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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02322372
Other study ID # 30/06/2014
Secondary ID
Status Completed
Phase Phase 4
First received December 13, 2014
Last updated February 15, 2015
Start date July 2014
Est. completion date December 2014

Study information

Verified date February 2015
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period


Description:

Fifty patients undergoing arthroscopic meniscus repair were included to the current study.

The patients were allocated to two groups as the spinal anesthesia with conventional dose of heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral blockade.

Blood pressures and heart rates were recorded at the beginning, at the 0th minute following femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for 20 minutes and in five-minute intervals till the end of surgery.

The sensorial block and motor block in both extremities were recorded in two-minute intervals following spinal anesthesia and in five-minute intervals till the end of surgery The time of sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to reach maximum level of sensorial blockade and the time for regression of sensorial blockade to L2, the time for regression of motor blockade were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair

Exclusion Criteria:

- Contraindications to regional anesthesia (coagulopathy, severe aortic stenosis, sever mitral stenosis, increased intracranial pressure, severe hypovolemia, presence of infection on the site of injection)

- Presence of previous spinal surgery

- Presence of diabetes mellitus

- Presence of neurological disturbance

- Uncooperated patients, patients not accepting to participate the study

- Allergy to study drugs

- ASA II-IV patients, BMI >38, Height < 150 cm and >190 cm

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Femoral blockade
Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine
Intrathecal anesthesia
Spinal anesthesia with heavy bupivacaine

Locations

Country Name City State
Turkey Ankara University Medical School Anesthesiology and ICU Department Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of sensorial block to regress L2 24 hours Yes
Secondary Time of first analgesic requirement 24 hours Yes
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