Clinical trial NCT03815877: The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section.
Official title: The Effect of Caffeine Ingestion in Prevention of Postoperative Ileus After Caesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Cesarean Section Complications
Caffeine
Keywords: Caffeine
Postoperative Ileus
Caesarean Section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Many trials have been made to prevent paralytic ileus , including administration of prokinetic drugs , early resumption of feeding, gum chewing and adequate pain control. Unfortunately, none of these strategies has been completely successful. Recently the effect of caffeine on prevention of postoperative ileus after caesarian section was researched. That's why this study is designed to determine the efficacy of caffeine in prevention of postoperative ileus after caesarean section.

Detailed description: -Study design: This study will include 600 women undergoing their caesarean section. The study aims will be explained to all women and an informed written consent will be taken. All recruited women will be distributed into two groups according to a computerized randomization table. The researcher consecutively will open sequentially numbered, opaque, sealed envelopes containing cards with letters either letter (C) or letter (N), Cards with letter (C) will represent the group who will receive the caffeinated coffee and cards with letter (N) will represent the group who will receive the decaffeinated coffee

Procedure:

* For all women, the anesthetic used will be Marcaine® Spinal heavy 0.5% and fentanyl and for post-operative pain, ketorolac will be used.
* Through Pfannenstiel incision, transverse lower segment uterine incision is done, with the duration of the surgery not exceeding 90 minutes
* women will not be permitted to drink or eat, except for the drink offered by the researcher, till passing flatus. Early ambulation will be encouraged.
* A stethoscope will be used to detect the first intestinal movement each hour after the surgery. The women will be advised to notify the researcher when they pass both flatus and feces.

Intervention:

* The intervention plan will be performed within the first 24 hours after the surgery.
* Provided by the researcher within 10 minutes, patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery, and the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at the same intervals.
* No other liquid will be allowed till passage of flatus and feces in the first day of surgery.
* Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group. Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group.
* Statistical Package:
* Data analysis will be performed by Statistical Package for the Social Science (SPSS) 16.0 using descriptive statistics tools, including mean, standard deviation and figures. A t-test will be used to compare mean values of the two groups. P-values, smaller than 0.05, were considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* women undergoing caesarean section
* Spinal anaesthesia
* Total surgery time less than 90 minutes

Exclusion Criteria:

* Previous complicated abdominal surgery or caesarean section with extensive adhesions requiring extensive dissection or intestinal manipulation.
* Caesarean section complicated by postpartum hemorrhage or in the women who received misoprostol.
* Intraoperative intestinal complications.
* Intraoperative respiratory complication.
* Chronic intestinal diseases: irritable or inflammatory bowel diseases.
* Chronic diarrhea or constipation.
* Using laxatives pre-operatively.
* Known hypersensitivity to caffeine
* Thyroid or hepatic disease.
* Cardiac arrhythmias

Primary outcomes:
measure: A change in the number of hours for women to pass flatus for the first time after an elective caesarean section
timeFrame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass flatus.
Secondary outcomes:
measure: A change in the number of hours for the women to have their first intestinal sound to be heard by a stethoscope after caesarean section
timeFrame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. A stethoscope will be used to detect the first intestinal movement every hour after the surgery
measure: A difference in the number of hours for the women to pass stool after caesarean section.
timeFrame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher when they pass feces.
measure: A difference in the number of the women's hospital stay hours after caesarean section
timeFrame: calculating the number of the women's hospital stay hours after caesarean section up to 12 weeks
measure: Occurrence of postoperative spinal headache
timeFrame: patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery. The women will be advised to notify the researcher with the occurrence, severity and relief of spinal headache during the hospital stay.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: AMR NADIM
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: REDA GHANEM
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: MADONNA BENYAMINE
role: PRINCIPAL_INVESTIGATOR
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