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Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Not Applicable
Completed
Conditions
Cesarean Section
Interventions
Registration Number
NCT03767920
Lead Sponsor
Aswan University Hospital
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
120
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,

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
bupivacaine and placebo to dexamethasoneplacebo to dexamethasoneBilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
bupivacaine and placebo to dexamethasonebupivacaineBilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
bupivacaine and dexamethasonebupivacaineBilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
bupivacaine and dexamethasonedexamethasoneBilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
Primary Outcome Measures
NameTimeMethod
Visual analog score for pain during movement6 hours post operative

movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

Secondary Outcome Measures
NameTimeMethod
number of patients need Fentanyl consumption48 hours postoperative

number of patients need Fentanyl consumption

number of days patients stay in hospital4 weeks

calculation of number of days patients stay in hospital

Visual analog score during rest48 hours postoperative

ranging from 0 to 10, where 0 no pain and 10 maximum pain

Trial Locations

Locations (1)

Aswan University

🇪🇬

Aswan, Egypt

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