Protective Analgesia in Caesarean Section Using Intravenous Paracetamol
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|ClinicalTrials.gov Identifier: NCT03060265|
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: Paracetamol
Paracetamol Braun Germany 1 gram in 100ml normal saline, one dose IV
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
- 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.
- side effects [ Time Frame: 24 hours ]Side effects such as local pain, nausea, vomiting, hypo tension, be recorded.
- Postoperative time to administration of first analgesic dose (Time-to-Analgesia; TTA). [ Time Frame: 24 hours ]measuring time in mins or hours
- Number of analgesic doses administered in the first 24 hours after surgery. [ Time Frame: 24 hours ]recording the administration of analgesic doses in number
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): NCT03060265
|Contact: Mostafa Somri, Prof||# email@example.com|
|Principal Investigator:||Mostafa Somri, Prof||Bnai Zion Medical Center|