IMI: Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo

Sponsor

Universidad Nacional de Colombia (Other)

Overall Status

Completed

CT.gov ID

NCT04887649

Collaborator

(none)

114

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Morphine Drug: saline solution Drug: Morphine	Phase 3

Detailed Description

The intervention is the epidural administration of morphine in two doses 2mg and 3mg different vs placebo 1 hour after delivery care maternal vaginal in patients who received epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations of the different doses vs placebo.

In the analysis to determine whether the proposed levels are effective for postpartum pain control was carried out by determining the differences between experimental groups and control group, and in examining the statistical significance of the differences found by applying the relevant tests according to whether the variable is normally distributed or not.

The main variables analyzed were:

rating of pain intensity, number of analgesics required required dose of analgesics used to achieve adequate control pain, number of pain episodes and percentage of patients free of these episodes, duration of action of the dose used.

Similar analysis was determined by the incidence of side effects, in particular those described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory depression

Were classified into three groups: two experimental and one control group.

Experimental Group 1 will receive 10 ml of solution prepared as follows:

2 mg of morphine diluted in 0.9% normal saline

Experimental Group 2 will receive 10 ml of solution prepared as follows:

3 mg of morphine diluted in 0.9% normal saline

The control group will receive 10 ml of normal saline (SSN).

The randomization codes were kept in a sealed envelope so individual, and the envelopes were guarded and uncovered after a eligible to participate in the study agreed to be included and signed the informed consent.

Anesthesia Technique for the Study

In ASA II patients in labor who were initiates of labor analgesia with epidural catheter has been placed ideally at the level of L3-L4 (Tuohy catheter conventional number 18, introduced by loss of resistance technique) .

The patients were started a conventional dose of analgesia with bupivacaine 0.5% + fentanyl 100mcg 10mg 10cc carried in a bolus. Administered bupivacaine + 10 mg bolus of fentanyl 100mcg as needed to strengthen the epidural analgesia

or Infusion Bupivacaine 0.125% + Fentanyl 100mcg%

In a 10cc bolus then 8-16CC hours

In patients 1 hour after having her expulsive morphine were previously applied in laboratory and packaged in disregard of the anesthesiologist applied morphine 2mg - 3mg or saline placebo.

The dose will be applied 1 hour after birth in search of having no residual analgesic effect of local anesthetic and opioid epidural analgesia initially applied.

All patients will be managed with conventional analgesia performed in the institution acetaminophen 1 g every 6 hours VO

If additional merit the first choice analgesic diclofenac 75mg IM is, if no answer will apply a dose of 100mg tramadol or morphine IV in titrated only if warranted more analgesia.

For all patients will have availability of naloxone in case of respiratory depression.

Patients will be observed for 24 hours with monitoring the consumption of other analgesics, pain visual analog scale, which is evaluated at the time of the application of morphine, 2h, 4h, 6h 12h and 24h after application of morphine. Also evaluated variables such as development of pruritus, nausea, vomiting, urinary retention and assessment of respiratory rate.

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Patients en treatment whit placebo, salIne solution in peridural cateter	Drug: saline solution 4 cc of saline solution in epidural cateter in postpartum Other Names: Random code numbers
Active Comparator: Morphine Epidural Catheter morphine 2mg	Drug: Morphine morphine 3 mg Other Names: Random code numbers Drug: Morphine morphine 2 mg for epidural cateter in postpartum Other Names: Random code numbers
Active Comparator: morphine Epidurla cateter morphine 3 mg	Drug: Morphine morphine 3 mg Other Names: Random code numbers Drug: Morphine morphine 2 mg for epidural cateter in postpartum Other Names: Random code numbers

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Patients en treatment whit placebo, salIne solution in peridural cateter

Drug: saline solution

4 cc of saline solution in epidural cateter in postpartum

Other Names:

Random code numbers

Active Comparator: Morphine

Epidural Catheter morphine 2mg

Drug: Morphine

morphine 3 mg

Other Names:

Random code numbers

Drug: Morphine

morphine 2 mg for epidural cateter in postpartum

Other Names:

Random code numbers

Active Comparator: morphine

Epidurla cateter morphine 3 mg

Drug: Morphine

morphine 3 mg

Other Names:

Random code numbers

Drug: Morphine

morphine 2 mg for epidural cateter in postpartum

Other Names:

Random code numbers

Outcome Measures

Primary Outcome Measures

The analgesic efficacy: : pain intensity rating [The first 24 hours after administration]
The analgesic efficacy at controlling pain after delivery

Secondary Outcome Measures

the incidence of side effects [the first 24 hours after administration]
In particular those described in the literature, such as pruritus, nausea, vomiting, urinary retention and respiratory depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients postpartum vaginal conventional analgesia management of your labor
ASA II
Do not include patients with history of allergy to morphine.
Patients who agreed to be included in the study but did not sign informed consent.

Exclusion Criteria:

Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.