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

Huseyin Aksoy

Status and phase: Completed; Phase 1

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine; Drug: Placebo (0.9% saline solution); Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02515422

2014/99

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Group 1, Ketamine

Active Comparator group

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.

Treatment:

Drug: Ketamine

Group 2, Bupivacaine

Active Comparator group

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.

Treatment:

Drug: Bupivacaine

Group 3, Ketamine+Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Drug: Bupivacaine

Group 4, Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (0.9% saline solution)