Visceral PainPhase 4ANBNCT06753500
Intraoperative Autonomic Blockade for Laparoscopic Cholecystectomy
A Phase 4 study testing Autonomic neural blockade in people with Visceral Pain and Analgesia, run by Universidad Simón Bolívar at 2 sites in Colombia.
Trial summary
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral Pain, Analgesia, Opioid Use
- What is being tested?
- Autonomic neural blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesColombia
- Study dates
- 15 Jan 2025to 4 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis.
Who cannot join
- Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis).
- Additional procedures, such as formal bile duct exploration. Conversion to an open approach
- Anesthesia or Surgical complications that require intensive care unit
- Allergies to local anesthetics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites, 2 recruiting
- Recruiting
Clinica Portoazul
Barranquilla, Atlantivo, 080020
- Recruiting
clinica Iberoamerica
Barranquilla, Atlántico, 080020
Roberto Tarud, +57 3184187524, rtarud@colsanitas.com
About this study
Official title: Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to improve visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
Read the detailed description
Introduction
Laparoscopic cholecystectomy is the second most commonly performed procedure by general surgeons. While laparoscopy results in shorter recovery times and less intense pain compared to open surgery, it does not entirely eliminate postoperative pain, which remains the primary reason for hospitalization or readmission. Consequently, most patients undergoing laparoscopic cholecystectomy require hospitalization for 24 to 48 hours.
Postoperative pain frequently occurs after cholecystectomy, stemming from surgical incisions, manipulation of surrounding tissues, and postoperative inflammation. Various methods for pain control have been investigated, including analgesics, anti-inflammatory medication, peripheral nerve blocks, and physical interventions.
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to enhance visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
Justification
To date, no studies have shown the effect of visceral blockade on postoperative pain control in laparoscopic cholecystectomy. With the advancement of minimally invasive surgery, outpatient management of patients has become a realistic goal, presenting a challenge for surgeons to achieve adequate pain control and quicker recovery. Blocking the hepatoduodenal ligament provides an alternative for managing visceral pain by targeting the hepatic branches of the celiac plexus.
Objectives
General Objective To evaluate the effect of intraoperative infiltration of Bupivacaine and Dexamethasone into the hepatoduodenal ligament and the visceral peritoneum reflection of the gallbladder cystic plate (autonomic blockade) on postoperative pain and analgesic requirements in patients undergoing laparoscopic cholecystectomy.
Specific Objectives
- To evaluate whether autonomic blockade reduces the consumption of postoperative opioid analgesics.
- To assess whether autonomic blockade shortens hospital stay duration.
- To determine whether autonomic blockade decreases the incidence of nausea and vomiting during the immediate postoperative period.
- To evaluate the impact of autonomic blockade on hospitalization requirements (versus outpatient surgery) and the rate of readmissions.
- Being tested
- Autonomic neural blockade
- Keywords
- autonomic neural blockade,, Visceral pain, postoperative nausea, Postoperative vomiting, analgesic consumption, opioid use
- Medical subject headings
- Visceral Pain, Agnosia, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic neural blockadeProcedure or surgery
Also called BLOCKADE
Autonomic nerve block performed with:
- Bupivacaine: 20 mL of 0.5%.
- Dexamethasone: 8 mg.
| Study group | Role | What they receive |
|---|---|---|
| Autonomic Neural Blockade | Experimental | This group will receive the Autonomic nerve block performed with:
* Bupivacaine: 20 mL of 0.5%.
* Dexamethasone: 8 mg. Procedure: Percutaneous injection under direct laparoscopic visualization into the hepatoduodenal ligament and the visceral peritoneal reflection. Receives: Procedure: Autonomic neural blockade |
| NO BLOCKADE | No intervention | Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic doses
acetaminophen 1g oral tablets
Measured: up to 72 hours
postoperative analgesic doses-rescue 1
Ibuprofen 400 mg oral tablets
Measured: up to 72 hours
postoperative analgesic doses-rescue 2
acetaminophen 300 mg plus codeine 8 mg oral tablets
Measured: up to 72 hours
postoperative analgesic-rescue 3
Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules
Measured: up to 72 hours
Secondary outcomes (1)
pain level
Visual Analog Scale (VAS) scores will be recorded (0-10)
Measured: 1, 24 and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Jan 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion4 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Visceral 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, parallel assignment, Double-Blind (Participant, Investigator), Preventive
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Simón Bolívar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753500
- Sponsor's protocol ID
- PRO-CEI-USB-CE-0394-03
- Acronym
- ANB
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the raw data of the study( all IPD that underlie results in a publication) will be shared with the reviewers of the correspondent Journal
Publications
Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
PubMed 36050617Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
PubMed 38091501Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334.
PubMed 39382864Daes J, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Apr;40(4):2894-2901. doi: 10.1007/s00464-025-12542-2. Epub 2026 Jan 13.
PubMed 41530355
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Autonomic Blockade to Prevent Early Postoperative Pain After Laparoscopic Cholecystectomy: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06753500
- Acronym / sponsor ID
- ANB / PRO-CEI-USB-CE-0394-03
- Keywords
- autonomic neural blockade,, Visceral pain, postoperative nausea, Postoperative vomiting, analgesic consumption, opioid use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Simón BolívarUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 4 Nov 2025 (estimated)
- First posted
- 31 Dec 2024 (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 proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to improve visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
Detailed description
Introduction
Laparoscopic cholecystectomy is the second most commonly performed procedure by general surgeons. While laparoscopy results in shorter recovery times and less intense pain compared to open surgery, it does not entirely eliminate postoperative pain, which remains the primary reason for hospitalization or readmission. Consequently, most patients undergoing laparoscopic cholecystectomy require hospitalization for 24 to 48 hours.
Postoperative pain frequently occurs after cholecystectomy, stemming from surgical incisions, manipulation of surrounding tissues, and postoperative inflammation. Various methods for pain control have been investigated, including analgesics, anti-inflammatory medication, peripheral nerve blocks, and physical interventions.
This study proposes infiltrating the hepatoduodenal ligament and the serosal reflection of the gallbladder cystic plate with a combination of Bupivacaine (a long-acting local anesthetic) and Dexamethasone (a corticosteroid). This technique aims to block the hepatic branches of the celiac plexus to enhance visceral pain control and its associated clinical manifestations, reduce analgesic requirements, and lower readmission rates, thereby facilitating recovery.
Justification
To date, no studies have shown the effect of visceral blockade on postoperative pain control in laparoscopic cholecystectomy. With the advancement of minimally invasive surgery, outpatient management of patients has become a realistic goal, presenting a challenge for surgeons to achieve adequate pain control and quicker recovery. Blocking the hepatoduodenal ligament provides an alternative for managing visceral pain by targeting the hepatic branches of the celiac plexus.
Objectives
General Objective To evaluate the effect of intraoperative infiltration of Bupivacaine and Dexamethasone into the hepatoduodenal ligament and the visceral peritoneum reflection of the gallbladder cystic plate (autonomic blockade) on postoperative pain and analgesic requirements in patients undergoing laparoscopic cholecystectomy.
Specific Objectives
- To evaluate whether autonomic blockade reduces the consumption of postoperative opioid analgesics.
- To assess whether autonomic blockade shortens hospital stay duration.
- To determine whether autonomic blockade decreases the incidence of nausea and vomiting during the immediate postoperative period.
- To evaluate the impact of autonomic blockade on hospitalization requirements (versus outpatient surgery) and the rate of readmissions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, parallel assignment, Double-Blind (Participant, Investigator), Preventive
| Arm | Type | Receives |
|---|---|---|
| Autonomic Neural Blockade | Experimental | Procedure: Autonomic neural blockadeThis group will receive the Autonomic nerve block performed with: * Bupivacaine: 20 mL of 0.5%. * Dexamethasone: 8 mg. Procedure: Percutaneous injection under direct laparoscopic visualization into the hepatoduodenal ligament and the visceral peritoneal reflection. |
| NO BLOCKADE | No intervention | –Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective or emergency laparoscopic cholecystectomy for cholelithiasis with or without cholecystitis.
Key exclusion criteria (4 listed)
- Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis).
- Allergies to local anesthetics
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 |
|---|---|---|
| Autonomic neural blockadeAlso: BLOCKADEAutonomic nerve block performed with: * Bupivacaine: 20 mL of 0.5%. * Dexamethasone: 8 mg. | Procedure or surgery | Autonomic Neural Blockade |
Primary outcome
postoperative analgesic doses
Time frame: up to 72 hours
acetaminophen 1g oral tablets
postoperative analgesic doses-rescue 1
Time frame: up to 72 hours
Ibuprofen 400 mg oral tablets
postoperative analgesic doses-rescue 2
Time frame: up to 72 hours
acetaminophen 300 mg plus codeine 8 mg oral tablets
postoperative analgesic-rescue 3
Time frame: up to 72 hours
Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules
1 secondary outcome
pain level
Time frame: 1, 24 and 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 36050617Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
- Results publication: PubMed 38091501Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13.
- Results publication: PubMed 39382864Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334.
- Derived from this study: PubMed 41530355Daes J, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Apr;40(4):2894-2901. doi: 10.1007/s00464-025-12542-2. Epub 2026 Jan 13.
- Individual participant dataSharing planned: Yes. the raw data of the study( all IPD that underlie results in a publication) will be shared with the reviewers of the correspondent Journal
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autonomic neural blockade in people with Visceral Pain and Analgesia, run by Universidad Simón Bolívar at 2 sites in Colombia.
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 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Daes, MD (+573106363636, jorgedaez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative analgesic doses (time frame: up to 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753500, which also lists 4 linked publications.
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 28 Jan 2025.