Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03806673 |
| Other study ID # |
Ain Shams Un |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 5, 2018 |
| Est. completion date |
September 11, 2018 |
Study information
| Verified date |
January 2019 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
epidural block is today the most common method of pain relief during labor. With increased
use of epidural analgesia, many women are found in the second or third pregnancy and require
repeated epidural analgesia. But there was a higher incidence of unilateral blockade among
women receiving their repeated epidural which causes patient unsatisfaction.
Objectives: Examination of the performance and outcome of women receiving their first versus
repeated epidural block.
Patients and methods: The study included 140 American Society of Anesthesiologists (ASA)
Physical Status II patients (age range 20 to 40 years) and scheduled for normal vaginal
delivery. The patients were divided randomly into two equal groups. Group (A) in which 70
women primipara subjected to their first epidural block while group (B) in which 70 women
multipara subjected to their repeated epidural block. For each patient, the following data
were collected: demographic data, details of labor (gestation, cervical dilatation), visual
analogue scale (VAS) before the epidural and 30 minutes after injection of local anesthetic
and incidence of unilateral block.
Description:
This study was performed after obtaining approval from the ethical committee of the Ain Shams
University. Sample of 140 healthy ASA II female patients, 20-40 years of age, scheduled for
normal vaginal delivery. Patients were randomly allocated by computer-generated random number
list into two study groups of 70 patients each.
Group (A) in which 70 primipara women subjected to their first epidural block while group (B)
in which 70 multipara women subjected to their repeated epidural block. The study was carried
out between January 2018 and March 2018.
Patients were excluded for:
- Any physical reason for difficult epidural performance e.g.: morbid obesity, or
scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
- Or withdrawal of consent. All patients in this study were subjected to a detailed
pre-anesthetic evaluation. All basic investigations according to the hospital protocol
(e.g. serum hemoglobin, platelet count, coagulation profile) were checked.
The patient's demographic data, details of labor (gestation, cervical dilatation), details of
epidural insertion were recorded by the anesthetist performing the epidural.
The patient was asked to mark a visual analogue scale (VAS) (figure 1) before the epidural
and 30 minutes after injection of local anesthetic. Also incidence of unilateral epidural
block is reported 30 minutes after injection of local anesthetic.
Figure (1): Visual analog scale 2.2 Anesthetic technique On arrival to operation room; 18 g
cannula was inserted then 500 ml of Ringer solution was infused while performing the
epidural.
Basic monitors including automatic blood pressure measurements, five lead ECG monitor, and
finger pulse oximetry were applied to all patients.
A standard procedure was followed for epidural insertion and establishment of block. With the
patient in the sitting position the midline approach was used using 16-g Tuohy needle and the
epidural space was identified by loss of resistance to air, as is our routine practice.
Once the epidural space was reached, Bupivacaine 0.25% plain, was given in three 5 ml
increments at five-minute intervals, the first administered through the needle while the
patient is in sitting position, and then through the catheter with the patient in supine
position.
Multi-orifice catheters were inserted and fixed to a standard 4 cm extra to the distance
between the skin and epidural space. At the time of insertion of the catheter the patient was
asked to report any pain or tingling experienced.
The operator recorded the ease of insertion of the catheter (difficult or easy) and the
occurrence of blood in needle or catheter. Epidurals were performed by the same anesthetists.
At 30 min after injection of bupivacaine, the second VAS was completed and the level of
blockade checked by cold sensation test. If an inadequate level was noted (less than T10),
the pain score remained high or increased, or the patient complained of poor pain relief she
was asked to describe the site and type of pain experienced.
A unilateral block was defined as the description by the patient of worse pain on one side
than the other, or pain on one side only, combined with either a 30-min pain score minimally
changed or increased from time zero or a low level of blockade on the painful side, or both.
If unilateral or inadequate block occurred the catheter was withdrawn 0.5-1 cm and a further
5 ml bupivacaine 0.25% was administered with the patient lying on the unblocked side. If the
block was still inadequate, epidural fentanyl 50 microgram was given and if still inadequate
the catheter was removed and a second epidural catheter inserted in another interspace.
The number of repeat injections of bupivacaine and length of time between epidural insertion
and delivery were noted, as well details of previous epidurals in the multiparous women.
Sample size estimation:
To show a difference in the incidence of unilateral block between the two groups with p-value
< 0.05 and power 80%, we needed at least 60 patients per group.
Statistical analysis:
Analysis of data was done by IBM computer using SPSS (statistical program for social science,
version 16) as follows:
- Description of quantitative variables as mean ± SD.
- Description of quantitative variables as number and percentage. Statistical analysis was
performed using statistical tests included Student's t-test, Chi square test and table
analysis. P value <0.05 is considered significant.
