Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).

Obesity Clinical Trial

Official title:

The Effect of Preemptive Oral Pregabalin as an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized, Prospective, Double Blind Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804591
• Other study ID #: PreGab LSG
• Status: Recruiting
• Phase: Phase 4
• Start date: April 24, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2023
• Source: Medical University of Warsaw
• Contact: Piotr Mieszczanski, MD
• Phone: 669643205
• Email: piotr.mieszczanski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. The participants will be divided into 2 groups: with or without preemptive pregabalin administration.

Description:

Pregabalin is a GABA analogue that has analgesic, anxiolytic and effects. There are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. Such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery. The investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
• Written informed consent

Exclusion Criteria:

• Patient's refusal
• Known allergies to study medication
• Inability to comprehend or participate In pain scoring scale
• Inability to use intravenous patient controlled analgesia
• Changes of operation extent during procedure
• Revisional operations
• End stage organ failure

Related Conditions & MeSH terms

• Obesity
• Opioid Use
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

Drug:
• Pregabalin 150mg
Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.
• Placebo
1 capsule containing placebo per os 1 hour before start of the operation.

Locations

Country	Name	City	State
Poland	Szpital Kliniczny Dzieciatka Jezus	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative oxycodone consumption	PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes	Day "0"
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 1 hour after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 6 hour after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 12 hour after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 24 hour after operation
Secondary	Postoperative sedation score	1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Postoperative nausea and vomiting	Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Highest BP	Highest BP during operation	intraoperative
Secondary	Lowest BP	Lowest BP during operation	intraoperative
Secondary	Highest HR	Highest HR during operation	intraoperative
Secondary	Lowest HR	Lowest HR during operation	intraoperative
Secondary	Total ephedrine dosis	Ephedrine is a vasopressor used in case of hypotension to maintain mean arterial pressure > 65 mmHg or to increase blood pressure to check surgical hemostasis	intraoperative
Secondary	Postoperative desaturation	SpO2 < 94%	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Blurred vision	Presence of blurred or abnormal vision	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Patient's comfort assessed in QoR-40 formulary	QoR-40 (Quality of Recovery) scale is used to measure the quality of recovery after surgery and anesthesia, it is a 40 item questionnaire that provides a score across five dimensions: patient support, comfort, emotions, physical independence, and pain. Formulary will assess first 24 hours following the operation. Maximal score is 200, higher result is associated with better quality of recovery.	Day "0", assessed 24 hours after operation
Secondary	Postoperative oxycodone consumption	PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes	Day "0", assessed 1,6,12 and 24 hours after operation