Comparing Protocols for Analgesia Following Elective Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia: Scheduled doses of IV acetaminophen + PO Ibuprofen Scheduled doses of PO acetaminophen + PO Ibuprofen On demand doses of acetaminophen, dipyrone and ibuprofen.

Detailed Description
-----------------
A prospective randomised trial. Women undergoing elective cesarean section will be randomized to three groups. The treatment will be given for 48 hours after surgery. For evealuating objective pain sensation the investigators will be using the Visual Numerical Score (VNS). Demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores. Exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs. Number of participants: 120 Treatment: All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 IV Tramal 100 mg, once After Admitted to Mternity ward: 1st group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr 2nd group will be receiving scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr 1st+2nd group will be given additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. - 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score: Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses. PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses. Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses.

Official Title
-----------------
Comparing Protocols for Analgesia Following Elective Cesarean Section

Conditions
-----------------
Postoperative Pain, Post-Cesarean Section

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Ibuprofen 400 mg
* Drug: Dipyrone
* Drug: Tramadol
* Drug: Morphine
* Drug: Tramal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing elective cesarian section Exclusion Criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tab ibuprofen + IV acetaminophen<br>All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 IV Tramal 100 mg, once After Admitted to Maternity ward: - Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and IV Acetaminophen 1 gr 14:00 hr, IV Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, IV Acetaminophen 1 gr -Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. | Drug: Acetaminophen<br>* mentioned above<br>Drug: Ibuprofen 400 mg<br>* mentioned above<br>Drug: Tramadol<br>* mentioned above<br>* Other names: Tramadex;Drug: Morphine<br>* mentioned above<br>Drug: Tramal<br>* mentioned above<br>|
| Experimental: Tab Ibuprofen + Tab acetaminophen<br>All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 IV Tramal 100 mg, once After Admitted to Maternity ward: - Scheduled doses: 08:00 hr, Tab. Ibuprofen 400 mg, and PO Acetaminophen 1 gr 14:00 hr, PO Acetaminophen 1 gr 19:00 hr, Tab. Ibuprofen 400 mg 00:00 hr, PO Acetaminophen 1 gr - Additional analgesia if needed according to VNS scale: PO drops Dipyrone 1 gr, for VNS>4, up to 4 times a day, at least 6 hours between doses. Tab Tramadex 100 mg, for VNS>6, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 4 hours between doses. | Drug: Acetaminophen<br>* mentioned above<br>Drug: Ibuprofen 400 mg<br>* mentioned above<br>Drug: Tramadol<br>* mentioned above<br>* Other names: Tramadex;Drug: Morphine<br>* mentioned above<br>Drug: Tramal<br>* mentioned above<br>|
| Experimental: On demand analgesia<br>All women will receive immediately after surgery, in the recovery room: IV morphin 5 mg, repeat doses every 10 minutes for VNS>3 IV Tramal 100 mg, once After Admitted to Mternity ward: Will not receive scheduled pain medication, but offered some only upon patients' request according to VNS score: Tab. Acetaminophen 1 gr, for VNS 1-3, up to 4 times a day, at east 6 hours between doses. PO drops Dipyrone 1 gr, for VNS 4-7, or if pain persists for 1 hour after receiving Acetaminophen, up to 4 times a day, at least 6 hours between doses. Tab Ibuprofen 400 mg, for VNS 8-10, or if pain persists for 1 hour after receiving Dipyrone, up to 3 times a day, at least 8 hours between doses. | Drug: Acetaminophen<br>* mentioned above<br>Drug: Ibuprofen 400 mg<br>* mentioned above<br>Drug: Dipyrone<br>* mentioned above<br>Drug: Tramadol<br>* mentioned above<br>* Other names: Tramadex;Drug: Morphine<br>* mentioned above<br>Drug: Tramal<br>* mentioned above<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain score 48 hours following surgery: visual numerical scale (VNS) | Using : visual numerical scale (VNS) | 48 hours |