Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy

NCT03583892 | Unknown FDA Drug

• 1 other identifier: 2017 - 130 (111-DEFI/104-CES)
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Gabapentin, laparoscopic cholecystectomy, postoperative pain

Outcome Measures

Primary Outcomes (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.

  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.

  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).

Secondary Outcomes (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.

  Total requirements of morphine and/or tramadol will be recorded during the first 24h of postoperative.

Other Outcomes (1)

• The presence of postoperative complications, as somnolence, postoperative nausea and vomiting, dizziness, sedation and pruritus.

  The first 24h of postoperative.

Study Arms (2)

Group A

In the Group A, a single-dose of 600mg gabapentin was used as part of a multimodal analgesic technique.

Drug: Gabapentin

Group B

In the group B gabapentin was not administered.

Interventions

Gabapentin DRUG

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 A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic cholecystectomy in the "Centro Hospitalar do Porto".

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

RECRUITING

Related Publications (1)

• Srivastava U, Kumar A, Saxena S, Mishra AR, Saraswat N, Mishra S. Effect of preoperative gabapentin on postoperative pain and tramadol consumption after minilap open cholecystectomy: a randomized double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 Apr;27(4):331-5. doi: 10.1097/EJA.0b013e328334de85.

  PMID: 19935070 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rita Saraiva, MD

  Centro Hospitalar do Porto, Serviço de Anestesiologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serviço de Anestesiologia

CONTACT

00351222077549; secretariado.anestesia@chporto.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rita Saraiva

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 12, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)