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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464616
• Other study ID #: spinal additives in CS
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: July 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 20, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 a-receptor antagonist drugs -a history of allergy to the study drugs-

• excessive hemorrhage needing transfusion.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• spinal anaesthesia
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.

Locations

Country	Name	City	State
Egypt	Tarek Abdel Hay	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for the first request of rescue analgesia	time for the first request of rescue morphine analgesia at dose of 3 mg	postoperative first day
Secondary	Numerical Rating Scale	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.	postoperative first day
Secondary	Maternal satisfaction	Maternal satisfaction will be evaluated on a 0-3 score (0 = poor, 1 = fair, 2 = good, and 3 = excellent).	postoperative first day
Secondary	Neonatal outcome	Neonatal outcome will be assessed in terms of Apgar score.	time of delivery of fetus