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

NCT02515422 | Completed Phase 1

• 1 other identifier: 2014/99
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Caesarean Section

Outcome Measures

Primary Outcomes (1)

• Postoperative visual analog scale pain score

  Postoperative 12 hours

Secondary Outcomes (1)

• Postoperative opioid consumption

  Postoperative 12 hours

Study Arms (4)

Group 1, Ketamine

ACTIVE COMPARATOR

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.

Drug: Ketamine

Group 2, Bupivacaine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Group 3, Ketamine+Bupivacaine

ACTIVE COMPARATOR

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

Drug: Ketamine; Drug: Bupivacaine

Group 4, Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (0.9% saline solution)

Interventions

Ketamine DRUG

Subcutaneous infiltration of ketamine

Also known as: Ketalar

Group 1, Ketamine; Group 3, Ketamine+Bupivacaine

Bupivacaine DRUG

Subcutaneous infiltration of bupivacaine

Also known as: Marcaine

Group 2, Bupivacaine; Group 3, Ketamine+Bupivacaine

Placebo (0.9% saline solution) DRUG

Group 4, Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huseyin Aksoy: lead

Study Sites (1)

Kayseri Educational and Research Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-07

Locations

TU (1)