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NCT Number: NCT04464616

Adding Different Additives to Bupivacaine-fentanyl Mixture in Spinal Anesthesia for Cesarean Section

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

About this study

Spinal anesthesia is widely used in cesarean section, but it is associated with high incidence of side effects. To reduce the occurrence of side effects, intrathecal adjuvant was recommended to use in spinal anesthesia, with the aim in reducing the dose of intrathecal local anesthetic, which can subsequently decrease the incidence of spinal-induced side effects and prolong postoperative analgesia.Many augmentation strategies for intrathecal analgesia have been proposed. A meta-analysis by Popping et al. concluded that the concomitant use of an opioid such as fentanyl intrathecally allows the reduction in the dose of local anesthetic, while augmenting its analgesic potency thereby decreasing its adverse effects.

Dexamethasone relieves pain through reducing inflammation and blocking of nociceptive C- fibers transmission and by suppressing neural ectopic discharge. Post-operative analgesic effectiveness and duration was prolonged when dexamethasone was used as an adjunct for peripheral nerve blocks. Recent studies reported no complications associated with intrathecal dexamethasone.

Dexmedetomidine (DEX) is a potent, selective α2 adrenergic agonist and when given intrathecally, it exerts its analgesic effect via stimulating spinal α2 receptors. Wu et al., in their meta-analysis showed that addition of intrathecal DEX significantly increased the duration of postoperative analgesia and reduced analgesic consumption. The increase in duration of postoperative analgesia is dose dependent but with increase in the incidence of bradycardia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 90 parturient
  • the statue of American Society of Anesthesiologists' physical class II
  • prepared for an elective cesarean section.

Exclusion criteria

  • BMI > 35kg/m2
  • gestational age < 28 weeks
  • diabetes or gestational diabetes
  • hypertension or pre-eclampsia
  • contraindications to spinal anesthesia
  • height less than 160 Cm
  • history of psychiatric disease
  • taking α-receptor antagonist drugs -a history of allergy to the study drugs-
  • excessive hemorrhage needing transfusion.

Treatment and study plan

spinal anaesthesia

Procedure

spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.

Other names: intrathecal anaesthesia

Primary outcomes

  1. time for the first request of rescue analgesia

    Time frame: postoperative first day

    time for the first request of rescue morphine analgesia at dose of 3 mg

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: postoperative first day

    Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 3 mg will be given till NRS decreases to ≤3. NRS will be assessed and recorded immediately postoperative, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.

  2. Maternal satisfaction

    Time frame: postoperative first day

    Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).

  3. Neonatal outcome

    Time frame: time of delivery of fetus

    Neonatal outcome will be assessed in terms of Apgar score.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Effect of Adding Dexmedetomidine or Dexamethasone to Bupivacaine-Fentanyl Mixture in Spinal Anesthesia for Cesarean Section

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Feb 16, 2021

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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