Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy
NCT ID: NCT06632184
Last Updated: 2025-12-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-01
Study Completion Date
2026-03-31
Brief Summary
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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.
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.
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.
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.
Detailed Description
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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.
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.
Conditions
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Postoperative Pain Management
Laparoscopic Cholecystectomy
Ondansetron
Postoperative Nausea and Vomiting
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
This is a triple-blind study. Beyond the participant, the following key parties are masked: the surgeons performing the procedure, the anesthesiologists managing perioperative care, and the post-operative outcome assessors (e.g., research interns collecting pain scores and other clinical data). A designated "blinding coordination nurse," who is not involved in any clinical or assessment roles, prepares the identical-looking solutions according to the randomization sequence. The data analyst will also remain masked to group allocation (coded as A/B) until the completion of the primary statistical analysis.
Study Groups
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Saline Lavage Only
Participants 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.
Group Type
ACTIVE_COMPARATOR
Saline Intraperitoneal Lavage
Intervention Type
DRUG
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.
Saline Lavage With Ondansetron
Participants 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.
Group Type
EXPERIMENTAL
Ondansetron Intraperitoneal Lavage
Intervention Type
DRUG
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.
Interventions
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Ondansetron Intraperitoneal Lavage
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.
Intervention Type
DRUG
Saline Intraperitoneal Lavage
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.
Intervention Type
DRUG
Other Intervention Names
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Ondansetron
Zofran
0.9% Sodium Chloride
normal saline
0.9% Sodium Chloride
Saline Solution
Eligibility Criteria
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Inclusion Criteria
Patients meeting all the following criteria will be considered for enrollment:
1. Aged between 18 and 60 years.
2. American Society of Anesthesiologist (ASA) physical status classification I or II.
3. Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp.
4. 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.
5. Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale
6. Ability to provide written, informed consent
1. Aged between 18 and 60 years.
2. American Society of Anesthesiologist (ASA) physical status classification I or II.
3. Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp.
4. 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.
5. Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale
6. Ability to provide written, informed consent
Exclusion Criteria
Patients presenting with any of the following will be excluded:
1. Confirmed pregnancy or lactation
2. 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)
8\. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2)
9\. History of recurrent vertigo or motion sickness
Elimination Criteria
1. Confirmed pregnancy or lactation
2. 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)
8\. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2)
9\. History of recurrent vertigo or motion sickness
Elimination Criteria
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Francisco Aguilar Espinosa
General Surgery department: Dr. Francisco Aguilar Espinosa, Clinical Research
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Francisco Aguilar Espinosa, Dr.
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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General Hospital No. 89 of the Mexican Social Security Institute (IMSS)
Guadalajara, Jalisco, Mexico
Site Status
Countries
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Mexico
References
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Labaille T, Mazoit JX, Paqueron X, Franco D, Benhamou D. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg. 2002 Jan;94(1):100-5, table of contents. doi: 10.1097/00000539-200201000-00019.
Reference Type
RESULT
Melidi E, Papadima A, Pandazi A, Zografos G. Efficacy of Repeated Intraperitoneal Administration of Levobupivacaine in Pain and Opioid Consumption After Elective Laparoscopic Cholecystectomy: A Prospective Randomized Placebo-controlled Trial. Surg Laparosc Endosc Percutan Tech. 2016 Aug;26(4):295-300. doi: 10.1097/SLE.0000000000000297.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Rahimzadeh P, Faiz SHR, Hoseini M, Mousavie SH, Imani F, Negah AR. Comparison of intraperitoneal bupivacaine, acetazolamide, and placebo on pain relief after laparoscopic cholecystectomy surgery: A clinical trial. Med J Islam Repub Iran. 2018 Nov 13;32:112. doi: 10.14196/mjiri.32.112. eCollection 2018.
Reference Type
RESULT
Putta PG, Pasupuleti H, Samantaray A, Natham H, Rao MH. A comparative evaluation of pre-emptive versus post-surgery intraperitoneal local anaesthetic instillation for postoperative pain relief after laparoscopic cholecystectomy: A prospective, randomised, double blind and placebo controlled study. Indian J Anaesth. 2019 Mar;63(3):205-211. doi: 10.4103/ija.IJA_767_18.
Reference Type
RESULT
Nikoubakht N, Faiz SHR, Mousavie SH, Shafeinia A, Borhani Zonoz L. Effect of bupivacaine intraperitoneal and intra-abdominal bicarbonate in reducing postoperative pain in laparoscopic cholecystectomy: a double-blind randomized clinical trial study. BMC Res Notes. 2022 Jun 3;15(1):191. doi: 10.1186/s13104-022-06083-3.
Reference Type
RESULT
Honca M, Kose EA, Bulus H, Horasanli E. The postoperative analgesic efficacy of intraperitoneal bupivacaine compared with levobupivacaine in laparoscopic cholecystectomy. Acta Chir Belg. 2014 May-Jun;114(3):174-8. doi: 10.1080/00015458.2014.11681004.
Reference Type
RESULT
Abdelhedi A, Ketata S, Kardoun N, Keskes M, Zouche I, Ayedi A, Doukeli O, Khrouf M, Fendri S, Zouari A, Cheikhrouhou H. [The effect of intraperitoneal administration of dexamethasone on postoperative analgesia after laparoscopic cholecystectomy: a prospective randomized controlled double-blind study]. Pan Afr Med J. 2023 May 4;45:14. doi: 10.11604/pamj.2023.45.14.36438. eCollection 2023. French.
Reference Type
RESULT
Kaushal-Deep SM, Anees A, Khan S, Khan MA, Lodhi M. Randomized controlled study of intraincisional infiltration versus intraperitoneal instillation of standardized dose of ropivacaine 0.2% in post-laparoscopic cholecystectomy pain: Do we really need high doses of local anesthetics-time to rethink! Surg Endosc. 2018 Jul;32(7):3321-3341. doi: 10.1007/s00464-018-6053-z. Epub 2018 Jan 16.
Reference Type
RESULT
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
Reference Type
RESULT
Al Shoyaib A, Archie SR, Karamyan VT. Intraperitoneal Route of Drug Administration: Should it Be Used in Experimental Animal Studies? Pharm Res. 2019 Dec 23;37(1):12. doi: 10.1007/s11095-019-2745-x.
Reference Type
RESULT
Roila F, Del Favero A. Ondansetron clinical pharmacokinetics. Clin Pharmacokinet. 1995 Aug;29(2):95-109. doi: 10.2165/00003088-199529020-00004.
Reference Type
RESULT
Skovgard K, Agerskov C, Kohlmeier KA, Herrik KF. The 5-HT3 receptor antagonist ondansetron potentiates the effects of the acetylcholinesterase inhibitor donepezil on neuronal network oscillations in the rat dorsal hippocampus. Neuropharmacology. 2018 Dec;143:130-142. doi: 10.1016/j.neuropharm.2018.09.017. Epub 2018 Sep 19.
Reference Type
RESULT
McCleane GJ, Suzuki R, Dickenson AH. Does a single intravenous injection of the 5HT3 receptor antagonist ondansetron have an analgesic effect in neuropathic pain? A double-blinded, placebo-controlled cross-over study. Anesth Analg. 2003 Nov;97(5):1474-1478. doi: 10.1213/01.ANE.0000085640.69855.51.
Reference Type
RESULT
Li CJ, Zhang LG, Liu LB, An MQ, Dong LG, Gu HY, Dai YP, Wang F, Mao CJ, Liu CF. Inhibition of Spinal 5-HT3 Receptor and Spinal Dorsal Horn Neuronal Excitability Alleviates Hyperalgesia in a Rat Model of Parkinson's Disease. Mol Neurobiol. 2022 Dec;59(12):7253-7264. doi: 10.1007/s12035-022-03034-8. Epub 2022 Sep 27.
Reference Type
RESULT
Khasabov SG, Lopez-Garcia JA, Asghar AU, King AE. Modulation of afferent-evoked neurotransmission by 5-HT3 receptors in young rat dorsal horn neurones in vitro: a putative mechanism of 5-HT3 induced anti-nociception. Br J Pharmacol. 1999 Jun;127(4):843-52. doi: 10.1038/sj.bjp.0702592.
Reference Type
RESULT
Ye JH, Mui WC, Ren J, Hunt TE, Wu WH, Zbuzek VK. Ondansetron exhibits the properties of a local anesthetic. Anesth Analg. 1997 Nov;85(5):1116-21. doi: 10.1097/00000539-199711000-00029.
Reference Type
RESULT
Khoori M, Mirghaderi P, Azarboo A, Jamil F, Eshraghi N, Baghaei AA. Effect of Ondansetron on Postoperative Pain and Vomiting after Acute Appendicitis Surgery: A Placebo-Controlled Double-Blinded Randomized Clinical Trial. Pain Res Manag. 2024 Jun 12;2024:6429874. doi: 10.1155/2024/6429874. eCollection 2024.
Reference Type
RESULT
Ye JH, Ponnudurai R, Schaefer R. Ondansetron: a selective 5-HT(3) receptor antagonist and its applications in CNS-related disorders. CNS Drug Rev. 2001 Summer;7(2):199-213. doi: 10.1111/j.1527-3458.2001.tb00195.x.
Reference Type
RESULT
Giordano J, Dyche J. Differential analgesic actions of serotonin 5-HT3 receptor antagonists in the mouse. Neuropharmacology. 1989 Apr;28(4):423-7. doi: 10.1016/0028-3908(89)90040-3.
Reference Type
RESULT
Zeitz KP, Guy N, Malmberg AB, Dirajlal S, Martin WJ, Sun L, Bonhaus DW, Stucky CL, Julius D, Basbaum AI. The 5-HT3 subtype of serotonin receptor contributes to nociceptive processing via a novel subset of myelinated and unmyelinated nociceptors. J Neurosci. 2002 Feb 1;22(3):1010-9. doi: 10.1523/JNEUROSCI.22-03-01010.2002.
Reference Type
RESULT
Sufka KJ, Schomburg FM, Giordano J. Receptor mediation of 5-HT-induced inflammation and nociception in rats. Pharmacol Biochem Behav. 1992 Jan;41(1):53-6. doi: 10.1016/0091-3057(92)90058-n.
Reference Type
RESULT
Farouk S. Ondansetron added to lidocaine for intravenous regional anaesthesia. Eur J Anaesthesiol. 2009 Dec;26(12):1032-6. doi: 10.1097/EJA.0b013e3283317d93.
Reference Type
RESULT
Wolf H. Preclinical and clinical pharmacology of the 5-HT3 receptor antagonists. Scand J Rheumatol Suppl. 2000;113:37-45. doi: 10.1080/030097400446625.
Reference Type
RESULT
Rusch D, Eberhart LH, Wallenborn J, Kranke P. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010 Oct;107(42):733-41. doi: 10.3238/arztebl.2010.0733. Epub 2010 Oct 22.
Reference Type
RESULT
Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth Analg. 2006 Jun;102(6):1884-98. doi: 10.1213/01.ANE.0000219597.16143.4D.
Reference Type
RESULT
Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.
Reference Type
RESULT
Mouton WG, Bessell JR, Otten KT, Maddern GJ. Pain after laparoscopy. Surg Endosc. 1999 May;13(5):445-8. doi: 10.1007/s004649901011.
Reference Type
RESULT
Bisgaard T, Kehlet H, Rosenberg J. Pain and convalescence after laparoscopic cholecystectomy. Eur J Surg. 2001 Feb;167(2):84-96. doi: 10.1080/110241501750070510.
Reference Type
RESULT
Barazanchi AWH, MacFater WS, Rahiri JL, Tutone S, Hill AG, Joshi GP; PROSPECT collaboration. Evidence-based management of pain after laparoscopic cholecystectomy: a PROSPECT review update. Br J Anaesth. 2018 Oct;121(4):787-803. doi: 10.1016/j.bja.2018.06.023. Epub 2018 Aug 7.
Reference Type
RESULT
Abdelaziz DH, Boraii S, Cheema E, Elnaem MH, Omar T, Abdelraouf A, Mansour NO. The intraperitoneal ondansetron for postoperative pain management following laparoscopic cholecystectomy: A proof-of-concept, double-blind, placebo-controlled trial. Biomed Pharmacother. 2021 Aug;140:111725. doi: 10.1016/j.biopha.2021.111725. Epub 2021 May 18.
Reference Type
RESULT
Ko-Iam W, Paiboonworachat S, Pongchairerks P, Junrungsee S, Sandhu T. Combination of etoricoxib and low-pressure pneumoperitoneum versus standard treatment for the management of pain after laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2016 Nov;30(11):4800-4808. doi: 10.1007/s00464-016-4810-4. Epub 2016 Feb 23.
Reference Type
RESULT
Kim HC, Song Y, Lee JS, Jeong ME, Lee Y, Lim JH, Kim DH. Comparison of pharmacologic therapies alone versus operative techniques in combination with pharmacologic therapies for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Int J Surg. 2022 Aug;104:106763. doi: 10.1016/j.ijsu.2022.106763. Epub 2022 Jul 6.
Reference Type
RESULT
Seo YK, Lee HJ, Ha TK, Lee KG. Effect of normal saline irrigation on attenuation of shoulder tip pain and on beta-endorphin levels after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2012 May;22(4):311-4. doi: 10.1089/lap.2011.0365. Epub 2012 Jan 30.
Reference Type
RESULT
Bala I, Bhatia N, Mishra P, Verma GR, Kaman L. Comparison of preoperative oral acetazolamide and intraperitoneal normal saline irrigation for reduction of postoperative pain after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2015 Apr;25(4):285-90. doi: 10.1089/lap.2014.0507. Epub 2015 Mar 13.
Reference Type
RESULT
Barthelsson C, Sandblom G, Ljesevic-Nikoletic S, Hammarqvist F. Effects of Intra-abdominally Instilled Isotonic Saline on Pain, Recovery, and Health-Related Quality-of-Life Following Laparoscopic Cholecystectomy: A Randomized Prospective Double-Blind Controlled Study. World J Surg. 2015 Jun;39(6):1413-20. doi: 10.1007/s00268-015-2978-8.
Reference Type
RESULT
Allen RW, Burney CP, Davis A, Henkin J, Kelly J, Judd BG, Ivatury SJ. Deep Sleep and Beeps: Sleep Quality Improvement Project in General Surgery Patients. J Am Coll Surg. 2021 Jun;232(6):882-888. doi: 10.1016/j.jamcollsurg.2021.02.010. Epub 2021 Mar 3.
Reference Type
RESULT
Abdelraheem Mohamed M, Elsayed HM, Badawy FA. A comparative study of the analgesic efficacy of intraperitoneal instillation of diluted bupivacaine versus non-diluted bupivacaine after laparoscopic cholecystectomy: a prospective single-blinded controlled randomized study. Egypt J Anaesth. 2023;39(1):1-6.
Reference Type
RESULT
Awolaran O, Gana T, Samuel N, Oaikhinan K. Readmissions after laparoscopic cholecystectomy in a UK District General Hospital. Surg Endosc. 2017 Sep;31(9):3534-3538. doi: 10.1007/s00464-016-5380-1. Epub 2016 Dec 23.
Reference Type
RESULT
Moghadamyeghaneh Z, Badami A, Masi A, Misawa R, Dresner L. Unplanned readmission after outpatient laparoscopic cholecystectomy. HPB (Oxford). 2020 May;22(5):702-709. doi: 10.1016/j.hpb.2019.09.005. Epub 2019 Sep 28.
Reference Type
RESULT
Rosero EB, Joshi GP. Hospital readmission after ambulatory laparoscopic cholecystectomy: incidence and predictors. J Surg Res. 2017 Nov;219:108-115. doi: 10.1016/j.jss.2017.05.071. Epub 2017 Jun 28.
Reference Type
RESULT
Keus F, de Jong JA, Gooszen HG, van Laarhoven CJ. Laparoscopic versus small-incision cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev. 2006 Oct 18;2006(4):CD006229. doi: 10.1002/14651858.CD006229.
Reference Type
RESULT
Mendez Sanchez N, Uribe Esquivel M, Jessurun Solomou J, Cervera Ceballos E, Bosques Padilla F. [Epidemiology of gallstone disease in Mexico]. Rev Invest Clin. 1990 Jul;42 Suppl:48-52. Spanish.
Reference Type
RESULT
Cobos-Carbo A; CONSORT group. [Randomized clinical trials (CONSORT)]. Med Clin (Barc). 2005 Dec 1;125 Suppl 1:21-7. doi: 10.1016/s0025-7753(05)72205-3. Spanish.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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R-2025-785-080
Identifier Type: OTHER
Identifier Source: secondary_id
F-CNIC-2024-097
Identifier Type: -
Identifier Source: org_study_id