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

NCT ID: NCT02515422

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group 1, Ketamine

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.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Subcutaneous infiltration of ketamine

Group 2, Bupivacaine

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

Subcutaneous infiltration of bupivacaine

Group 3, Ketamine+Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Subcutaneous infiltration of ketamine

Bupivacaine

Intervention Type: DRUG

Subcutaneous infiltration of bupivacaine

Group 4, Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo (0.9% saline solution)

Intervention Type: DRUG

Interventions

Ketamine

Subcutaneous infiltration of ketamine

Intervention Type: DRUG

Bupivacaine

Subcutaneous infiltration of bupivacaine

Intervention Type: DRUG

Placebo (0.9% saline solution)

Intervention Type: DRUG

Other Intervention Names

Ketalar; Marcaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Huseyin Aksoy

OTHER_GOV

Sponsor Role: lead

Responsible Party

Huseyin Aksoy

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kayseri Educational and Research Hospital

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2014/99

Identifier Type: -

Identifier Source: org_study_id