Comparative study between efficacy of Morphine and Morphine with Ketamine in neuropathic pain in cancer palliative patient: Randomised prospective study

Background and Rationale

Pain associated with cancer is a significant issue that affects patients’ quality of life and is difficult to treat. Refractory cancer pain is a significant proportion of patients, and pain management can enhance cancer therapy and improve patients’ quality of life. The World Health Organisation recommends a three-step analgesic ladder for managing pain associated with cancer. Opioids like morphine are typically used as the first-line treatment for neuropathic pain in advanced cancer patients. However, many patients may not receive complete pain relief. In some cases, a combination of ketamine and morphine has been shown to be safe and effective. Ketamine, a noncompetitive antagonist of the N-methy-D-aspartate (NMDA) receptor, has been shown to improve opioid-induced antinociception, lessen hyperalgesia, and decrease morphine intake when mixed with other drugs. However, it is unclear how opioid systems contribute to ketamine analgesia in humans. Ketamine’s anti-inflammatory properties, such as inhibiting the release of proinflammatory cytokines, may influence pain conditions. Morphine, an opioid analgesic, is a cornerstone in cancer pain management, targeting the central nervous system’s opioid receptors. However, neuropathic pain often involves mechanisms beyond opioid responsiveness. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has shown promise in enhancing opioid effectiveness and mitigating neuropathic pain by modulating central sensitization. This study aims to explore whether adding ketamine to morphine provides superior pain relief compared to morphine alone, considering factors like intensity, duration, and quality of pain.

AIM AND OBJECTIVES

Aim:

To evaluate the efficacy of morphine and morphine with ketamine in cancer patient suffering from neuropathic pain.

Objective

PRIMARY OBJECTIVE-To compare pain relief in suffering from neuropathic pain due to cancer with using VAS score at 0day, 1stday, 2ndday, 3rdday, 4thday, 5day, 1week, 2ndweek, 4thweek, 3rdmonth, 6month.

SECONDQRY OBJECTIVE-

To compare requirement of rescue analgesia between two groups.

To compare complication between two groups

MATERIAL AND METHODS

Study setting:

The study will be conducted in Department of Anesthesiology, in collaboration with Department of Surgical Oncology, King Georges Medical University, Lucknow. After getting approval from institutional ethical committee.

Study duration: One year

Study design: Randomized Prospective study

Sample size

Sample size is calculated on the basis of variation in total morphine consumption for controlling pain in two study groups using the formula.

The required sample size determined from these parameters was 30 participants in each group.

Inclusion Criteria:

1. Patient giving consent

2. All adult patients with the age of 18-6 palliative care IPD for neuropathic pain.

3. All patients who have not been treated with agents other than ketamine plus morphine for neuropathic pain.

4. Life expectancy more than 6 months.

Exclusion Criteria:

Patient not giving consent

All patients who have been treated with any other anaesthetic agents other than ketamine plus morphine for neuropathic pain.

Patient with renal diseases.

Very poor Glasgow coma scale patient.

Methodology:

The study will be conducted at King Georges Medical University, Lucknow, after obtaining approval from the ethics committee and patient consent. Patients aged 18-65 with neuropathic pain due to cancer will be randomly divided into two groups: Group A, which uses 1mg morphine every 15 minutes, and Group B, which uses 1mg morphine every 15 minutes, with 0.30 to 0.45 microgram ketamine in fusion.

Group A will be consider as control group

We will admit patient for 5 days and give infusion

We will follow up the patient for upto 6month

Outcomes:

Primary outcome:

The study the comparison of two sets of cases with neuropathic pain in Cancer palliative patient.

Secondary outcome:

To study the patient pain relief, sedation, side effect, life style quality improvement and reduction in Visual Analouge Scale.

Statistical analysis:

SPSS 24th version version and MS Excel will be use for statistical analysis of the data. Continuous variables conforming to a normal distribution will be expressed as mean standard deviation. Counting data will be expressed as number and percentages. The ANOVA, unpaired t test or its non parametric equivalents will be used for within group analysis. The chisquare test will used to compare the proportion data between the groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P less than 0.05 will be considered to be statistically significant.