Clinical trial NCT03241875: Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
Official title: Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Cholecystectomy, Laparoscopic
Keywords: pregabalin
gabapentin
post operative pain
laparoscopic cholecystectomy
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of premedication with pregabalin or gabapentin versus placebo on postoperative shoulder pain after laparoscopic cholecystectomy.

Detailed description: Preoperative premedication with gabapentins reduces preoperative anxiety, stress response to surgical stimuli, decreases anesthetic use. The incidence of postoperative nausea and vomiting appears to be decreased. The other desired effect of gabapentins is the reduction in the intensity of postoperative pain after laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* uncomplicated laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) status \< 3

Exclusion Criteria:

* acute cholecystitis
* 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

Primary outcomes:
measure: Post operative shoulder pain
timeFrame: VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Secondary outcomes:
measure: remifentanil consumption during anesthesia
timeFrame: one hour after tracheal tube removal
measure: Post operative sleep quality during the first night
timeFrame: first night after surgery
measure: Post operative nausea and vomiting
timeFrame: 2, 6, 12, 24 and 48 hours after surgery.
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Sahloul Teaching Hospital
Study officials:
affiliation: Faculty of Medicine, Sousse
name: Mohamed Said Nakhli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.