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

The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01880775
Enrollment
50
Registered
2013-06-19
Start date
2012-04-30
Completion date
2013-07-31
Last updated
2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoid, Peri Anal Fistula

Brief summary

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.

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.

Interventions

experimental

DRUGBupivacaine

marcaine heavy 0.5% 7.5 mg intrathecal

Sponsors

Diskapi Teaching and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* ASA status I-III

Exclusion criteria

* Patients with contraindications for spinal anesthesia, * hypersensitivity to study drugs

Design outcomes

Primary

MeasureTime frameDescription
Sensory block regression at S3 (time, minute)postoperative 30. minutespinal anesthesia

Secondary

MeasureTime frameDescription
discharge time (minute)postoperative 2 hourspinal anesthesia

Other

MeasureTime frameDescription
Regression of motor blockPostoperative second hourBromage scale will be used 0: no motor block, 1: hip blocked, 2: hip and knee blocked, 3: hip, knee and ankle blocked
Maximum block heightIntraoperative 30 minutesMaximum spread of the sensorial block
Time to T10 blockIntroperative 10 minuteloss of sensation to pinprick
Time to L1 blockIntraoperative 5 minutesLoss of sensation to pin prick
Motor blockIntraoperative 30 minutes and postoperative first hourBromage scale will be used 0: no motor block, 1: hip blocked, 2: hip and knee blocked, 3: hip, knee and ankle blocked

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026