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Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Ketamine

Normal saline

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Assiut university faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine group

Control group

Arm Description

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

will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

Outcomes

Primary Outcome Measures

• Number of Subjects Requiring Supplemental Analgesia

Secondary Outcome Measures

Cumulative morphine/paracetamol

Number of subjects reporting nausea, vomiting

Full Information

NCT ID

NCT03018301

First Posted

January 10, 2017

Last Updated

January 10, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03018301

Brief Title

Intravenous Ketamine and Postoperative Pain Following Cesarean Section.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamine group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

Ketalar

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Normal saline

Intervention Description

will receive intravenous 20 ml of normal saline, delivered over 10 minutes.

Primary Outcome Measure Information:

Title

• Number of Subjects Requiring Supplemental Analgesia

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Cumulative morphine/paracetamol

Time Frame

24 hours postoperative

Title

Number of subjects reporting nausea, vomiting

Time Frame

24 hours postoperative

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abdelrady S Ibrahim, MD

Phone

00201026249924

aradys2004@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hamdy A Yousef, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Israa M Sayed

Organizational Affiliation

Assiut University

Official's Role

Study Chair

Facility Information:

Facility Name

Assiut university faculty of medicine

City

Assiut

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abdelrady S Ibrahim, MD

Phone

00201026249924

aradys2004@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

17459695

Citation

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. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.

Results Reference

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