An interventional study of Group I: Lower Volume with Higher Anaesthetic Concentration and Group II: Higher Volume with LowerAnaesthetic Concentration in Analgesia, sponsored by Ataturk University. Recruiting at 1 site in Turkey. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Ataturk University · Not applicable, Interventional, and Treatment
It is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.
This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 54 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients will be given 10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Level of sensory block will be tested by testing with ice from S2 dermatome cephally. Analgesia will be maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution.
Procedure: Group I: Lower Volume with Higher Anaesthetic Concentration
The patients will be given 20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether. Analgesia will be maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. In addition, patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered. "Breakthrough pain" that requires even further analgesia will be treated with an epidural bolus of 5 ml of 0,125% bupivacain solution.
Procedure: Group II: Higher Volume with LowerAnaesthetic Concentration
10 ml of a solution containing 0,1% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural (PIE) boluses of 7,5 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered
20 ml of a solution containing 0,0625% of bupivacaine and 2 mcg/ml fentanyl through the epidural cathether, maintained by programmed intermittant epidural boluses of 15 ml of the same solution once in every hour, starting 1 hour after the loading dose. patient controlled epidural analgesia (PCEA) will be programmed so that 8 ml of the same solution with a lock-time of 10 ml may be administered
Difference between total local anaesthetic consumption
The study will involve monitoring the patients starting 2 minutes after the initial epidural dose, every 2 minutes during the first 20 minutes. Monitoring will continue at the 30th minute, and once in every 90 minutes for 5 hours or until labor is completed. Total bupivacain consumption will be calculated as follows: PIEB + PCEA + boluses by the clinician. Bupivacain consumption per hour will be calculated.
Time frame: 5 hours or before if the labor is completed
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ataturk University