Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
NCT ID: NCT03241875
Last Updated: 2017-10-02
Study Results
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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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2016-12-01
2017-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
Patients receive 2 capsules as placebo 2 hours before anesthesia. The capsules are delivered by the hospital pharmacy.
Placebo oral capsule
In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
pregabalin
patients receive 2 capsules of pregabalin (pregabalin 75), two hours before anesthesia.
Pregabalin 75mg
In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
gabapentin
patients receive 2 capsules of gabapentin (gabapentin 300), two hours before anesthesia.
Gabapentin 300mg
In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
Interventions
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Pregabalin 75mg
In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
Gabapentin 300mg
In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
Placebo oral capsule
In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) status \< 3
Exclusion Criteria
* conversion to open cholecystectomy
* history of epilepsia, psychiatric disorders and cognitive impairment
* Pregnancy and breastfeeding
* allergy to pregabalin and/or gabapentin
* Chronic pain
* Chronic medication by corticosteroids, neuroleptics or non steroidal anti inflammatory drugs
18 Years
65 Years
ALL
No
Sponsors
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Faculty of Medicine, Sousse
OTHER
Responsible Party
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Mohamed Said NAKHLI
MD, anesthesia and intensive care
Principal Investigators
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Mohamed Said Nakhli, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Sousse
Locations
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Sahloul Teaching Hospital
Sousse, , Tunisia
Countries
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References
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Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.
Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.
Nakhli MS, Kahloul M, Jebali C, Frigui W, Naija W. Effects of Gabapentinoids Premedication on Shoulder Pain and Rehabilitation Quality after Laparoscopic Cholecystectomy: Pregabalin versus Gabapentin. Pain Res Manag. 2018 Jul 9;2018:9834059. doi: 10.1155/2018/9834059. eCollection 2018.
Other Identifiers
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Nakhli anesthesia sahloul
Identifier Type: -
Identifier Source: org_study_id