Protective Analgesia in Caesarean Section Using Intravenous Paracetamol

NCT03060265 | Unknown DMC

• 1 other identifier: BnaiZionMC-16-MS-003
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesia

Keywords

multimodal analgesia; paracetamol; cesarean section

Outcome Measures

Primary Outcomes (1)

• The pain intensity level

  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.

  24 hours

Secondary Outcomes (3)

• side effects

  24 hours

• Postoperative time to administration of first analgesic dose (Time-to-Analgesia; TTA).

  24 hours

• Number of analgesic doses administered in the first 24 hours after surgery.

  24 hours

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Paracetamol Braun Germany 1 gram in 100ml normal saline, one dose IV

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

100ml normal saline, one dose IV

Drug: PLACEBO

Interventions

Paracetamol DRUG

Administrating Paracetamol IV pre-cesarean section

Also known as: Acamol

Paracetamol

PLACEBO DRUG

Administrating SALINE IV pre-cesarean section

Also known as: SALINE

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mostafa Somri, Prof

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Somri, Prof

CONTACT

# 972-4-8359304; mostafa.somri@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesia Department

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share