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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04887649
Acronym
IMI
Enrollment
114
Registered
2021-05-14
Start date
2009-03-31
Completion date
2011-04-30
Last updated
2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Epidural opioid, Morphine, Postpartum pain, Analgesia, Perineorraphy

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.

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.

Interventions

DRUGMorphine

morphine 3 mg

DRUGsaline solution

4 cc of saline solution in epidural cateter in postpartum

Sponsors

Universidad Nacional de Colombia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The analgesic efficacy: : pain intensity ratingThe first 24 hours after administrationThe analgesic efficacy at controlling pain after delivery

Secondary

MeasureTime frameDescription
the incidence of side effectsthe first 24 hours after administrationIn particular those described in the literature, such as pruritus, nausea, vomiting, urinary retention and respiratory depression

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026