Pain, Postoperative, Cholecystectomy, Laparoscopic
Conditions
Keywords
pregabalin, gabapentin, post operative pain, laparoscopic cholecystectomy
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.
Interventions
DRUGPregabalin 75mg
In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
DRUGGabapentin 300mg
In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
DRUGPlacebo oral capsule
In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
Sponsors
Faculty of Medicine, Sousse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative shoulder pain | VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery | Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| remifentanil consumption during anesthesia | one hour after tracheal tube removal | Remifentanil requirements during anesthesia were calculated (µg/kg/mn) |
| Post operative sleep quality during the first night | first night after surgery | Patient's sleep quality was assessed during the first postoperative night by the Spiegel score. |
| Post operative nausea and vomiting | 2, 6, 12, 24 and 48 hours after surgery. | The intensity of post operative nausea and vomiting was assessed by a 0 to 3 score (0: no nausea or vomiting, 1: slight mild nausea, 2: moderate nausea, 3: vomiting). |
Countries
Tunisia
Outcome results
None listed