Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05535036 |
| Other study ID # |
dexa C section |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2020 |
| Est. completion date |
January 4, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
Mongi Slim Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The management of postpartum pain is essential to ensure early rehabilitation for
parturients. Intravenous dexamethasone has a potent analgesic action when used in the context
of general anesthesia. Nevertheless, it remains poorly studied in combination with spinal
anesthesia (SA). The aim of this study was to assess the analgesic effect of intravenous
dexamethasone after caesarean section under SA.
Methods: We conducted a prospective, randomized, double-blinded study including 84 ASA II-III
parturient at term who were proposed for caesarean section under SA. Parturient were
randomized into two groups: Dexamethasone group (DG) who received 8mg of intravenous
dexamethasone (2ml) immediately after SA and placebo group (PG) who received 2ml of isotonic
saline. The analgesic protocol was standardized and we opted for Tramadol as rescue
analgesic. The main outcome is the use of Tramadol in the first 24 hours postpartum..
Description:
A a prospective randomized double-blinded controlled study including 84 parturient women,
conducted at the Anesthesia and Surgical Intensive Care Department of Mongi Slim University
Hospital, La Marsa Tunisia. It was performed after obtaining the approval of the Research
Ethical Committee of our hospital (Ethical Committee No. 02/2020). Eligible patients were
informed of the study design and their written consent was obtained.
Patients:
Inclusion criteria were Age >= 18 years, American Society of Anesthesiologists (ASA) statue
II-III, a pregnancy term >= 37 weeks, elective cesarean section and Pfannenstiel incision.
Exclusion criteria were severe hypertension / preeclampsia, poorly balanced diabetes
mellitus, allergy to one of the study drugs, patients with chronic pain or long-term use of
opioids, and patients on long-term corticosteroid therapy.
Study protocol During the preoperative visit, all patients have had a full clinical
examination and further examinations have been requested in accordance with the most recent
guidelines. The informed written consent was obtained at this moment. Postoperative pain
predisposition (the prediction of pain and the anxiety level) was assessed using a
questionnaire.
Randomization and allocation were performed using a computer-generated sequence of
randomization numbers and the envelope technique; patients were randomized into two groups:
- Dexamethasone Group (DG): receiving 8mg (2ml) of intravenous (IV) Dexamethasone after
spinal anesthesia
- Placebo Group (PG): receiving 2 ml of IV Saline solution after spinal anesthesia.
Patients enrolled and the anesthesiologists in charge were both blinded to the study group.
In the operating room, all patients had standard non-invasive monitoring including an
electrocardiogram, non invasive blood pressure and pulse oxymetry. An 18-gauge intravenous
cannula was inserted into the nondominant arm or hand and 500 ml of a saline solution (0.9 %)
was infused. The prevention of postoperative nausea and vomiting (PONV) was assured to all
patients by administering 4 mg of IV Ondansetron. Spinal anesthesia was performed according
to our department protocol: L4-L5 or L3-L4 intervertebral space puncture using a 25 gauges
needle, with injection of 0.5% hyperbaric Bupivacaine mixture (dose depending on patient
height) associated with 2.5 ug Sufentanil and 100 ug Morphine. Before surgical incision,
patients received either an intravenous injection of 8 mg (2 ml) Dexamethasone (DG) or 2 ml
of a Saline solution (PG). During the procedure, we noted hemodynamic constants, surgical
related data and APGAR score for the newborns. At the end, patients were transferred
initially to the post-operative monitoring room, and then to the Gynecology Obstetric
department after assessing the hemodynamic constants, the absence of bleeding, the good tone
of the uterine globe and the disappearance of the motor block.
The analgesic protocol was standardized: systemic analgesia during the first 24 hours was
assured by a postoperative regimen combining intravenous Paracetamol 1g*4/day and Nefopam 20
mg*3/day . The rescue analgesic is IV Tramadol 100 mg administered at the request of the
patient and if the analog visual scale (AVS) was greater than 3/10, with a maximum dose of
100 mg * 3/day. Static and dynamic pain was assessed at 2 hours, 6 hours, 12 hours and 24
hours postoperatively using the analog visual scale ( values raging from 0 for no pain to 10
for a maximum pain). Time to first request and cumulative dose of Tramadol were recorded. We
also noted the length of the sensory and the motor blocks, postoperative nausea and vomiting
and patient satisfaction. Hospital discharge was allowed after 24 hours if there were no
complications.
Follow-up at 3 months:
Patients were contacted after 3 months to complete a telephonic survey about chronic pain and
postpartum depression . We excluded patients who had other surgery within 3 months of the
cesarean section or any other cause of chronic pain.
Outcomes:
Our main outcome was the use of Tramadol within the first 24 hours. Secondary endpoints were
static and dynamic analog visual scale at 2 hours, 6 hours,12 hours, and 24 hours, time to
first request of Tramadol, cumulative Tramadol dose within the first 24 hours, length of
sensory and motor block, incidence of post-operative nausea and vomiting (PONV), chronic pain
at 3 months, incidence of postpartum depression, and patient satisfaction.
