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NCT Number: NCT05342844

Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery

Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.

Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University-Emergency hospital-ICU

Al Mansurah, 35511, Egypt

About this study

This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 19 to 40 years old
  • American Society of Anesthesiologists (ASA) physical status II patients
  • Singleton pregnancies with a gestational age of at least 37 weeks.
  • Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.

Exclusion criteria

  • Age < 19 or > 40 years.
  • Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
  • Inability to comprehend or participate in the pain scoring system.
  • Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
  • Hypersensitivity to any drug used in the study.
  • Any hypertensive disorders of pregnancy.
  • Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
  • Significant cardiovascular, renal or hepatic abnormalities.
  • Patients with history of opioid intake, drug abusers or psychiatric patients

Treatment and study plan

Dexmedetomidine 0.5 mcg

Drug

0.5 mcg/kg

Dexmedetomidine 1 mcg

Drug

1 mcg/kg

Primary outcomes

  1. The time of the first postoperative analgesic requirement

    Time frame: during the first 24 postoperative hours

Secondary outcomes

  1. Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the

    Time frame: during the first 24 postoperative hours

    mg

  2. The visual analog scale (VAS) scores during rest

    Time frame: during the first 24 postoperative hours

    11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively

  3. The visual analog scale (VAS) scores during movement

    Time frame: during the first 24 postoperative hours

    11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively

  4. Mean arterial blood pressure (MBP)

    Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

    mmHg

  5. heart rate (HR)

    Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

    beat per minute

  6. Patient satisfaction about the quality of postoperative analgesia

    Time frame: during the first 24 postoperative hours

    poor = 1, fair = 2, good = 3, excellent = 4

  7. The side effects (nausea, vomiting, abdominal colic and lower limb weakness)

    Time frame: during the first 24 postoperative hours

    incidence

  8. the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome

    Time frame: during the first 24 postoperative hours

  9. The level of sedation

    Time frame: during the first 24 postoperative hours

    using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery

Acronym: TAP_dexmedet

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Jun 23, 2023

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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