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Discharge Conditions of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ozden Gorgoz Kaban, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01880775
First received: March 12, 2012
Last updated: June 2, 2014
Last verified: March 2012
  Purpose

In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.


Condition Intervention Phase
Hemorrhoid
Peri Anal Fistula
Drug: Prilocaine
Drug: Bupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • Sensory block regression at S3 (time, minute) [ Time Frame: postoperative 30. minute ] [ Designated as safety issue: No ]
    spinal anesthesia


Secondary Outcome Measures:
  • discharge time (minute) [ Time Frame: postoperative 2 hour ] [ Designated as safety issue: No ]
    spinal anesthesia


Other Outcome Measures:
  • Maximum block height [ Time Frame: Intraoperative 30 minutes ] [ Designated as safety issue: No ]
    Maximum spread of the sensorial block

  • Motor block [ Time Frame: Intraoperative 30 minutes and postoperative first hour ] [ Designated as safety issue: No ]
    Bromage scale will be used 0: no motor block, 1: hip blocked, 2: hip and knee blocked, 3: hip, knee and ankle blocked

  • Regression of motor block [ Time Frame: Postoperative second hour ] [ Designated as safety issue: No ]
    Bromage scale will be used 0: no motor block, 1: hip blocked, 2: hip and knee blocked, 3: hip, knee and ankle blocked

  • Time to L1 block [ Time Frame: Intraoperative 5 minutes ] [ Designated as safety issue: No ]
    Loss of sensation to pin prick

  • Time to T10 block [ Time Frame: Introperative 10 minute ] [ Designated as safety issue: No ]
    loss of sensation to pinprick


Enrollment: 50
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prilocaine heavy 2%& fentanyl
prilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal
Drug: Prilocaine
experimental
Other Names:
  • prilothecal
  • citanest
Active Comparator: bupivacaine heavy 0.5% & fentanyl
bupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal
Drug: Bupivacaine
marcaine heavy 0.5% 7.5 mg intrathecal
Other Name: marcaine heavy 0.5%

Detailed Description:

ASA status I-III patients will be recruited. Patients will be randomized in two groups. Group B will be received 1.5 ml heavy bupivacaine+ 20 mic fentanyl+ 0.15 ml and Group P will be received 1,5 ml heavy prilocaine+20 mic fentanyl in the same volume.Patients will be monitored with electrocardiography, peripheral oxygen saturation(sPO2) and non invasive blood pressure (Drager Infinity Delta; 16 Electronics Avenue, Danvers, MA 01923 USA). After inserting a 20 G intravenous line the patients will be hydrated with 10 ml/kg 0.9 % saline.

Preoperative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR) and Spo2 will be measured and recorded.

Spinal anesthesia will be commenced in the sitting position with a 25 G Quincke needle, with the midline approach. After observing free flow of cerebrospinal fluid the prepared study drug will be injected in 15 seconds. The patients will be placed supine after waiting 2 minute in the sitting position. Supplemental oxygen via nasal cannula will be provided.

Fentanyl and midazolam will be used for rescue analgesia and sedation and recorded.

Sensorial block will be assessed with pinprick test with 2 minute intervals until the maximum block achieves and with 15 minute intervals until the block was regresses to S3 dermatome. Motor block will be assessed with the Bromage score when the block reached the maximum level. Patients will be transferred to postoperative care unit (PACU) at he end of surgery.

Pain will be assessed on a 10 point visual analog scale (VAS)(0= no pain, 10= worst pain ever). Postoperative analgesia will be provided with 2 mg.kg-1 tramadol or 15 mg.kg-1 paracetamol when the VAS score is ≥3 time of first analgesic request will be recorded.

Hypotension (≥20% reduced from baseline values) will be treated with ephedrine or iv fluid boluses), bradycardia (HR<45 beat min-1 was treated with atropine) was recorded.

The patients will be asked whether to void before surgery. Bladder volume will be assessed with ultrasonography. Patients with residual bladder volumes ≥400 ml will be placed an urine catheter. Time to first urinate will be recorded.

Patients will be assessed for transient neurologic symptoms(pain in the buttocks and legs)(TNS) and satisfaction after surgery.

TNS will be evaluated with daily telephone calls. Patient satisfaction will be evaluated with global satisfaction scale (1= bad, 2=not satisfied, 3=have no idea, 4=satisfied, 5=very satisfied) Parameters to record; time of entering operation room, duration of surgery, time of intrathecal injection, onset of sensorial block(block at L1), time to reach maximum block level, maximum block level, first analgesic ingestion time, PACU duration, two segment regression, time to L1 regression, time to S3 regression, time to it without help, time to stand up without help, time to walk without help, discharge time, time to first void. TNS, patient satisfaction score.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status I-III

Exclusion Criteria:

  • Patients with contraindications for spinal anesthesia,
  • hypersensitivity to study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01880775

Locations
Turkey
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, Turkey, 06110
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Study Director: Taylan Akkaya, Assoc Prof. Netherlands: Ministry of Health, Welfare and Sports
  More Information

Publications:
Responsible Party: Ozden Gorgoz Kaban, Medical Doctor Trainee in Anesthesiology and Reanimation, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01880775     History of Changes
Other Study ID Numbers: OKabanPrilocain
Study First Received: March 12, 2012
Last Updated: June 2, 2014
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases
Bupivacaine
Fentanyl
Prilocaine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014