Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Tramadol-abuse Patients

Analgesia Clinical Trial

Official title:

Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445857
• Other study ID #: IRB 6379
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Increasing duration of local anesthetic action is desired for prolongation of postoperative patient comfort, as well as decreasing perioperative opioid consumption and subsequent side effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically increased in Egypt since 2008 and has led to many admissions to addiction treatment centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much shorter in chronic opium abusers compared with non-abusers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with history of substance use disorders (SUD) history of tramadol addiction (single drug addiction and substances used besides tramadol) and duration of addiction >1 year

• Elective lower abdomen or lower extremities surgeries under spinal anesthesia

• ASA physical status I and II

Exclusion Criteria:

• Patient's refusal,

• duration of surgery more than 120 min,

• obesity with body mass index (BMI) >35 kg/m2,

• generalized infection or localized infection at level of blockade,

• neurological disease,

• psychological disorder

• coagulation disorder,

• history of uncontrolled hypertension,

• history of uncontrolled blood sugar,

• allergy to bupivacaine or calcitonin

• or failed spinal.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)
coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.

Other:
• normal saline (NS)
1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.

Locations

Country	Name	City	State
Egypt	Ibrahim Mamdouh Esmat	Cairo	Married

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.	The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.	procedure