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CompletedNCT03767920Updated Aug 5, 2020

Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

An interventional study of bupivacaine and dexamethasone in Cesarean Section, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Cesarean Section

Keywords

  • dexamethasone
  • transversus abdominis plane block
  • cesarean section
03

In context

Lead sponsor

Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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,
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    bupivacaine and dexamethasone

    Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

    Drug: bupivacaine · Drug: dexamethasone

  • Active comparator
    bupivacaine and placebo to dexamethasone

    BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

    Drug: bupivacaine · Drug: placebo to dexamethasone

Interventions

  • Drugbupivacaine

    TAP block with 20 ml of 0.25% bupivacaine bilaterally

    Also known as: Active Comparator

  • Drugdexamethasone

    TAP block with 4 mg dexamethasone bilaterally

    Also known as: active comparator

  • Drugplacebo to dexamethasone

    TAP block with 4 mg placebo to dexamethasone bilaterally

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Visual analog score for pain during movement

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

    Time frame: 6 hours post operative

Secondary outcomes

  1. Visual analog score during rest

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

    Time frame: 48 hours postoperative

  2. number of patients need Fentanyl consumption

    number of patients need Fentanyl consumption

    Time frame: 48 hours postoperative

  3. number of days patients stay in hospital

    calculation of number of days patients stay in hospital

    Time frame: 4 weeks

07

Study locations

1 site
  • Aswan University
    Aswan, 81528, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03767920
Lead sponsor
Aswan University Hospital
Responsible party
hany farouk (Principal Investigator, Aswan University Hospital) — Principal investigator
First posted
Dec 7, 2018
Start date
Jan 1, 2019
Primary completion
Mar 30, 2020
Completion
Aug 1, 2020
Last update
Aug 5, 2020

Study contacts

hany f sallam, md
principal investigator · Aswan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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