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Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

A

Aswan University Hospital

Status

Completed

Conditions

Cesarean Section

Treatments

Drug: dexamethasone
Drug: placebo to dexamethasone
Drug: bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03767920
aswu/180/7/18

Details and patient eligibility

About

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 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.

Enrollment

120 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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