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Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Ketamine
Bupivacaine
Placebo (0.9% saline solution)
Sponsored by
Huseyin Aksoy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Caesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton term pregnancy,
  • between 38-41th weeks of gestation,
  • absence of any medical or obstetrical problems.

Exclusion Criteria:

  • multiple pregnancies,
  • intrauterine fetal deaths,
  • active stage of labor,
  • obstetric emergencies such as antepartum hemorrhage, eclampsia and acute fetal distress,
  • special request for general anesthesia,
  • history of allergic reaction or sensitivity to any of the drugs used in the study,
  • reflected anxiety and depression during the cesarean operation,
  • any systemic diseases (chronic hypertension, thyroid diseases, renal or hepatic insufficiency, psychiatric disorders,
  • chronic pain syndrome, epilepsy or intracranial hypertension)
  • medications that would affect the perception of pain,
  • current or past history of narcotic use or a history of narcotic abuse,
  • inability to understand how to score a 10-cm visual analogue scale (VAS) for pain.

Sites / Locations

  • Kayseri Educational and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1, Ketamine

Group 2, Bupivacaine

Group 3, Ketamine+Bupivacaine

Group 4, Placebo

Arm Description

Ketamine, 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA) was administered subcutaneously before the closure of pfannenstiel incision.

Bupivacaine 0.5% 20 mL (100 mg) (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey) was administered subcutaneously before the closure of pfannenstiel incision.

Ketamine 1 mg/kg (Ketalar®) and bupivacaine 0.5% (100 mg) (Marcaine®) were administered subcutaneously before the closure of pfannenstiel incision.

Placebo (0.9% saline solution) was administered subcutaneously before the closure of pfannenstiel incision.

Outcomes

Primary Outcome Measures

Postoperative visual analog scale pain score

Secondary Outcome Measures

Postoperative opioid consumption

Full Information

First Posted
July 29, 2015
Last Updated
August 3, 2015
Sponsor
Huseyin Aksoy
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1. Study Identification

Unique Protocol Identification Number
NCT02515422
Brief Title
Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section
Official Title
Subcutaneous Wound Infiltration of Ketamine is Superior to Bupivacaine in Terms of Pain Perception and Opioid Consumption After Cesarean Section: a Double-blinded Randomized Placebo Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huseyin Aksoy

4. Oversight

5. Study Description

Brief Summary
Aim: To assess the analgesic efficacy of subcutaneous infiltration of ketamine, either alone or as an adjuvant to bupivacaine, following CS and to compare their effects on postoperative pain scores and opioid consumption. Methods: Included patients were allocated to four treatment groups using computer-generated randomization number chart as follows; Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine, Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of bupivacaine 0.5%, Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine+bupivacaine 0.5% and Group 4 (Placebo, n=30) received subcutaneous infiltration of placebo (0.9% saline solution). Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications. VAS scores at resting and on coughing and analgesic consumptions were compared.
Detailed Description
the Group 1 (Ketamine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA). The Group 2 (Bupivacaine, n=30) received subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey). The Group 3 (Ketamine+Bupivacaine, n=30) received subcutaneous infiltration of ketamine 1 mg/kg (Ketalar®) plus subcutaneous infiltration of 20 mL (100 mg) of bupivacaine 0.5% (Marcaine®). The Group 4 (Placebo, n=30) received subcutaneous infiltration of 30 mL placebo (0.9% saline solution). All medications were diluted with sterile 0.9% saline solution to 30 ml solutions in the similar volume and shape syringes and were infiltrated subcutaneously along the skin wound edges and close to the fascia prior to skin closure. There were four separate syringes which were prepared by an anesthesiology technician for four different treatment groups labeled G1, G2, G3 and G4 containing the ketamine, bupivacaine, ketamine plus bupivacaine and normal saline solution. Patients, anesthetist, surgeon, and other medical and nursing staff were blinded to the contents of the medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Caesarean Section

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1, Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine, 1 mg/kg (Ketalar®, 10 mL inj., 50 mg ketamine hydrochloride/ml, Pfizer Drug Company, USA) was administered subcutaneously before the closure of pfannenstiel incision.
Arm Title
Group 2, Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.5% 20 mL (100 mg) (Marcaine®, 20 mL inj. 5 mg bupivacaine hydrochloride/ml, AstraZeneca Drug Company, Turkey) was administered subcutaneously before the closure of pfannenstiel incision.
Arm Title
Group 3, Ketamine+Bupivacaine
Arm Type
Active Comparator
Arm Description
Ketamine 1 mg/kg (Ketalar®) and bupivacaine 0.5% (100 mg) (Marcaine®) were administered subcutaneously before the closure of pfannenstiel incision.
Arm Title
Group 4, Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (0.9% saline solution) was administered subcutaneously before the closure of pfannenstiel incision.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Subcutaneous infiltration of ketamine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Subcutaneous infiltration of bupivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo (0.9% saline solution)
Primary Outcome Measure Information:
Title
Postoperative visual analog scale pain score
Time Frame
Postoperative 12 hours
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Time Frame
Postoperative 12 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: singleton term pregnancy, between 38-41th weeks of gestation, absence of any medical or obstetrical problems. Exclusion Criteria: multiple pregnancies, intrauterine fetal deaths, active stage of labor, obstetric emergencies such as antepartum hemorrhage, eclampsia and acute fetal distress, special request for general anesthesia, history of allergic reaction or sensitivity to any of the drugs used in the study, reflected anxiety and depression during the cesarean operation, any systemic diseases (chronic hypertension, thyroid diseases, renal or hepatic insufficiency, psychiatric disorders, chronic pain syndrome, epilepsy or intracranial hypertension) medications that would affect the perception of pain, current or past history of narcotic use or a history of narcotic abuse, inability to understand how to score a 10-cm visual analogue scale (VAS) for pain.
Facility Information:
Facility Name
Kayseri Educational and Research Hospital
City
Kayseri
Country
Turkey

12. IPD Sharing Statement

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Subcutaneous Wound Infiltration of Ketamine or Bupivacaine Pain Perception After Cesarean Section

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