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Anorectal DiseasesNCT05409820

Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery

An observational study of Anorectal Diseases and Hemorrhoids, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spinal anesthesia for anorectal surgery ( fistulotomy, fissure repair, pilonidal sinus excision,hemorrhoidectomy..) is a popular and widely used method characterized by rapid onset, delivery, easy mobilization and short hospital history. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anorectal Diseases, Hemorrhoids, Anal Polyp
What is being tested?
use of different spinal anesthesia techniques
Type of treatment
Surgery or procedure
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2022to 1 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients

Who may be able to join

  • Both sexes undergoing anorectal surgery, 18-65 years old, ASA score 1-2 patients

Who cannot join

  • be under the age of 18
  • be over 65
  • ASA score of 3 and greater than 3
  • patients with fever
  • those who are pregnant
  • Patients with kidney failure
Show all 16Show fewer
  • Patients with hepatic insufficiency
  • Patients with heart failure
  • Patients with upper respiratory tract symptoms
  • Patients with coagulation disorders
  • Patients with infection in the lumbar region
  • Patients with BMI <18 and BMI >40
  • Patients with uncontrolled hypertension, diabetes, pheochromocytoma and thyroid dysfunction
  • Those who do not have the ability to read, write or understand the consent form
  • Patients who do not want to sign the consent form
  • Patients deemed unsuitable by the investigator

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Comparative Analysis of Hypobaric Versus Hyperbaric Bupivacaine for Spinal Anesthesia in Day-Case Anorectal Surgery: Efficacy, Safety, and Discharge Times

Spinal anesthesia for anorectal surgery ( fistulotomy, fissure repair, pilonidal sinus excision,hemorrhoidectomy..) is a popular and widely used method characterized by rapid onset, delivery, easy mobilization and short hospital history. In order to minimize complications after spinal anesthesia, the use of lower-dose local anesthesia with the saddle block method has recently become widespread. Bupivacaine is often used for this method. Bupivacaine can be used hypobaric or hyperbaric in spinal anesthesia.

Early mobilization and early discharge are important and necessary in an anorectal disease group that has such a high incidence and does not require rapid surgery and postoperative follow-up and hospitalization.Outpatient surgery is a very suitable surgical procedure for anorectal surgeries.

In the light of all this information, the aim of this study is to evaluate and observe the hemodynamic data, bromage scores, mobilization and discharge of patients who underwent spinal anesthesia with two different techniques.

Read the detailed description

In this study, it is aimed to reduce long hospital stays and postoperative complications by comparing the postoperative mobilization, urination and discharge times of the patients after spinal anesthesia using 5mg hypobaric and 5 mg hyperbaric bupivacaine in patients who will undergo outpatient anorectal surgery.

After the approval of the ethics committee in the operating room of the Ankara City Hospital, 68 patients who will undergo day surgery due to anorectal disease will be included in the study. This study was planned as observational.

Both genders, American society of anesthesiology(ASA) score 1-2, 68 patients between the ages of 18-65 will be included in the study. The patients will be evaluated in 2 groups of 34 people.

Patients with routine preoperative preparation, ECG, Spo2( oxygen saturation) and non-invasive blood pressure monitoring in the operating room and throughout the study will be included. Written informed consent will be obtained from patients.

ECG, Spo2 and noninvasive blood pressure monitoring of the patients who are taken back to the hospitalization service for postoperative follow-up after the operation will continue. Patients will be followed up with:

half-hourly intervals, first analgesic requirement, urination, mobilization times.

If there are no complications, the patients will be discharged. The next day, patients will be called and questioned in terms of spinal anesthesia-related complications (headache, low back pain, urinary dysfunction…) and their anesthetic satisfaction will be noted.

A total of minimum 68 (n1=34, n2=34) patients with effect size d=0.80, α=0.05 were found to be sufficient for 90% power in the sample size calculation.

Parameters to look at:

Operation time Intraoperative and postoperative vital monitoring need for sedation Time of sensory block to reach s4 dermatome The highest dermatome reached by sensory block Loss time of sensory block Modified bromage scale (5 minutes after spinal cord, end of operation, 1 postoperative 15 minutes, time to zero value) Time to first postoperative analgesic requirement Postoperative urination time Postoperative mobilization time Presence of complications related to spinal anesthesia patient satisfaction.

Being tested
use of different spinal anesthesia techniques
Keywords
Day-case Surgery, Spinal Anesthesia, Anorectal Surgery
Medical subject headings
Rectal Diseases, Hemorrhoids, Pilonidal Sinus, Fissure in Ano

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • use of different spinal anesthesia techniquesProcedure or surgery

    Comparison of spinal anesthesia with 5 mg hypobaric bupivacaine and 5 mg hyperbaric bupivacaine in outpatients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discharge Time

    to determine the time at which patients are ready for discharge

    Measured: 1 day after surgery

Secondary outcomes (12)

  1. Modified Bromage Scale

    to determine the amount of motor function

    Measured: 5 minutes after spinal anesthesia End of the surgery (up to 1 hour) Postoperative 15 minutes Postoperative 30 minutes Postoperative 45 minutes Postoperative 60 minutes

  2. Time Of First Analgesic Need

    to measure when the pain started

    Measured: 1 day after surgery

  3. Urination Time

    to determine the presence of urinary dysfunction

    Measured: 1 day after surgery

  4. Mobilization Time

    with a modified bromage scale of zero and able to walk unaided

    Measured: 1 day after surgery

  5. Postoperative Complication

    presence of headache, urinary dysfunction, postoperative nausea and vomiting

    Measured: 1 day after surgery

  6. Blood Pressure

    systolic, diastolic and mean arterial pressure,to determine the hemodynamic effects of spinal anesthesia

    Measured: it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour

  7. Heart Rate

    to determine the hemodynamic effects of spinal anesthesia

    Measured: it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour

  8. Spo2

    to determine the hemodynamic effects of spinal anesthesia

    Measured: it is registered in entry, intraop 5.minutes,10.minutes,15.minutes, 20.minutes, 25.minutes, 30.minutes, 35.minutes, 40.minutes, 45.minutes, 50.minutes, 55.minutes,60. minutes ,postoperative 1st hour ,postoperative 2nd hour,postoperative 3rd hour

  9. Number of Participants with Sedation Need

    to determine whether sufficient sensory block has occurred

    Measured: intraoperative, during surgery

  10. The Highest Dermatome Reached By The Sensory Block

    to determine whether sufficient sensory block has occurred

    Measured: intraoperative

  11. S4 Dermatome Sensory Blockage Time

    to determine the time it takes for adequate sensory block to occur for surgery

    Measured: preoperative, intraoperative

  12. Time to Disappearance of Sensory Block

    to calculate the duration of the effect of spinal anesthesia

    Measured: 1 day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Jul 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409820
Sponsor's protocol ID
ACH-YALNİZ-001
Status last verified
Jul 2024
First submitted
17 Apr 2022
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Honca M, Dereli N, Kose EA, Honca T, Kutuk S, Unal SS, Horasanli E. Low-dose levobupivacaine plus fentanyl combination for spinal anesthesia in anorectal surgery. Braz J Anesthesiol. 2015 Nov-Dec;65(6):461-5. doi: 10.1016/j.bjane.2014.01.007. Epub 2014 Feb 20.

    PubMed 26614142

  • Taspinar V, Sahin A, Donmez NF, Pala Y, Selcuk A, Ozcan M, Dikmen B. Low-dose ropivacaine or levobupivacaine walking spinal anesthesia in ambulatory inguinal herniorrhaphy. J Anesth. 2011 Apr;25(2):219-24. doi: 10.1007/s00540-010-1089-9. Epub 2011 Jan 12.

    PubMed 21225292

Questions about this trial

What is this clinical trial studying?

An observational study of Anorectal Diseases and Hemorrhoids, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discharge Time (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409820, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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