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Postoperative Pain ManagementPhase 4PLUSONCT06632184

Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy

A Phase 4 study testing Ondansetron Intraperitoneal Lavage and Saline Intraperitoneal Lavage in people with Postoperative Pain Management and Laparoscopic Cholecystectomy, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Ondansetron Intraperitoneal Lavage and Saline Intraperitoneal Lavage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMexico
Study dates
1 Dec 2025to 31 Mar 2026
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients meeting all the following criteria will be considered for enrollment:
  • Aged between 18 and 60 years.
  • American Society of Anesthesiologist (ASA) physical status classification I or II.
  • Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp.
  • Placement of a ¾-inch Penrose drain in the subhepatic cavity as part of the standardized surgical technique, to allow evacuation of residual CO2, residual lavage fluid, and close monitoring for possible postoperative bleeding or bile leakage.
  • Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale
  • Ability to provide written, informed consent

Who cannot join

  • Patients presenting with any of the following will be excluded:
  • Confirmed pregnancy or lactation
  • Intraoperative findings of Nassar Grade IV, suspected gallbladder cancer, scleroatrophic gallbladder, or cirrhosis
  • 5. Use of NSAIDs within 24 hours prior to surgery, or chronic use of NSAIDs, opioids, immunosuppressants, chemotherapy, or anticoagulants.
  • 6. Known allergies to ondansetron, acetaminophen, diclofenac sodium, buprenorphine or tramadol
  • 7. Significant cardiac disease (e.g., heart failure, arrhythmias, pacemaker dependency)
Show all 10Show fewer
  • 8. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2)
  • 9. History of recurrent vertigo or motion sickness
  • Elimination Criteria
  • Patients who meet inclusion criteria but experience the following intraoperative events will be eliminated from the final per-protocol analysis: significant bleeding or bile duct injury requiring re-intervention, conversion to open surgery, or a total operative time exceeding 80 minutes.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • General Hospital No. 89 of the Mexican Social Security Institute (IMSS)

    Guadalajara, Jalisco, 44190

Other trials in Mexico

About this study

Official title: Pilot Comparative Study on the Efficacy of Multimodal Management With Peritoneal Lavage Using Saline Solution Versus Saline Solution With Ondansetron in Laparoscopic Cholecystectomy

Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Preliminary evidence suggests that adding ondansetron to the standard intraperitoneal saline lavage could provide additional analgesic and antiemetic benefits by blocking peripheral 5-HT3 receptors at the trauma site.

Objective: This pilot study aims to evaluate if intraperitoneal lavage with saline + 8mg ondansetron reduces the total burden of postoperative pain over the first 24 hours (Area Under the Curve of the Visual Analog Scale, AUC-VAS/24h) compared to saline lavage alone, within a standardized multimodal protocol.

Read more

Methods: This is a phase IV, pilot, randomized, controlled, triple-blind clinical trial. 40 adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis (Nassar Grade I-II difficulty) will be randomly assigned (1:1) to:

Control Group: 500 ml of 0.9% saline intraperitoneal lavage.

Intervention Group: 500 ml of 0.9% saline + 8 mg ondansetron intraperitoneal lavage.

The lavage is performed for 5 minutes at the end of surgery, followed by complete aspiration. All patients receive a strict multimodal perioperative protocol, including pre-incisional port site infiltration with bupivacaine 0.75%, standardized anesthesia, and postoperative analgesics. The use of intravenous ondansetron is prohibited to avoid confounding.

Primary Outcome: Total postoperative pain burden (AUC-VAS/24h). Secondary Outcomes (Exploratory): PONV incidence; time to first rescue analgesia; rescue analgesic consumption (buprenorphine); postoperative sleep quality (Richards-Campbell Sleep Questionnaire); safety and adverse events.

Read the detailed description
  1. Study Rationale and Background Postoperative pain and PONV are prevalent after laparoscopic cholecystectomy, leading to patient discomfort, prolonged hospitalization, and increased resource use. The PROSPECT guidelines recommend a multimodal approach, including intraperitoneal saline lavage, to mitigate pain by diluting irritants and reducing acidosis. However, even with this approach, PONV rates remain high (30-50%). Ondansetron, a 5-HT3 antagonist, is a established antiemetic. Emerging evidence indicates a peripheral analgesic mechanism via blocking 5-HT3 receptors on nociceptive neurons, inhibiting neuropeptide release, and potential local anesthetic effects. Administering it intraperitoneally targets the site of surgical trauma. A previous study (Abdelaziz et al., 2021) using 4mg showed promise, but it had a small sample size and was not integrated into a strict, modern multimodal protocol. This pilot study addresses this gap by testing an 8mg dose within a rigorous, standardized PROSPECT-aligned protocol, using the AUC-VAS/24h to comprehensively capture the pain burden.
  2. Overall Study Design and Methodology This is a single-center, prospective, phase IV, randomized, controlled, triple-blind, parallel-group pilot study, designed and reported according to CONSORT guidelines for pilot trials. Blinding (Triple): Patients are unaware of their assignment. Care Providers \& Outcome Assessors: Surgeons, anesthesiologists, nurses, and research interns collecting data are all blinded. Data Analyst: The statistician performs the initial analysis on coded data (Group A/B) before unblinding. Randomization: A computer-generated sequence using permuted blocks (sizes 4 and 6), stratified by sex and ASA status (I vs. II), will allocate patients 1:1. Allocation is concealed using sequentially numbered, opaque, sealed envelopes. A designated "blinding coordination nurse" opens the envelope, prepares the identical-looking study solution, and labels it only with a code (A or B).
  3. Standardization of Procedures A strict, standardized perioperative protocol is mandated for all participants to minimize variability. Preoperative: Dexamethasone 8mg IV (antiemetic), antibiotic prophylaxis. Intraoperative: Anesthesia: Standardized induction (Midazolam 0.02-0.03 mg/kg, Fentanyl 2-4 mcg/kg, Propofol 1-2 mg/kg, Cisatracurium 0.15 mg/kg) and maintenance (Sevoflurano 1-1.5 MAC). Multimodal analgesia: Acetaminophen 1g IV and Diclofenac 75mg IV. Surgery: Pneumoperitoneum pressure strictly maintained at 10-12 mmHg. Four-port technique with identical placement. Pre-incisional infiltration of all port sites with Bupivacaine 0.75% (up to 20 ml total). Critical view of safety dissection. Active and complete aspiration of pneumoperitoneum at closure. Intervention: The assigned solution (500ml) is instilled into the peritoneal cavity for 5 minutes with the patient in a 20° Trendelenburg position, followed by complete aspiration. Postoperative: Scheduled analgesics: Acetaminophen 1g (every 8 hours) and Diclofenac 75mg IV (every 12 hours). Rescue Analgesia: Buprenorphine 75mcg SC is administered only upon patient request AND a pain score ≥50mm on the VAS or ≥6 on the Faces Pain Scale-Revised (FPS-R). Rescue Antiemesis: Metoclopramida 10mg IV is permitted for PONV. The use of intravenous ondansetron is prohibited during the entire perioperative period to avoid confounding the intervention's effects.
  4. Objectives and Endpoints as a Pilot Study As a pilot trial, its primary goal is to assess feasibility, refine procedures, and obtain preliminary estimates of effect and variability to power a future definitive trial. The primary outcome, AUC-VAS/24h, integrates pain intensity and duration, providing a robust measure of the "total pain burden." All secondary outcomes (PONV, rescue analgesia consumption, sleep quality) are explicitly exploratory and hypothesis-generating.
  5. Safety and Monitoring The safety of intraperitoneal saline lavage and ondansetron is well-established. The combination presents minimal anticipated risk. All adverse events and postoperative complications will be actively monitored and recorded for the first 24 hours and up to 30 days post-surgery. An interim analysis for safety and efficacy will be conducted after 50% recruitment (n=20). Any serious adverse events will be reported promptly to the Institutional Ethics Committee.
  6. Significance This is the first study to evaluate the combination of standard saline lavage with 8mg of intraperitoneal ondansetron within a rigorously standardized, PROSPECT-aligned, multimodal protocol. Using a triple-blind pilot design and a comprehensive primary endpoint, it will generate high-quality preliminary evidence on this simple, low-cost intervention's efficacy and safety in a Mexican population. The results will determine the feasibility and inform the design of a larger, definitive multicenter randomized controlled trial.
Being tested
Ondansetron Intraperitoneal Lavage, Saline Intraperitoneal Lavage
Keywords
Laparoscopic cholecystectomy, Ondansetron Formulations, Intraperitoneal Analgesia, Saline Solution, Pain Management, Postoperative Nausea and Vomiting
Medical subject headings
Postoperative Nausea and Vomiting, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ondansetron Intraperitoneal LavageDrug

    Also called Ondansetron, Zofran, 0.9% Sodium Chloride

    A single dose of 8 mg of ondansetron diluted in 500 mL of 0.9% saline solution will be administered as an intraperitoneal lavage at the end of elective laparoscopic cholecystectomy. The solution will remain in the abdominal cavity for 5 minutes and then be fully aspirated before surgical closure. This intervention aims to evaluate the local analgesic and antiemetic effects of ondansetron when used via the peritoneal route.

  • Saline Intraperitoneal LavageDrug

    Also called normal saline, 0.9% Sodium Chloride, Saline Solution

    At the end of elective laparoscopic cholecystectomy, a peritoneal lavage will be performed using 500 mL of 0.9% saline solution (normal saline). The solution will be maintained in the peritoneal cavity for 5 minutes and then fully aspirated before surgical closure. This intervention serves as the comparator to assess the added effect of ondansetron in the experimental group.

Study groups in NCT06632184
Study groupRoleWhat they receive
Saline Lavage OnlyActive comparatorParticipants in this arm will receive intraoperative peritoneal lavage with 500 mL of 0.9% saline solution for 5 minutes at the end of laparoscopic cholecystectomy. The solution will be fully aspirated before abdominal closure. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.
Receives: Drug: Saline Intraperitoneal Lavage
Saline Lavage With OndansetronExperimentalParticipants in this arm will undergo peritoneal lavage with 500 mL of 0.9% saline solution combined with 8 mg of ondansetron, administered intraperitoneally at the end of elective laparoscopic cholecystectomy. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.
Receives: Drug: Ondansetron Intraperitoneal Lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Pain Burden as Measured by the Area Under the Curve (AUC) of Visual Analog Scale (VAS) Scores Over the First 24 Postoperative Hours

    The primary outcome is the total burden of postoperative pain, quantified as the Area Under the Curve (AUC) of serial Visual Analog Scale (VAS) scores measured at 0, 2, 6, 12, and 24 hours after surgery. The AUC is calculated using the trapezoidal rule, which integrates both the intensity and duration of pain into a single composite measure (units: mm*hour). This provides a more comprehensive assessment of the patient's pain experience over the critical first postoperative day than isolated time-point measurements. A lower AUC indicates superior pain control.

    Measured: 0, 2, 6, 12, and 24 hours postoperatively

Secondary outcomes (4)

  1. Incidence of Postoperative Nausea and Vomiting (PONV)

    The presence and number of postoperative nausea and vomiting (PONV)

    Measured: 0, 2, 6, 12, and 24 hours postoperatively

  2. Use of Rescue Analgesia Within 24 Hours Postoperatively

    The proportion of patients requiring rescue analgesia (buprenorphine 75 mcg subcutaneously) will be recorded. The time to first dose and the total number of doses will also be analyzed.

    Measured: 0 to 24 hours postoperatively

  3. Postoperative Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire

    Sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire, which includes six visual analog items rated from 0 to 100. A higher score indicates better sleep. The total average score will be calculated for each participant.

    Measured: Night of surgery to morning after surgery

  4. Incidence of Adverse Events Possibly Related to Intraperitoneal Ondansetron

    Any unexpected clinical signs, symptoms, or laboratory abnormalities that could be associated with the intraperitoneal use of ondansetron will be recorded and evaluated by the study team.

    Measured: 0 to 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start1 Dec 2025
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
nterventional Study Model: Parallel assignment. Participants are randomized into one of two parallel groups in a 1:1 ratio to receive either the experimental intervention or the control intervention for the duration of the study. The model incorporates triple-blinding (participant, care provider, outcomes assessor) and a randomized, controlled design. Allocation is performed using a computer-generated sequence with permuted blocks, stratified by sex and ASA physical status classification to ensure balanced groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632184
Sponsor's protocol ID
F-CNIC-2024-097
Other IDs
R-2025-785-080
Acronym
PLUSO
Status last verified
Dec 2025
First submitted
5 Oct 2024
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The decision to share individual participant data (IPD) has not yet been finalized. Data sharing will depend on the outcomes of the pilot study, ethical considerations, and institutional policies. Any future data sharing will ensure patient confidentiality and comply with regulatory standards.

Publications

  • Subhas G, Gupta A, Bhullar J, Dubay L, Ferguson L, Goriel Y, Jacobs MJ, Kolachalam RB, Silapaswan S, Mittal VK. Prolonged (longer than 3 hours) laparoscopic cholecystectomy: reasons and results. Am Surg. 2011 Aug;77(8):981-4.

    PubMed 21944510

  • Wang DE, Bakshi C, Sugiyama G, Coppa G, Alfonso A, Chung P. Does Operative Time Affect Complication Rate in Laparoscopic Cholecystectomy. Am Surg. 2023 Nov;89(11):4479-4484. doi: 10.1177/00031348221117032. Epub 2022 Aug 11.

    PubMed 38050322

  • Rudasill SE, Dillon D, Karunungan K, Mardock AL, Hadaya J, Sanaiha Y, Tran Z, Benharash P. The obesity paradox: Underweight patients are at the greatest risk of mortality after cholecystectomy. Surgery. 2021 Sep;170(3):675-681. doi: 10.1016/j.surg.2021.03.034. Epub 2021 Apr 28.

    PubMed 33933284

  • Reeves JJ, Burton BN, Broderick RC, Waterman RS, Gabriel RA. Obesity and unanticipated hospital admission following outpatient laparoscopic cholecystectomy. Surg Endosc. 2021 Mar;35(3):1348-1354. doi: 10.1007/s00464-020-07514-7. Epub 2020 Mar 23.

    PubMed 32206919

  • Augustin T, Moslim MA, Brethauer S, Aminian A, Kroh M, Schneider E, Walsh RM. Obesity and its implications for morbidity and mortality after cholecystectomy: A matched NSQIP analysis. Am J Surg. 2017 Mar;213(3):539-543. doi: 10.1016/j.amjsurg.2016.11.037. Epub 2017 Jan 26.

    PubMed 28237044

  • Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

    PubMed 20053272

  • Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

    PubMed 15189396

  • Miranda-Ackerman RC, Lira-Trujillo M, Gollaz-Cervantez AC, Cortes-Flores AO, Zuloaga-Fernandez Del Valle CJ, Garcia-Gonzalez LA, Morgan-Villela G, Barbosa-Camacho FJ, Pintor-Belmontes KJ, Guzman-Ramirez BG, Bernal-Hernandez A, Fuentes-Orozco C, Gonzalez-Ojeda A. Associations between stressors and difficulty sleeping in critically ill patients admitted to the intensive care unit: a cohort study. BMC Health Serv Res. 2020 Jul 9;20(1):631. doi: 10.1186/s12913-020-05497-8.

    PubMed 32646516

  • Garcia-Galicia A, Guzman-Maya I, Montiel-Jarquin AJ, Parra-Salazar JA, Gonzalez-Lopez AM, Loria-Castellanos J. Validation of a faces pain scale in postsurgical geriatric patients. Cir Cir. 2021;89(2):212-217. doi: 10.24875/CIRU.20000094.

    PubMed 33784276

  • Sandoval-Jimenez CH, Mendez-Sashida GJ, Cruz-Marquez-Rico LM, Cardenas-Victorica R, Guzman-Esquivel H, Luna-Silva M, Diaz-Valero R. [Postoperative pain in patients undergoing elective laparoscopic cholecystectomy with low versus standard-pressure pneumoperitoneum. A randomized clinical trial.]. Rev Gastroenterol Mex. 2009 Oct-Dec;74(4):314-20. Spanish.

    PubMed 20423760

  • Reddi BA. Why is saline so acidic (and does it really matter?). Int J Med Sci. 2013 Apr 17;10(6):747-50. doi: 10.7150/ijms.5868. Print 2013.

    PubMed 23630439

  • Graham CL, Dukes GE, Kao CF, Bertch JM, Hak LJ. Stability of ondansetron in large-volume parenteral solutions. Ann Pharmacother. 1992 Jun;26(6):768-71. doi: 10.1177/106002809202600603.

    PubMed 1535245

  • Zhang D, Wang X, Yang X, Xia D. The effect of intraperitoneal instillation of drugs on postoperative analgesia after laparoscopic cholecystectomy: a network meta-analysis. Front Pharmacol. 2025 Sep 12;16:1646917. doi: 10.3389/fphar.2025.1646917. eCollection 2025.

    PubMed 41020002

  • Sravanthi GC, Abuji K, Soni SL, Nagaraj SS, Sharma A, Jafra A, Tandup C, Kurdia KC, Dahiya D. Effect of intraperitoneal magnesium sulfate in the prevention of postoperative pain in daycare laparoscopic cholecystectomy - A prospective randomized controlled trial. Indian J Pharmacol. 2023 May-Jun;55(3):174-178. doi: 10.4103/ijp.ijp_827_22.

    PubMed 37555412

  • Vijayaraghavalu S, Bharthi Sekar E. A Comparative Study on the Postoperative Analgesic Effects of the Intraperitoneal Instillation of Bupivacaine Versus Normal Saline Following Laparoscopic Cholecystectomy. Cureus. 2021 Mar 27;13(3):e14151. doi: 10.7759/cureus.14151.

    PubMed 33927953

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ondansetron Intraperitoneal Lavage and Saline Intraperitoneal Lavage in people with Postoperative Pain Management and Laparoscopic Cholecystectomy, run by Instituto Mexicano del Seguro Social 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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 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.

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?

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?

Total Pain Burden as Measured by the Area Under the Curve (AUC) of Visual Analog Scale (VAS) Scores Over the First 24 Postoperative Hours (time frame: 0, 2, 6, 12, and 24 hours postoperatively). 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 NCT06632184, which also lists 58 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 16 Dec 2025.

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