Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02504749 |
| Other study ID # |
KasrELAini |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
July 18, 2015 |
| Last updated |
January 29, 2016 |
| Start date |
July 2015 |
| Est. completion date |
June 2016 |
Study information
| Verified date |
July 2015 |
| Source |
Kasr El Aini Hospital |
| Contact |
Mohamed Ab El Sharkawy, M.D. |
| Phone |
00201221731328 |
| Email |
kingdoc82[@]outlook.com |
| Is FDA regulated |
No |
| Health authority |
Egypt: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to compare the time to regain intestinal motility after general anesthesia
versus spinal anesthesia for cesarean section.
A double blinded randomized controlled trial was conducted at the Department of Obstetrics
and Gynecology, Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University,
Cairo, Egypt, between July 20 and November 20, 2015. In the study hospital, the total number
of deliveries in 2012 was 15 167, 6244 (41.2%) of which were by cesarean; in 2013, the total
number of deliveries was 16 057, 5200 (32.4%) of which were by cesarean.
Description:
The The study protocol was approved by the Scientific Research Committee of the department.
Pregnant women with indication for caesarean section were enrolled after providing informed
consent. It included 450 patients who had caesarean section and were subdivided into two
groups according to a randomization scale.On the day of the operation,each randomly received
a closed opaque envelope for the selection of the procedure(spinal versus general).
Patients were classified into two groups:
Group A: General anaesthesia group Group B:Spinal anaesthesia group.
All patients are subjected to the following:
1. Patients admitted from the outpatient clinic at Kasr El Ainy university Maternity
Hospital.
2. Explanation of the procedure to all women participating in the study.
3. Informed written consent from every woman participating in this study.
4. Full history taking:
- Full name,age,telephone number and address.
- Past medical history of hypertension,diabetes and other endocrine diseases,also
history of abdominal operations.
- Gravidity and parity.
5. Examination:
1-Vital signs(pulse,blood pressure,temperature and respiratory rate). 2-Measurement of
weight in kilograms,height in meters and calculation of body mass index.
6-Full laboratory investigations especially Complete blood count,liver functions,kidney
functions,coagulation profile and random blood sugar.
7-Ultrasound assessment of fetal well being.
8-All women fasting for at least 8 hours prior to surgery.
General anaesthesia steps:
-Standard rapid sequence induction with pre-oxygenation by 100 % OXYGEN FOR 3 MINUTES
FOLLOWED BY 4-5 mg/kg thiopental and 100 mg succinylcholine,cricoid pressure was applied
once necessary.After correct placement of tracheal tube was confirmed,anaesthesia was
maintained with up to 1.5% isoflurane and oxygen,neuromuscular blockade was maintained with
0.4 mg/kg atracurium.
Spinal anaesthesia steps:
Prehydration with 500 ml lactated ringer solution intravenous within 15 minutes in the
sitting position.Low back was prepared and drapped in a sterile fashion with Betadine
solution 10%.
Spinal anaesthesia performed at L 2-3 or L 3-4 intervertebral space using a fine needle size
22 G.Injection of local anaesthetics into the subarachnoid space,Bupivacaine(marcaine) 1.5
-3.5 ml used.
Operative data:
- Caesarean section done by senior resident.
- Skin opened by pfannensteil incision
- The abdomen opened in layers.
- The peritoneum opened by elevating it with two clamps placed 2 cm apart. It is incised
sharply superiorly to the upper pole of the incision and downward to just above bladder
reflection.
- The lower peritoneal flap elevated and gentle blunt bladder dissection done.
- Transverse incision of the lower uterine segment.
- The baby is delivered:a hand is slipped into the uterine cavity between the symphysis
and fetal head.Head elevation with the fingers and palm through the incision.
- Intravenous infusion containing 20 units of oxytocin after shoulder delivery.
- Spontaneous placental delivery.
- Closure of uterine incision in two layers using blunt needle and absorbable continuous
Vicryl 1 sutures (Ethicon; Somerville,New Jersey,, USA) in a continuous double layer.
- Closure of visceral and parietal peritoneum by continuous absorbable suture Vicryl 2-0.
- Rectus sheath sutured using continuous absorbable suture Vicryl 1 sutures.
- In all patients, the fascia was closed with continuous Vicryl 1 sutures, subcutaneous
fat was closed with interrupted Vicryl 2-0 sutures, and the skin was closed with
subcuticular Prolene 2-0 sutures (Ethicon).
The data were recorded including presence of adhesions,application of intraperitoneal
towels,estimated blood loss,operative time,time from start of caesarean section to fetal
extraction and closure events.
After the end of surgery:
- close observation for vital data,vaginal bleeding and urine output.
- The same hospital fluid regimen with 500 ml of 5 % glucose every 6 hours,500 ml of
ringer every 12 hours and 500 ml saline every 24 hours.
- Postoperatively, all patients were given 75 mg diclofenac sodium (Voltaren;
Novartis,Cairo, Egypt) as intravenous infusion in dextrose, followed by 50 mg
diclofenac potassium (Cataflam; Novartis) orally every 8 hours for pain relief.
- No oral or rectal bowel stimulants were given after surgery.
- Auscultation of intestinal sounds started two hours after operation and was performed
at one hour interval till normal bowel sounds were detected.
- The patients allowed to sip small amount of water only 12 hours postoperatively.
- The oral intake of clear fluid and soft food was allowed when normal bowel sounds were
detected and flatus has passed with advancement to regular diet after passage of first
bowel motion.
- Clinically significant ileus was considered with appearance of group of
manifestations(persisting more than 24 hours or requiring nasogastric tube placement)
which include absent or hypo active bowel sounds,abdominal distension and more than
three episodes of vomiting with or without crampy abdominal pain.
- Eligible criteria for hospital discharge included:stable vital signs with no febrile
morbidity for at least 24 hours,ability to ambulate and to urinate without
assistance,passage of bowel motion,ability to tolerate solid food without emesis and
absence of unresolved other postoperative complications.
The main outcome measures are:
- Case number
- Age
- Parity
- Gestational age
- Body mass index.
- Duration of surgery.
- Time of 1 st intestinal sound
- Time of 1 st flatus.
- Time of 1 st motion
- Duration of hospital stay.
- Post operative fever,distension or ileus.
- Opioid and Non steroidal anti-inflammatory use.
