Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorrectal Surgery

Colorectal Surgery Clinical Trial

— OFA_GAL_21  

Official title:

Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorrectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887258
• Other study ID #: 2021-003245-38
• Status: Recruiting
• Phase: Phase 3
• Start date: May 15, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: May 2023
• Source: Osakidetza
• Contact: Unai Ortega, MD
• Phone: 944007000
• Email: unai.ortegamera[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare opioid free anesthesia versus opioid anestheisa in patients undergo laparoscopic colorrectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery.

Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).

The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.

Description:

The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated.

Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.

Other variables evaluated will be postoperative complications:

• Postoperative hypoxemia.

• Incidence of postoperative nausea and vomiting (PONV).

• Postoperative ileus.

• surgical complications.

• medical complications

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

( - ) Patients older than or equal to 18 years.

(-) Patients scheduled for laparoscopic colorectal surgery.

(-) Patients with physical status classification (ASA) I-III.

(- ) Patients who have signed the informed consent of the clinical trial

Exclusion Criteria:

(-) Pregnant or lactating patients.

(-)Patients with allergy to any of the drugs or excipients used in the study

(-) Emergency laparoscopic colorectal surgery

(-) Patients with AV block, intraventricular block, or sinus block

(-) Adam-Stokes syndrome.

(-) Patient on chronic beta-blocker treatment with HR < 50 bpm

(-) Patient with ejection fraction < 40% known

(-) Epilepsy.

(-) Surgery converted to open surgery

(-) Legally disabled patient

(-) Patients with physical status classification (ASA) IV.

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• Opioid free anesthesia
Administer a combination of drugs in substitution for morphine

Locations

Country	Name	City	State
Spain	Hospital de Galdakao	Galdakao	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
Unai Ortega Mera	Osakidetza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative Security	Presentation of complications during the surgical intervention defined as a situation that requires immediate action by the anesthetist and lasts more than 30 minutes, the interruption of the operation and/or conversion to open surgery.	1 day
Other	postoperative security	Operative hypoxemia defined as oxygen saturation by pulseoximetry less than 90% Incidence of Postoperative Nausea and Vomiting (PONV) during de first 3 days Postoperative ileus defined as the absence of bowel movements during the first 3 days	3 day
Primary	Pain control	milligrams of opioids required postoperatively during the first 3 of admission	3 days
Secondary	VNS score	Pain measured through the visual analogue scale (VAS) during the first 3 days of admission	3 days
Secondary	morphine rescues	Number of opiate rescues required during the postoperative period	7 days