|---|
| Unilateral laparoscopic TAP block (0.25% bupivacaine)Injection of 20 mL 0.25% bupivacaine into the transversus abdominis plane under direct laparoscopic vision. | Procedure or surgery | TAP Block |
| Local anesthetic infiltration (0.25% bupivacaine)Injection of 20 mL 0.25% bupivacaine distributed across trocar insertion sites under laparoscopic guidance. | Procedure or surgery | Local Anesthetic Infiltration (LAI) |
| Combined TAP block and local anesthetic infiltration (0.25% bupivacaine)10 mL of 0.25% bupivacaine given as a TAP block and 10 mL administered as local infiltration at trocar sites. | Procedure or surgery | TAP + LAI |
Primary outcome
Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy
Time frame: Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day.
Pain intensity was assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Scores were recorded by patients at rest at three time points after laparoscopic cholecystectomy: 2 hours, 6 hours, and 24 hours postoperatively. Pain was evaluated as an overall score and at specific surgical sites (umbilical, subcostal, and substernal wounds). Assessments were performed only when patients reached an adequate level of consciousness, verified by Aldrete score.
1 secondary outcome
Use of rescue analgesics (metamizole, paracetamol, oxycodone) within 24 hours after laparoscopic cholecystectomy
Time frame: Rescue analgesic use assessed at 6, 12, 18, and 24 hours after surgery during the first postoperative day.
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 22 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this was a single-center clinical study and data contain sensitive patient information that cannot be fully anonymized for public release.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral laparoscopic TAP block (0.25% bupivacaine), Local anesthetic infiltration (0.25% bupivacaine) and Combined TAP block and local anesthetic infiltration (0.25% bupivacaine) in people with Cholelithiasis and Cholecystectomy, Laparoscopic, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.
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 9 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 22 Sep 2025. 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 Poland. 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?
Pain intensity measured by Numerical Rating Scale (NRS) at 2, 6, and 24 hours after laparoscopic cholecystectomy (time frame: Pain scores were recorded at 2 hours, 6 hours, and 24 hours after laparoscopic cholecystectomy during the first postoperative day.). 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 22 Sep 2025.