Clinical trial NCT03767920: Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section
Official title: Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: dexamethasone
transversus abdominis plane block
cesarean section
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Randomized Interventional double-blind study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Visual analog score for pain during movement
timeFrame: 6 hours post operative
Secondary outcomes:
measure: Visual analog score during rest
timeFrame: 48 hours postoperative
measure: number of patients need Fentanyl consumption
timeFrame: 48 hours postoperative
measure: number of days patients stay in hospital
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: