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Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03583892
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ana Rita Marques Saraiva, Centro Hospitalar do Porto

Brief Summary:
The multimodal analgesia involves the administration of two or more analgesic agents that exert their effects via different analgesic mechanisms, providing superior analgesia with fewer side effects. This multimodal analgesic regimen includes opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and peripheral nerve blocks. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol.

Condition or disease Intervention/treatment
Pain, Postoperative Drug: Gabapentin

Detailed Description:

Postoperative pain after laparoscopic cholecystectomy is not only nociceptive but also inflammatory, neurogenic and visceral. Therefore, because of involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. The multimodal analgesic mechanisms include opioids, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, gabapentinoids, local anesthetics, and transversus abdominis plane block. Pre-treatment with gabapentin blocks the development of hyperalgesia and tactile allodynia for up to two days. The aim of this study is to evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores and total postoperative requirements of morphine and/or tramadol. In the preoperative period, consent is requested for patients who meet the inclusion criteria of the study. At this time it is verified whether gabapentin has been prescribed by the attending physician or not. If enrolled, the patient is allocated to the gabapentin group (Group A) or to the non-gabapentin group (Group B), according to his/her prescription.

All patients are monitored for electrocardiogram, pulse oximetry, noninvasive blood pressure, capnography, bispectral index (BIS®), and neuromuscular transmission with Train-of-Four (TOF®) during intraoperative period. Anesthesia is induced with intravenous fentanyl 1 to 3 µg/kg and propofol 1 to 3 mg/Kg. Muscle relaxation is achieved with rocuronium 0.5 to 1,2 mg/Kg and orotracheal intubation is performed when TOF count had reached 0. Anesthesia is maintained with Desflurane and Air/Oxygen, titrated to maintain the BIS value between 40-60. Muscle relaxation is maintained with rocuronium bolus (10mg), when more than two responses are detected in TOF stimulation. The lungs are mechanically ventilated and adjusted to maintain end-tidal carbon dioxide between 35 and 45 mmHg. All patients are given a continuous infusion of polyelectrolyte solution. At the end of surgery, neuromuscular block is antagonized with standard doses of sugammadex (2mg/Kg, if TOF≥2; 4mg/Kg if TOF=0 and Post-Tetanic-Count (PTC) ≥2; 16mg/Kg, if TOF=0 and PTC<2). The endotracheal tube is removed when the TOF ratio is > 90% and BIS > 80, with the patient being conscious, with adequate spontaneous ventilation and responded to verbal commands. Perioperative analgesia is provided with intravenous paracetamol 1g (administrated after anesthetic induction), parecoxib 40mg (administrated after anesthetic induction) and local anesthetic infiltration of trocar insertion sites with ropivacaine 0.5%. When gabapentin is preoperative given, the usual doses is 600mg. Postoperative nausea and vomiting prophylaxis are assured with intravenous dexamethasone 4mg after the induction, and intravenous ondansetron 4mg at the end of the surgery.

At the postanesthesia care unit (PACU), the pain is assessed using a numeric pain rating scale at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time). The investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Patients with sedation score of at least 4 are considered sedated. The occurrence of postoperative complications is also recorded. At any time, if analgesia is inadequate, the anesthesia resident will provide intravenous bolus of morphine (0.05-0.1 mg/Kg) and stop if patient has respiratory depression (defined as respiratory rate<10 per minute or Blood Oxygen Saturation (SpO2)<90% on air) or is sedated. Droperidol 0.625mg will be given intravenously if patient had persistent nausea or had two or more episodes of retching or vomiting. Total consumption of morphine during the stay at the PACU is recorded. - Post-operative analgesia is usually provided with intravenous paracetamol 1g 8/8h and intravenous parecoxib 40mg 12/12h. If the patient still complained of pain, then rescue analgesia will be given with intravenous tramadol 100mg, maximum 8/8h. Besides that, nausea and vomiting prophylaxis are assured with intravenous ondansetron 4mg 8/8h. Total consumption of tramadol during the stay at the ward is recorded.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A
In the Group A, a single-dose of 600mg gabapentin was used as part of a multimodal analgesic technique.
Drug: Gabapentin
One of the groups of patients was exposed to preoperative gabapentin. As the pain has a complex involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. In this case, some patients received gabapentin as a part of a multimodal analgesic technique.

Group B
In the group B gabapentin was not administered.



Primary Outcome Measures :
  1. Evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to postoperative pain scores, in five different time points. [ Time Frame: Postoperative pain is assessed at the arrival (0h) and then at 1, 6, 12, 24h, both at rest and at movement (with a maximum of 30minute variation at each evaluation time). ]
    Postoperative pain will be evaluated using the Numeric Pain Rating Scale (with minimum and maximum scores varying from 0 to 10, respectively, where 0 means no pain and the value 10 represents the worst imaginable pain). Investigators will also consult the nursing evaluation of pain scores (assessment of pain scores at intervals of 4hours). Higher values represent a worse outcome.


Secondary Outcome Measures :
  1. evaluate postoperative analgesic benefit in patients administered with 600mg oral gabapentin as premedication for laparoscopic cholecystectomy under general anesthesia, with respect to total postoperative requirements of morphine and/or tramadol. [ Time Frame: Total requirements of morphine and/or tramadol will be recorded during the first 24h of postoperative. ]
    Total postoperative consumption of morphine and/or tramadol will be recorded in milligrams.


Other Outcome Measures:
  1. The presence of postoperative complications, as somnolence, postoperative nausea and vomiting, dizziness, sedation and pruritus. [ Time Frame: The first 24h of postoperative. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective laparoscopic cholecystectomy in the "Centro Hospitalar do Porto".
Criteria

Inclusion Criteria:

  • Patients belonging to American Society of Anesthesiologists physical status I and II;
  • Patients undergoing elective laparoscopic cholecystectomy, under general anesthesia;
  • Age between 18 and 75 years;
  • Patients hemodynamically stable.

Exclusion Criteria:

  • Patients with an age older than 75 years or younger than 18 years;
  • Uncontrolled concomitant medical diseases (hypertension, bronchial asthma, diabetes mellitus);
  • Patients with history of chronic pain conditions;
  • Impaired kidney or liver function;
  • History of drug or alcohol abuse;
  • Occurrence of surgical complications that force a change in the established surgical approach;
  • Administration of analgesics within 24 hours of scheduled surgery;
  • Patients already on gabapentin or other anticonvulsants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583892


Contacts
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Contact: Serviço de Anestesiologia 00351222077549 secretariado.anestesia@chporto.min-saude.pt

Locations
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Portugal
Centro Hospitalar do Porto Recruiting
Porto, Portugal, 4099-001
Contact: Serviço de Anestesiologia         
Principal Investigator: Rita Saraiva, MD         
Sub-Investigator: Mariana Pinto, MD         
Sub-Investigator: Marta Pereira, MD         
Sub-Investigator: Catarina S. Nunes, PHD         
Sub-Investigator: Carla Cavaleiro, MD         
Sub-Investigator: Humberto Machado, PHD         
Sponsors and Collaborators
Centro Hospitalar do Porto
Investigators
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Principal Investigator: Rita Saraiva, MD Centro Hospitalar do Porto, Serviço de Anestesiologia
Additional Information:

Publications of Results:
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Responsible Party: Ana Rita Marques Saraiva, Rita Saraiva, Centro Hospitalar do Porto
ClinicalTrials.gov Identifier: NCT03583892    
Other Study ID Numbers: 2017 - 130 (111-DEFI/104-CES)
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Ana Rita Marques Saraiva, Centro Hospitalar do Porto:
Gabapentin, laparoscopic cholecystectomy, postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents