Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This a clinical trial that evaluates the efficacy and safety of three different doses of morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in elderly patients after a cancer surgery in the lower abdomen
Acute postoperative pain is a common complaint for several days after surgery. However, acute postoperative pain remains even more under controlled in elderly patients, especially those with cognitive impairment and malignancy. Geriatric population is reported to be at higher risk for unwanted side effects from analgesic treatments compared to younger patients due to different major risk factors such as: decline in organ function, polypharmacy, pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids, especially morphine, causing toxicity and adverse effect; they are still the cornerstone treatment of severe acute postoperative pain. Morphine in those patients is very likely to cause toxicity because of accumulation of its active metabolites compared to other opioids with fewer or no active metabolites. Epidural morphine is an effective route for an effective drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily. Regarding clinical outcomes, clinical studies showed a lot of improvements associated with postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best management of acute postoperative pain in elderly patients with the least possibility of adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit University to determine the optimum dose of epidural morphine for the highest control of acute postoperative pain in geriatrics who are planned to have lower abdominal cancer surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D | Placebo Comparator | A total volume of 10 mL injection 5 mL of bupivacaine hydrochloride 0.125% diluted in 5 mL preservative-free normal saline by the hospital pharmacist. |
|
| Group A | Active Comparator | A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 1.5 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist. |
|
| Group B | Active Comparator | A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 3 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist. |
|
| Group C | Active Comparator | A total volume of 10 mL injection: 5 mL of bupivacaine hydrochloride 0.125% with 4 mg of preservative-free morphine diluted in 5 mL preservative-free normal saline by the hospital pharmacist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.5 mg of Morphine Sulfate | Drug | 1.5 mg of Morphine Sulphate will be given epidurally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption. | The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Visual Analog Scale is a visual chart scored from 0 (no pain) to 10 ( the worst pain ever) used by the patient to report the severity of their pain to assess the pain intensity, and all patients were instructed how to evaluate their pain and how to use the patient-controlled analgesia. | 72 hours |
Not provided
Inclusion Criteria:
1. Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery.
2- ASA I and II classifications. 2. Surgeries via infra-umbilical abdominal incision is considered eligible.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diab Hetta, MD | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuit University | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26315638 | Background | McKeown JL. Pain Management Issues for the Geriatric Surgical Patient. Anesthesiol Clin. 2015 Sep;33(3):563-76. doi: 10.1016/j.anclin.2015.05.010. Epub 2015 Jul 3. | |
| 10735794 | Background | Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021. |
Not provided
Not provided
The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request. The data will not be publicly available due to containing information that could compromise research participant privacy/consent.
The data will not be publicly available due to containing information that could compromise research participant privacy/consent.
The data will not be publicly available due to containing information that could compromise research participant privacy/consent.
Not provided
A total of 102 patients were assessed for eligibility. Three of them refused to participate in the study, and three did not meet the inclusion criteria.
The study was conducted at South Egypt Cancer institute and Assiut university hospitals according to Consolidated Standards of Reporting Trials (CONSORT) statement. Patients were recruited from the departments of surgical oncology between March 2020 and June 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A (1.5 mg) | Participants were allocated to receive epidural morphine 1.5 mg group. |
| FG001 | Group B (3 mg) | Participants were allocated to receive epidural morphine 3 mg group. |
| FG002 | Group C (4.5mg) | Participants were allocated to receive epidural morphine 4.5 mg group. |
| FG003 | Group D (0 mg) | Participants were allocated to receive epidural morphine 0 mg group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Incomplete data of eight participants was excluded from the final analysis due to protocol violation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Participants allocated to receive 1.5 mg epidural morphine. |
| BG001 | Group B | Participants allocated to receive 3 mg epidural morphine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Patient-controlled Analgesia (PCA) Morphine Sulphate (MS) Consumption. | The mean total PCA morphine consumption (mg) in the first 72 hr. postoperatively | Main statistical test is ANOVA\t-test to detect the difference of PCA morphine consumption between the four groups. | Posted | Mean | Standard Deviation | mg | 72 hours |
|
72 hours
Postoperative sedation effect of epidural morphine was frequently assessed by Modified Ramsay sedation scale. All-Cause Mortality and serious adverse events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Participants allocated to receive 1.5 mg epidural morphine. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Modified Ramsay Sedation Score; level V | Nervous system disorders | Other | Systematic Assessment | sluggish response. |
This study is limited by focusing on lower abdominal cancer surgeries only; also, it is a single center study. Therefore, the generalizability of our results is limited. Future large studies on different types of surgeries are needed. Due to the vulnerability of older adults, we assessed the balancing dose of epidural morphine versus age only. The relation between the dose of epidural morphine and common comorbidities in this age group should be investigated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Muhammad Shawqi | Assiut University | 01100671067 | +20 | m.shawqi@med.au.edu.eg |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2020 | Jan 17, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D000077330 | Saline Solution |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
This randomized, double blinded, clinical trial was approved by the local ethics committee of faculty of medicine, Assuit University, Assuit, Egypt. The maximum total PCA morphine consumption was 12 ± 16 mg while in healthy controls was 70± 35 mg. We aim to enroll at least 60-80 participants considering the following assumptions:
Not provided
Not provided
Not provided
| Normal saline | Drug | Normal saline will be given epidurally. |
|
|
| 3 mg of Morphine Sulfate | Drug | 3 mg of Morphine Sulphate will be given epidurally. |
|
|
| 4.5 mg of Morphine Sulfate | Drug | 4.5 mg of Morphine Sulphate will be given epidurally. |
|
|
| Modified Ramsay Sedation Scale |
It is an six-point scale informed by degree of responsiveness to verbal and tactile stimulus where awake levels were as follows: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = response to command, and asleep levels were dependent on the patient's response to a light glabellar tap or loud auditory stimulus; IV = brisk response; V = a sluggish response; and VI = no response |
| Modified Ramsay Sedation Scale at 2 hours postoperative |
| Nausea Score | It is a subjective scale to assess the nauseating side effects of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Nausea scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| 72 hours |
| Vomiting Score | It is a subjective scale to assess the vomiting as a side effect of epidural morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Vomiting scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| 72 hours |
| Pruritus Score | It is a subjective scale to assess the pruritus as a side effect of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Pruritus scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| 72 hours |
| BG002 | Group C | Participants allocated to receive 4.5 mg epidural morphine. |
| BG003 | Group D | Participants allocated to receive 0 mg epidural morphine. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural. | Count of Participants | Participants |
|
| Region of Enrollment | Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural. | Number | participants |
|
| Body Mass Index | Incomplete data of eight participants was excluded from the final analysis due to protocol violation. In group D, one was excluded due to failed epidural, and the other was excluded due to erroneous intake of IV fentanyl. In group A, one was excluded due to failed epidural, and the other was excluded due to unresectable tumor. In group B, one was excluded due to failed epidural, and the other patient was excluded due to redo of surgery. In group C, two were excluded due to failed epidural. | Mean | Standard Deviation | kg/m^2 |
|
| Group C |
Participants allocated to receive 4.5 mg epidural morphine. |
| OG003 | Group D | Participants allocated to receive 0 mg epidural morphine. |
|
|
| Secondary | Visual Analog Scale | Visual Analog Scale is a visual chart scored from 0 (no pain) to 10 ( the worst pain ever) used by the patient to report the severity of their pain to assess the pain intensity, and all patients were instructed how to evaluate their pain and how to use the patient-controlled analgesia. | Main statistical test is ANOVA\t-test to detect the difference of between the four groups. | Posted | Mean | Standard Deviation | units on a scale | 72 hours |
|
|
|
| Secondary | Modified Ramsay Sedation Scale | It is an six-point scale informed by degree of responsiveness to verbal and tactile stimulus where awake levels were as follows: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = response to command, and asleep levels were dependent on the patient's response to a light glabellar tap or loud auditory stimulus; IV = brisk response; V = a sluggish response; and VI = no response | Main statistical test is ANOVA\t-test to detect the difference between the four groups. | Posted | Mean | Standard Deviation | score on a scale | Modified Ramsay Sedation Scale at 2 hours postoperative |
|
|
|
| Secondary | Nausea Score | It is a subjective scale to assess the nauseating side effects of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Nausea scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| Posted | Mean | Standard Deviation | scores on a scale | 72 hours |
|
|
|
| Secondary | Vomiting Score | It is a subjective scale to assess the vomiting as a side effect of epidural morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Vomiting scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| Main statistical test is ANOVA\t-test to detect the difference of between the four groups. | Posted | Mean | Standard Deviation | score on a scale | 72 hours |
|
|
|
| Secondary | Pruritus Score | It is a subjective scale to assess the pruritus as a side effect of morphine at eight time points (0, 2, 8, 16, 24, 36, 48 and 72 h). The 72-hour score for this side effect was the sum of these eight scores. Pruritus scores were recorded on a scale with a minimum of 0 to a maximum of 2; where: 0 was recorded if the side effect was absent;
| Main statistical test is ANOVA\t-test to detect the difference of between the four groups. | Posted | Mean | Standard Deviation | score on a scale | 72 hours |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 22 |
| EG001 | Group B | Participants allocated to receive 3 mg epidural morphine. | 0 | 0 | 0 | 0 | 0 | 22 |
| EG002 | Group C | Participants allocated to receive 4.5 mg epidural morphine. | 0 | 0 | 0 | 0 | 1 | 22 |
| EG003 | Group D | Participants allocated to receive 0 mg epidural morphine. | 0 | 0 | 0 | 0 | 0 | 22 |
|
Not provided
Not provided
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |