An interventional study of Fix protocol and medications following demand protocol in Pain Management and Cesarean Section, sponsored by HaEmek Medical Center, Israel. Completed at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-08.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Treatment
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).
The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).
The protocols will be used for the first 48 hours following surgery.
HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication): At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams). After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams. Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day. The total amount of paracetamol is limited to 4 gr per day.
Drug: Fix protocol
The same combinations will be given as in the fixed protocol however only after patient request
Drug: medications following demand protocol
Please see arm description
Please see arm description
The efficacy of pain management
Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain
Time frame: during 48 hours from surgery
adverse effect of the medications given in each protocol
Time frame: during 48 hours following surgery
to compare the amount of breastfeeding between 2 groups
Time frame: following the week after surgery
The number of times that pain medications were given in each study group
Time frame: during 48 hours following surgery
The necessity of additional medications (rescue doses)
Time frame: During 48 hours after surgery
Patient satisfaction
Each patient will fill in a satisfaction questioner which is given 48 hours after surgery
Time frame: 48 hours after surgery
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel