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Evaluation of the effect of venous anesthesia during Gallbladder Removal Surgery on pain intensity and acute inflammatory response

Evaluation of the effect of intraoperative venous Lidocaine on pain intensity and plasma interleukin-6 (IL-6) concentration in patients undergoing Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-48wwhsw
Enrollment
Unknown
Registered
2023-10-10
Start date
2020-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy Laparoscopy

Interventions

This is a clinical, prospective, randomized and double-blind trial, carried out at Hospital São Domingos, located in São Luís - MA. The study population comprised 60 patients, aged > 18 years, who und

Sponsors

Hospital São Domingos
Lead Sponsor
Hospital São Domingos
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, ASA I-III, of both genders, who underwent videolaparoscopic cholecystectomies were included in the study.

Exclusion criteria

Exclusion criteria: Patients who had cardiac arrhythmias, dilated cardiomyopathy, cardiac conduction disorders, electrolyte disorders, acid-base disorders, hypersensitivity to lidocaine, psychiatric, liver, respiratory or oncological diseases, who had been receiving any type of analgesic in the previous week were excluded from the study, surgery and those who received blood products during the study period.

Design outcomes

Primary

MeasureTime frame
Expected outcome I: It is expected to find a decrease in pain intensity from 30 minutes to 12 hours postoperatively, verified using the pain analogue scale, based on the verification of a variation of at least 2 points in the comparative measurements between the two groups.;Expected outcome II:It is expected to find a decrease in the consumption of analgesia by patients in the postoperative period, verified through the analysis of 3 variables: first dose of morphine administered (in minutes), dose of morphine administered (in mg) and use of morphine, the from the verification of a p value <0.05 in the statistical comparison between the groups.

Secondary

MeasureTime frame
Outcome found I: Regarding pain assessment, the study found a difference between the groups, with statistical significance, at times T0 (30 minutes after extubation) and T1 (1 hour after extubation), with p value <0.001. It is also worth mentioning that the maximum level of pain intensity recorded at T0, by the Control Group, was three times compared to the Lidocaine Group. In T1, however, it was 5 points higher, which demonstrates the lower intensity of pain in this immediate postoperative period. In the other evaluation times, there was no statistically significant difference between the groups.;Outcome found II: A decrease was observed in relation to the first dose of morphine administered between the two groups. The dose of morphine administered (in mg) also showed reduction, with the maximum dose administered in the Control Group ([0-8] mg) was quadruple in relation to the maximum of the Lidocaine Group ([0-2] mg); . Regarding the use of morphine, patients in the Lidocaine Group used less morphine in the first 12 hours, demonstrating a statistical difference (p<0.05).

Countries

Brazil

Contacts

Public ContactVitor Rios

Hospital São Domingos

vitorriosjudo@hotmail.com+55 (98) 3216-8100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)