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Completed

NCT Number: NCT06820203

Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section

This study aims to distinguish between premixed, sequential, and manually mixed administration of intrathecal fentanyl and bupivacaine in cesarean section.

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Key information

Conditions

Premixed Bupivacaine Cesarean Section Fentanyl Intrathecal Manually Mixed Sequential

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Cesarean section (CS) is a lifesaving procedure when there is both maternal and fetal problems. The rate of CS increases dramatically from time to time. Regional anesthesia techniques are highly preferred for CS compared to general anesthesia.

Coadministration of intrathecal opioids and local anesthetics (LAs) have been found to produce a potent intra and postoperative analgesic synergism without further depression of efferent sympathetic activity, hence results in less adverse hemodynamic effects, even with sub-therapeutic doses of LAs.

Fentanyl has been considered the intrathecal LAs adjuvant of choice owing to its potency, fast onset and short duration of action, and lower incidence of respiratory depression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 40 years.
  • Height between 150 to175 cm.
  • Body mass index (BMI) between 18.5 and 30 kg/m2.
  • American Society of Anesthesiology (ASA) physical status II.
  • Scheduled for cesarean section under spinal anesthesia.

Exclusion criteria

  • Pre-operation hypotension and bradycardia.
  • Preeclampsia.
  • Multiple pregnancy and macrosomia.
  • Complete or partial failed spinal.
  • Patients with skin infections at the site of injection.
  • Patients with coagulation disorders.
  • Patients with spinal deformities.
  • Patients having regional nerve block other than spinal anesthesia.

Treatment and study plan

Fentanyl and Bupivacaine

Drug

Patients will receive premixed intrathecal fentanyl and bupivacaine in the same syringe.

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of pethidine administrated).

Secondary outcomes

  1. Total analgesic consumption

    Time frame: 24 hours postoperatively

    The total amount of analgesic the patient will be given within 24 h after spinal anesthesia

  2. Degree of pain

    Time frame: 24 hours postoperatively

    The degree of pain will be assessed using the numerical rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 2, 4, 6, 8, 12, 18, and 24h postoperatively.

  3. Onset of motor block

    Time frame: Intraoperatively

    onset of motor block (defined as the time from giving spinal anesthesia until a modified Bromage score of 3 was reached). The modified Bromage scale [0: No motor block, 1: Unable to raise an extended leg (able to flex the knee), 2: Unable to flex the knee (able to move the foot only), 3: Unable to flex the ankle (unable to move the foot or knee)]

  4. Duration of motor block

    Time frame: Intraoperatively

    Duration of motor block (defined as the time from the onset of motor blockade until complete recovery, indicated by a Bromage score of 0) will be recorded

  5. Onset of sensory block

    Time frame: Intraoperatively

    Onset of sensory block (time elapsed from the end of spinal injection to absence of pinprick sensation at T10 dermatome).

  6. Duration of sensory block

    Time frame: Intraoperatively

    Duration of sensory block (The time till achieving T10 sensory level in addition to the maximum block height) will be noted and recorded.

  7. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as bradycardia, hypotension, nausea, Pruritus, shivering, respiratory depression, or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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