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Comparing Protocols for Analgesia Following Elective Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622489
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center

Brief Summary:

Women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia:

  1. Scheduled doses of IV acetaminophen + PO Ibuprofen
  2. Scheduled doses of PO acetaminophen + PO Ibuprofen
  3. "On demand" doses of acetaminophen, dipyrone and ibuprofen.

Condition or disease Intervention/treatment Phase
Postoperative Pain Post-Cesarean Section Drug: Acetaminophen Drug: Ibuprofen 400 mg Drug: Dipyrone Drug: Tramadol Drug: Morphine Drug: Tramal Phase 4

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:

  1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Protocols for Analgesia Following Elective Cesarean Section
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tab ibuprofen + IV acetaminophen

All women will receive immediately after surgery, in the recovery room:

  1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
  2. 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
mentioned above

Drug: Ibuprofen 400 mg
mentioned above

Drug: Tramadol
mentioned above
Other Name: Tramadex

Drug: Morphine
mentioned above

Drug: Tramal
mentioned above

Experimental: Tab Ibuprofen + Tab acetaminophen

All women will receive immediately after surgery, in the recovery room:

  1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
  2. 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
mentioned above

Drug: Ibuprofen 400 mg
mentioned above

Drug: Tramadol
mentioned above
Other Name: Tramadex

Drug: Morphine
mentioned above

Drug: Tramal
mentioned above

Experimental: "On demand" analgesia

All women will receive immediately after surgery, in the recovery room:

  1. IV morphin 5 mg, repeat doses every 10 minutes for VNS>3
  2. 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
mentioned above

Drug: Ibuprofen 400 mg
mentioned above

Drug: Dipyrone
mentioned above

Drug: Tramadol
mentioned above
Other Name: Tramadex

Drug: Morphine
mentioned above

Drug: Tramal
mentioned above




Primary Outcome Measures :
  1. Average pain score 48 hours following surgery: visual numerical scale (VNS) [ Time Frame: 48 hours ]
    Using : visual numerical scale (VNS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622489


Contacts
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Contact: Lotem Dafna, MD +972524205415 lotemdafne@yahoo.com

Locations
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Israel
Wolfson medical center Recruiting
Holon, Israel
Contact: Rinat Hirsh    +97235028346    rinath@wmc.org.il   
Principal Investigator: Lotem Dafna, MD         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
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Study Chair: Michal Kovo, MD Wolfson Medical Center

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Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT03622489    
Other Study ID Numbers: 0022-17-WOMC
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Dipyrone
Ibuprofen
Morphine
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action