Methadone Anesthesia For Kidney Transplant Receptors

Surgery Clinical Trial

Official title:

Intraoperative Use Of Methadone In The Prevention of Postoperative Pain in Kidney Transplant Receptors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908345
• Other study ID #: MEFERENAL
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2021
• Est. completion date: January 2022

Study information

• Verified date: May 2021
• Source: University of Sao Paulo General Hospital
• Contact: Felipe C Machado, MD, PhD
• Phone: +551126616335
• Email: felipe.chiodini[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intraoperative methadone or fentanyl will be administered to patients submitted to kidney transplant surgery. Postoperative pain, analgesic consumption and side effects will be evaluated

Description:

Despite recent developments in postoperative pain control, many patients still experience moderate or severe pain after surgery. It is estimated that severe postoperative pain occurs in 20 to 40% of surgical procedures. With the development of kidney transplant services, a better study of the intraoperative analgesia used in this procedure and its impact on the postoperative is necessary. The management of postoperative pain in renal transplant recipients is essential to improve the quality of postoperative care, and may even impact the prognosis of the renal graft. One of the strategies to improve pain control in the perioperative period is the intraoperative use of intravenous methadone, given its pharmacokinetic profile. Methadone is an opioid agonist of µ receptors, it is also a Glutamate antagonist by blocking the N-methyl-D-aspartate (NMDA) receptor, and inhibits the reuptake of serotonin and norepinephrine. When administered in doses of 20 to 30mg, the analgesia generated by methadone can last from 24 to 36 hours. There is also evidence that the use of methadone in doses of 0.2 to 0.3 mg / kg is not associated with a higher incidence of side effects when compared to other opioids with short or intermediate duration of action, such as fentanyl, sufentanil and morphine. The aim of this study is to evaluate the effectiveness of using intraoperative methadone to reduce postoperative pain in patients undergoing kidney transplant surgery (recipients). Patients will be submitted to standardized general anesthesia, and the opioid used in anesthetic induction will be methadone or fentanyl with additional boluses if necessary. After extubation, Fentanyl will be installed in an intravenous analgesia pump controlled by the patient. Differences between groups regarding opioid consumption, pain scores, side effects and patient satisfaction will be assessed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age
• With indication for kidney transplant surgery
• Who sign the informed consent form

Exclusion Criteria:

• Patients who refuse to participate in the study
• Known allergy to any drug used in this protocol
• Presence of stage III or IV congestive heart failure
• Increase in QT interval on electrocardiogram (QT> 500 msec)
• Preemptive kidney transplantation (defined by transplantation in a patient who has not yet started kidney replacement therapy).

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic
• Surgery

Intervention

Drug:
• Methadone
Used at induction and during surgery
• Fentanyl
Used at induction and during surgery

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score 24h postoperatively	Reported pain in a scale of 0 (no pain) to 10 (maximum pain)	One day after surgery
Primary	Pain score 48h postoperatively	Reported pain in a scale of 0 (no pain) to 10 (maximum pain)	Two days after surgery
Primary	Pain score 72h postoperatively	Reported pain in a scale of 0 (no pain) to 10 (maximum pain)	Three days after surgery
Primary	Analgesic use 24h postoperatively	Analgesic use after surgery	One day after surgery
Primary	Analgesic use 48h postoperatively	Analgesic use after surgery	Two days after surgery
Primary	Analgesic use 72h postoperatively	Analgesic use after surgery	Three days after surgery
Secondary	Opioid-related side effects 24h postoperatively	Opioid-related side effects	One day after surgery
Secondary	Opioid-related side effects 48h postoperatively	Opioid-related side effects	Two days after surgery
Secondary	Opioid-related side effects 72h postoperatively	Opioid-related side effects	Three days after surgery