Intrathecal Administration of Levobupivacaine and Opioids in Elderly

NCT02385539 | Completed

• 1 other identifier: JPAVSAR
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

To find the optimal dose and combination of small dose of Levobupivacaine (LB) coadministered intrathecally with Fentanyl (F) or Sufentanil (S) with the highest probability for not developing hypotension and the lowest opioid side effect that would be sufficient to achieve and maintain a sensory block to the tenth thoracic dermatoma (T10) in elderly patients for surgery lasting \> 45 minutes as compared with large dose of Levobupivacaine alone.

Conditions

Adverse Reaction to Spinal Anesthetic

Outcome Measures

Primary Outcomes (1)

• Optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil in elderly patients

  To find an optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil with the highest probability of not developing the hypotension as well as with the lowest opioid side effect that would be potent enough in achieving and maintaining a sensory block at T10 level for surgery lasting more than 45 minutes in elderly patients. Binary logistic regression will be performed to assess the impact of a number of factors on the likelihood that patients may not develop hypotension. The model will consists of 10 independent variables (dose and combination of levobupivacaine with Fentanyl or Sufentanil, age, basal SBP, basal MAP, time to lowest spinal SBP, upper limit of sensory block, time until two-segment regression, time until T12 regression, time until S1 regression, BMI).

  9 months

Study Arms (3)

Levobupivacaine (LB) 6 mg

ACTIVE COMPARATOR

Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 6 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB6F25 (LB 6 mg, Fentanyl 25 mcg), LB6F35 (LB 6 mg, Fentanyl 35 mcg), LB6S5 (LB 6 mg, Sufentanil 5 mcg), LB6S7 (LB 6 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered

Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.

Levobupivacaine (LB) 8 mg

ACTIVE COMPARATOR

Patients will be stratified into three groups (80 patients) according to doses of Levobupivacaine (6, 8 or 12 mg, Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients who will receive 8 mg of Levobupivacaine will be randomized to one of four treatment groups (each 20 patients), by dose of intrathecal opioids: 25, 35 mcg of Fentanyl (Fentanyl, Janssen Cilag, amp. 50 mcg/ml) or 5, 7 mcg of Sufentanil (Sufenta, Janssen-Pharmaceutica, amp. 5 mcg/ml). The groups will be named according to dose and combination of Levobupivacaine and Fentanyl or Sufentanil that will be given intrathecally as LB8F25 (LB 8 mg, Fentanyl 25 mcg), LB8F35 (LB 8 mg, Fentanyl 35 mcg), LB8S5 (LB 8 mg, Sufentanil 5 mcg), LB8S7 (LB 8 mg, Sufentanil 7 mcg). Hemodynamic and opioid's side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered

Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.

Levobupivacaine (LB) 12 mg

PLACEBO COMPARATOR

Patients will be stratified into three groups by 80 patients: those who will receive 6, 8 or 12 mg of Levobupivacaine intrathecally (Chirocaine, Abbot Laboratories, amp. 5 mg/ml). Patients will receive 12 mg of Levobupivacaine alone intrathecally. Hemodynamic side effects will be recorded after intrathecal injection. The level and duration of sensory block, time until two-segment regression, T12 regression andl full skin sensory sensibility at the S1 segment will be registered

Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.

Interventions

The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection. DRUG

The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection.

Also known as: levobupivacaine

Levobupivacaine (LB) 12 mg; Levobupivacaine (LB) 6 mg; Levobupivacaine (LB) 8 mg

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• male patients
• ASA II-III undergoing elective urological (transuretheral or transvesical prostatectomy, hydrocelectomy, orchiectomy) or lower abdominal (inguinal herniorrhaphy) surgery under spinal anesthesia requiring a sensory block to at least the tenth thoracic dermatoma, lasting \>45 minutes.

You may not qualify if:

• severe systemic disorders
• patients unwilling to accept regional anesthesia
• patients who will develope sensory block level lower than T10 dermatoma after intrathecal injection
• patients with an abnormal coagulation profile or with significant pulmonary disease (reactive airway disease or chronic obstructive pulmonary disease requiring daily bronchodilator or steroid use and/or room air oxygen saturation \<95% immediately before surgery).

Sponsors & Collaborators

• Šarić, Jadranka Pavičić, M.D.: lead

Study Sites (1)

University Hospital Merkur

Zagreb, Croatia, 10000, Croatia

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jadranka Pavičić Šarić, PhD

  University Hospital Merkur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 11, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

CR (1)