CholecystitisNCT07871617
Prophylactic TAP Block in Laparoscopic Cholecystectomy
A study testing Analgesic and Analgesic transversus abdominal plane blockade (Bupivacaine) in people with Cholecystitis, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
Trial summary
Laparoscopic cholecystectomy is the gold standard for cholelithiasis, yet postoperative pain remains a clinical challenge. Ultrasound-guided transversus abdominis plane (TAP) block has been proposed as an effective analgesic strategy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Analgesic and Analgesic transversus abdominal plane blockade (Bupivacaine)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2025to 14 Nov 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders
- 18 years and older
- ASA I-II
- Programmed for a laparoscopic cholecystectomy
- Who agree to participate
Who cannot join
- Younger than 18 years old
- ASA III-IV
- Known allergy to local anesthetics
- Infection at the site for blockade
- Inability to communicate pain
- Known history of coagulopathy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
"Dr. Salvador Zubirán Anchondo" General Hospital
Chihuahua City, Chihuahua, 31100
About this study
Official title: Prophylactic Transversus Abdominis Plane Block for Enhanced Postoperative Analgesia in Elective Laparoscopic Cholecystectomy.
Laparoscopic cholecystectomy is the gold standard for cholelithiasis, yet postoperative pain remains a clinical challenge. Ultrasound-guided transversus abdominis plane (TAP) block has been proposed as an effective analgesic strategy. The objective of this study is to evaluate the effectiveness of prophylactic bilateral TAP block in patients undergoing elective laparoscopic cholecystectomy.
Read the detailed description
A prospective, randomized clinical trial was conducted at the "Dr. Salvador Zubirán Anchondo" General Hospital in Chihuahua, where adult patients scheduled for elective laparoscopic cholecystectomy were included. The intervention group received an ultrasound-guided bilateral TAP block prior to incision, while the control group received conventional analgesic management. Pain intensity was assessed using the Numerical Rating Scale (NRS) at 2, 6, 12, and 24 hours postoperatively; opioid consumption and adverse events were also recorded.
- Conditions
- Cholecystitis
- Being tested
- Analgesic, Analgesic transversus abdominal plane blockade (Bupivacaine)
- Keywords
- Anesthesia, local, cholecystectomy, laparoscopic, Analgesia, Postoperative pain
- Medical subject headings
- Cholecystitis, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalgesicDrug
Administration of any analgesic medication (e.g. paracetamol, diclofenac, etc.)
Analgesic transversus abdominal plane blockade (Bupivacaine)Procedure or surgery
Ultrasound-guided bilateral TAP blockade before incision.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Usual pain management Receives: Drug: Analgesic |
| Experimental group | Experimental | Ultrasound-guided bilateral TAP block prior to incision Receives: Procedure: Analgesic transversus abdominal plane blockade (Bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative abdominal pain
Discomfort or nociceptive signaling originating in the abdominal wall that occurs as a direct consequence of the surgical procedure. Pain intensity was assessed using the Numerical Rating Scale (NRS) at predefined postoperative intervals (2, 6, 12, and 24 hours).
Measured: From the end of the surgical procedure and for up to 24 hours
Secondary outcomes (2)
Opioid consumption
The cumulative amount of opioid medication the patient takes during a specific recovery timeframe following the surgical procedure
Measured: From the end of the surgical procedure and for up to 24 hours
Nausea/Vomiting
A common side effect of surgery and anesthesia defined as any nausea, retching, or vomiting that happens within the first 24 to 48 hours after a procedure
Measured: From the end of the surgical procedure and for up to 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 Oct 2026
- Study start1 Aug 2025
- Primary completion31 Oct 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carlos R. Cervantes Sanchez, MD, MSc, Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Investigators
- Rubén Cuevas-Martínez, MD, MSc, Study chair, "Dr. Salvador Zubirán Anchondo" General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871617
- Sponsor's protocol ID
- 2025/0419
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2026
- Last updated
- 13 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Transversus Abdominis Plane Block for Enhanced Postoperative Analgesia in Elective Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT07871617
- Acronym / sponsor ID
- 2025/0419
- Conditions
- Cholecystitis
- Keywords
- Anesthesia, local, cholecystectomy, laparoscopic, Analgesia, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán AnchondoOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 13 Oct 2026 (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.
Laparoscopic cholecystectomy is the gold standard for cholelithiasis, yet postoperative pain remains a clinical challenge. Ultrasound-guided transversus abdominis plane (TAP) block has been proposed as an effective analgesic strategy. The objective of this study is to evaluate the effectiveness of prophylactic bilateral TAP block in patients undergoing elective laparoscopic cholecystectomy.
Detailed description
A prospective, randomized clinical trial was conducted at the "Dr. Salvador Zubirán Anchondo" General Hospital in Chihuahua, where adult patients scheduled for elective laparoscopic cholecystectomy were included. The intervention group received an ultrasound-guided bilateral TAP block prior to incision, while the control group received conventional analgesic management. Pain intensity was assessed using the Numerical Rating Scale (NRS) at 2, 6, 12, and 24 hours postoperatively; opioid consumption and adverse events were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: AnalgesicUsual pain management |
| Experimental group | Experimental | Procedure: Analgesic transversus abdominal plane blockade (Bupivacaine)Ultrasound-guided bilateral TAP block prior to incision |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both genders
- 18 years and older
- ASA I-II
- Programmed for a laparoscopic cholecystectomy
- Who agree to participate
Key exclusion criteria (6 listed)
- Younger than 18 years old
- ASA III-IV
- Known allergy to local anesthetics
- Infection at the site for blockade
- Inability to communicate pain
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 |
|---|---|---|
| AnalgesicAdministration of any analgesic medication (e.g. paracetamol, diclofenac, etc.) | Drug | Control group |
| Analgesic transversus abdominal plane blockade (Bupivacaine)Ultrasound-guided bilateral TAP blockade before incision. | Procedure or surgery | Experimental group |
Primary outcome
Post-operative abdominal pain
Time frame: From the end of the surgical procedure and for up to 24 hours
Discomfort or nociceptive signaling originating in the abdominal wall that occurs as a direct consequence of the surgical procedure. Pain intensity was assessed using the Numerical Rating Scale (NRS) at predefined postoperative intervals (2, 6, 12, and 24 hours).
2 secondary outcomes
Opioid consumption
Time frame: From the end of the surgical procedure and for up to 24 hours
Nausea/Vomiting
Time frame: From the end of the surgical procedure and for up to 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 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.
Rubén Cuevas-Martínez, MD, MSc study chair
"Dr. Salvador Zubirán Anchondo" General 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 Analgesic and Analgesic transversus abdominal plane blockade (Bupivacaine) in people with Cholecystitis, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
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 6 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 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 Mexico. 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?
Post-operative abdominal pain (time frame: From the end of the surgical procedure and for up to 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 Oct 2026.