Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Overview

Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section. – Group 1: bupivacaine 0.25% + dexamethasone 8 mg – Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.

Full Title of Study: “Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2020

Detailed Description

The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects . Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.

Interventions

  • Drug: bupivacaine
    • TAP block with 20 ml of 0.25% bupivacaine bilaterally
  • Drug: dexamethasone
    • TAP block with 4 mg dexamethasone bilaterally
  • Drug: placebo to dexamethasone
    • TAP block with 4 mg placebo to dexamethasone bilaterally

Arms, Groups and Cohorts

  • Active Comparator: bupivacaine and dexamethasone
    • Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
  • Active Comparator: bupivacaine and placebo to dexamethasone
    • BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

Clinical Trial Outcome Measures

Primary Measures

  • Visual analog score for pain during movement
    • Time Frame: 6 hours post operative
    • movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary Measures

  • Visual analog score during rest
    • Time Frame: 48 hours postoperative
    • ranging from 0 to 10, where 0 no pain and 10 maximum pain
  • number of patients need Fentanyl consumption
    • Time Frame: 48 hours postoperative
    • number of patients need Fentanyl consumption
  • number of days patients stay in hospital
    • Time Frame: 4 weeks
    • calculation of number of days patients stay in hospital

Participating in This Clinical Trial

Inclusion Criteria

  • healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia Exclusion Criteria:

  • Participants had known sensitivity to bupivacaine – patient refusal, – localized infection over injection point – patients with significant coagulopathies and – with contraindications to regional anesthesia, – patients with heart diseases, altered renal or liver functions, – psychological disorders, patients with pregnancy-induced hypertension and – gestational diabetes, chronic use of pain medications,

Gender Eligibility: Female

healthy parturient scheduled to undergo LSCS under spinal anesthesia

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aswan University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: hany farouk, Principal Investigator – Aswan University Hospital
  • Overall Official(s)
    • hany f sallam, md, Principal Investigator, Aswan University Hospital

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