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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autonomic Neural Blockade | Experimental | This group will receive the Autonomic nerve block performed with:
|
|
| NO BLOCKADE | No Intervention | Patients will undergo a laparoscopic cholecystectomy without an autonomic neural blockade |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic neural blockade | Procedure | Autonomic nerve block performed with:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative analgesic doses | acetaminophen 1g oral tablets | up to 72 hours |
| postoperative analgesic doses-rescue 1 | Ibuprofen 400 mg oral tablets | up to 72 hours |
| postoperative analgesic doses-rescue 2 | acetaminophen 300 mg plus codeine 8 mg oral tablets | up to 72 hours |
| postoperative analgesic-rescue 3 | Ketorolac (30 mg) + Hyoscine (20 mg) intramuscular ampules | up to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| pain level | Visual Analog Scale (VAS) scores will be recorded (0-10) | 1, 24 and 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea | presence of nausea | 1,8 and 24 hours after surgery |
| postoperative vomiting | presence of vomiting | 1,8,24 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
Associated biliary pathologies (e.g., biliary pancreatitis, cholangitis).
Allergies to local anesthetics
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Daes, MD | Contact | +573106363636 | jorgedaez@gmail.com | |
| Andres Hanssen, MD | Contact | +573123012321 | anhanssen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Portoazul | Recruiting | Barranquilla | Atlantivo | 080020 | Colombia | |
| clinica Iberoamerica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36050617 | Result | 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. | |
| 38091501 |
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the raw data of the study( all IPD that underlie results in a publication) will be shared with the reviewers of the correspondent Journal
during the review process in the indicated Journal
though the corresponding Journal"s editorial manager.
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| ID | Term |
|---|---|
| D059265 | Visceral Pain |
| D000377 | Agnosia |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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randomized, parallel assignment, Double-Blind (Participant, Investigator), Preventive
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Randomization will be conducted using sealed envelopes stratified by the institution in blocks of six. The data manager will prepare and store the randomization list, and only they will have access to it during the study. The sealed envelopes will be placed in the patient's medical record and opened only when the patient is in the operating room and general anesthesia has been initiated. Both the patient and the independent investigator evaluating the data will remain blinded to the treatment group assignments.
| Recruiting |
| Barranquilla |
| Atlántico |
| 080020 |
| Colombia |
|
| Daes 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. |
| 39382864 | Result | Daes 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. |
| 41530355 | Derived | Daes 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |