Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
NCT ID: NCT04887649
Last Updated: 2021-05-14
Study Results
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Basic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2009-03-31
2011-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Patients en treatment whit placebo, salIne solution in peridural cateter
saline solution
4 cc of saline solution in epidural cateter in postpartum
Morphine
Epidural Catheter morphine 2mg
Morphine
morphine 3 mg
Morphine
morphine 2 mg for epidural cateter in postpartum
morphine
Epidurla cateter morphine 3 mg
Morphine
morphine 3 mg
Morphine
morphine 2 mg for epidural cateter in postpartum
Interventions
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Morphine
morphine 3 mg
saline solution
4 cc of saline solution in epidural cateter in postpartum
Morphine
morphine 2 mg for epidural cateter in postpartum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
40 Years
FEMALE
No
Sponsors
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Universidad Nacional de Colombia
OTHER
Responsible Party
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Principal Investigators
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Dario J Perea, Medical
Role: STUDY_CHAIR
Universidad Nacional de Colombia
Locations
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Universidad Nacional; Maternal and Child Institute
Bogotá, , Colombia
Countries
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References
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Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available.
Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
Macarthur A, Imarengiaye C, Tureanu L, Downey K. A randomized, double-blind, placebo-controlled trial of epidural morphine analgesia after vaginal delivery. Anesth Analg. 2010 Jan 1;110(1):159-64. doi: 10.1213/ANE.0b013e3181c30f78. Epub 2009 Nov 12.
Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. doi: 10.1016/j.rapm.2004.11.010.
Behar M, Magora F, Olshwang D, Davidson JT. Epidural morphine in treatment of pain. Lancet. 1979 Mar 10;1(8115):527-9. doi: 10.1016/s0140-6736(79)90947-4.
Davies GK, Tolhurst-Cleaver CL, James TL. Respiratory depression after intrathecal narcotics. Anaesthesia. 1980 Nov;35(11):1080-3. doi: 10.1111/j.1365-2044.1980.tb05047.x.
Soni AK, Miller CG, Pratt SD, Hess PE, Oriol NE, Sarna MC. Low dose intrathecal ropivacaine with or without sufentanil provides effective analgesia and does not impair motor strength during labour: a pilot study. Can J Anaesth. 2001 Jul-Aug;48(7):677-80. doi: 10.1007/BF03016202.
Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.
Darío José PS, Ricardo N, Pedro H, Viviana C, Andrea G, Andrés G et al . Randomized double-blind controlled clinical trial for the evaluation of post-partum analgesia using epidural morphine: analgesic effectiveness of different dose regimes compared with placebo. Rev. colomb. anestesiol. 2012 Apr [cited 2021 May 04] ; 40( 1 ): 8-13. Available from: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-33472012000100004&lng=en. https://doi.org/10.1016/S0120-3347(12)70004-7.
Other Identifiers
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7245408
Identifier Type: -
Identifier Source: org_study_id
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