Clinical trial NCT04887649: Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
Official title: Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor Pain
Keywords: Epidural opioid
Morphine
Postpartum pain
Analgesia
Perineorraphy
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 114
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The analgesic efficacy: : pain intensity rating
timeFrame: The first 24 hours after administration
Secondary outcomes:
measure: the incidence of side effects
timeFrame: the first 24 hours after administration
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Universidad Nacional; Maternal and Child Institute
Study officials:
affiliation: Universidad Nacional de Colombia
name: Dario J Perea, Medical
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
citation: 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.
citation: 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.