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Protective Analgesia in Caesarean Section Using Intravenous Paracetamol

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. Read our disclaimer for details. Identifier: NCT03060265
Recruitment Status : Unknown
Verified February 2017 by MOSTAFA.SOMRI, Bnai Zion Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
MOSTAFA.SOMRI, Bnai Zion Medical Center

Brief Summary:

Protective analgesia in caesarean section using intravenous paracetamol: A prospective randomised controlled trial. Cesarean section a common surgical procedure in women. The parturients undergoing CS experience severe to moderate postoperative pain. Pain relief is very important to the patient as it causes discomfort which affects hemodynamic intraoperative and increases the risk of postoperative complications. Analgesia is crucial to postoperative recovery.

Aims: To investigate the efficacy of combined administration of paracetamol, as protective multimodal analgesia, and standard spinal anesthesia in the reduction of postoperative pain following cesarean section.

Sixty adult Parturients undergoing CS will participate in a single-centered, randomized, double-blinded, placebo-controlled trial divided into 2 groups 30 each. The intervention group will receive 1 gr of intravenous paracetamol in 100 ml normal saline only 15 minutes prior to spinal anesthesia induction. The control group will receive 100 ml normal saline IV identical in size and shape and manner to the experimental group, 15 minutes prior to induction of spinal anesthesia. We will measure postoperative Visual Analog Scale (VAS) pain score, postoperative time to analgesia in PACU and number of postoperative analgesic doses within 24 hours.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Paracetamol Drug: PLACEBO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Protective Analgesia in Caesarean Section Using Intravenous Paracetamol: A Prospective Randomised Controlled Trial
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Paracetamol
Paracetamol Braun Germany 1 gram in 100ml normal saline, one dose IV
Drug: Paracetamol
Administrating Paracetamol IV pre-cesarean section
Other Name: Acamol

Placebo Comparator: Placebo
100ml normal saline, one dose IV
Administrating SALINE IV pre-cesarean section
Other Name: SALINE

Primary Outcome Measures :
  1. The pain intensity level [ Time Frame: 24 hours ]
    measured by VAS score The pain intensity level presented in VAS scale (0- none, 10-the worst imaginable pain) will be estimated and marked at arrival in PACU ,2, 4, 8, 12 and 24 hours postoperatively will be estimated.

Secondary Outcome Measures :
  1. side effects [ Time Frame: 24 hours ]
    Side effects such as local pain, nausea, vomiting, hypo tension, be recorded.

  2. Postoperative time to administration of first analgesic dose (Time-to-Analgesia; TTA). [ Time Frame: 24 hours ]
    measuring time in mins or hours

  3. Number of analgesic doses administered in the first 24 hours after surgery. [ Time Frame: 24 hours ]
    recording the administration of analgesic doses in number

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:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Parturient age between 18 and 40 years,
  • A maximal American Society of Anesthesiologists (ASA) Score of II,
  • Parturients undergoing first elective cesarean section.

Exclusion Criteria:

  • Current or previous chronic NSAID or opioid treatment, liver or renal insufficiency, asthma, cardiovascular disease, allergy to paracetamol or other NSAIDs.
  • Parturients with ASA III, IV and whom spinal anesthesia failure will be also excluded from the study.

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 identifier (NCT number): NCT03060265

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Contact: Mostafa Somri, Prof # 972-4-8359304

Sponsors and Collaborators
Bnai Zion Medical Center
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Principal Investigator: Mostafa Somri, Prof Bnai Zion Medical Center

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Responsible Party: MOSTAFA.SOMRI, Director of Anesthesia Department, Bnai Zion Medical Center Identifier: NCT03060265    
Other Study ID Numbers: BnaiZionMC-16-MS-003
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
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
Keywords provided by MOSTAFA.SOMRI, Bnai Zion Medical Center:
multimodal analgesia
cesarean section
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs