Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy

Pain, Postoperative Clinical Trial

Official title:

Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241875
• Other study ID #: Nakhli anesthesia sahloul
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2017
• Last updated: September 28, 2017
• Start date: December 1, 2016
• Est. completion date: September 28, 2017

Study information

• Verified date: September 2017
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 28, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic
• Pain, Postoperative
• Shoulder Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Tunisia	Sahloul Teaching Hospital	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

Country where clinical trial is conducted

Tunisia, 

References & Publications (3)

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 — View 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. Review. — View 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 D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative shoulder pain	Primary outcome is the intensity of shoulder pain during the first 48 hours after laparoscopic cholecystectomy using the visual analog scale (VAS).	VAS score with rest at 2h, 6h, 12h, 24h and 48 hours after surgery
Secondary	remifentanil consumption during anesthesia	Remifentanil requirements during anesthesia were calculated (µg/kg/mn)	one hour after tracheal tube removal
Secondary	Post operative sleep quality during the first night	Patient's sleep quality was assessed during the first postoperative night by the Spiegel score.	first night after surgery
Secondary	Post operative nausea and vomiting	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).	2, 6, 12, 24 and 48 hours after surgery.