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Intrathecal injection of fentanyl and sufentanil along with bupivacaine in painless labor

Comparison of intrathecal injection of fentanyl and sufentanil along with bupivacaine in the onset, duration and quality of painless labor; A randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230403057808N1
Enrollment
80
Registered
2023-04-19
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Intrathecal injection of fentanyl and sufentanil in combination with bupivacaine in onset, duration and quality of painless labor. Complication of labor and delivery, unspecified

Interventions

Intervention 1: Intervention group1: In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Primiparous or multiparous pregnant mothers with term pregnancy Single fetus American Society of Anesthesiologists' (ASA) classification I, II In the advanced stage of labor with cervical dilation at least 5 centimeter in Primiparous and at least 4 centimeter in multiparous mothers Age more than 18 years Tending to have painless labor

Exclusion criteria

Exclusion criteria: Refusal to participate in the study by pregnant mothers Obesity Endocrine disease Drug abuse Allergy to study drugs Regional anesthesia contraindications such as coagulopathy, high intracranial pressure and infection of injection site .

Design outcomes

Primary

MeasureTime frame
Mean time of onset of sensory block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Pinprick response in both lower limbs.;Mean time of duration of sensory block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Pinprick response in both lower limbs.;The state of motor block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Bromage test: zero (full flexion of knees and ankles), one (ability to move only knees), two (ability to move only legs), and three (inability to move knees and feet).;Labor pain score. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Based on visual analog scale as 1-10.;Satisfaction status of pregnant mothers with the quality of analgesia. Timepoint: After transferring pregnant mothers to recovery and stabilization of vital signs. Method of measurement: Numerical Rating (NRS) based on percentage.

Secondary

MeasureTime frame
Drug complications: (Blood pressure drop more than 20% of baseline, itching, chills, nausea and vomiting, cases leading to cesarean section). Timepoint: The duration of the procedure. Method of measurement: Observance.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Ghazanfar Tehran

Rasht University of Medical Sciences

Tehranisamaneh88rasht@gmail.com+98 13 3332 9524

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026