Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

Postoperative Pain Clinical Trial

Official title:

Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018301
• Other study ID #: IRB0000871238
• Status: Recruiting
• Phase: Phase 2
• First received: January 10, 2017
• Last updated: January 10, 2017
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: Abdelrady S Ibrahim, MD
• Phone: 00201026249924
• Email: aradys2004[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.

Description:

• No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.

• 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.

• All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.

• After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.

• Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to ＜ 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.

• Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Eligible women ASA class 1 and 2, are at term (=37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.

Exclusion Criteria:

• • Body mass index =40 kg/m2,

• Known allergy to any of the study medications,

• Contraindication to the spinal anesthesia,

• History of substance abuse,

• History of hallucinations,

• Chronic opioid therapy,

• Chronic pain.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.

Other:
• Normal saline
will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Number of Subjects Requiring Supplemental Analgesia		24 hours postoperative	Yes
Secondary	Cumulative morphine/paracetamol		24 hours postoperative	Yes
Secondary	Number of subjects reporting nausea, vomiting		24 hours postoperative	Yes