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Intrathecal Nalbuphine is a Comparable Safer Alternative to Fentanyl for Intraoperative Pain Management During Uterine Exteriorization

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ClinicalTrials.gov Identifier: NCT04689217
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Sherif Abdullah Mohamed, Cairo University

Tracking Information
First Submitted Date  ICMJE December 26, 2020
First Posted Date  ICMJE December 30, 2020
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE January 1, 2021
Actual Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
intraoperative pain control [ Time Frame: 30 minutes after baby delivery ]
- The visual analog scale (VAS) for visceral abdominal pain in all groups after uterine exteriorization.VAS from 0 to 10 with 0 equal no pain and 10 equal the severist pain ever
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2020)
intraoperative pain control [ Time Frame: 30 minutes after baby delivery ]
- The visual analog scale (VAS) for visceral abdominal pain in all groups after uterine exteriorization
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Nalbuphine is a Comparable Safer Alternative to Fentanyl for Intraoperative Pain Management During Uterine Exteriorization
Official Title  ICMJE Intrathecal Nalbuphine is a Comparable Safer Alternative to Fentanyl for Intraoperative Pain Management During Uterine Exteriorization in Cesarean Section. A Randomized Controlled Trial.
Brief Summary

In case of cesarean section (CS) delivery, spinal anesthesia is the best anesthetic choice. It is simple to perform with rapid onset of anesthesia and lower incidence of failed block. Spinal anesthesia avoids the risk of aspiration, the neonatal depressant effect that may occur with general anesthesia (GA), and provides postoperative analgesia, however, spinal anesthesia has a lesser control on the level of blockade, may give insufficient visceral pain block and may be associated with nausea and vomiting especially during peritoneal traction, closure and uterine manipulation, exteriorization and rotation. A previous study reported nausea and vomiting in up to 70.5% patients in the spinal group while the incidence of moderate to severe pain was more frequent in exteriorized uterus patients.

Increasing the dosage of intrathecal local anesthetic may contribute to a decrease in the occurrence of intraoperative visceral pain, but at the cost of the risk and adverse effects of greater blockade.A variety of adjuvants have been used to prevent these disadvantages. The commonly used adjuvants include opioids; α2 stimulants such as clonidine and dexmedetomidine; NMDA receptor antagonist such as ketamine; GABA receptor agonists such as midazolam.

The added intrathecal opioids as fentanyl and nalbuphine to local anesthetics give a sufficient intraoperative visceral analgesia when they were used in C.S., with less sympathetic block and hemodynamic effect, and reduces the need for intraoperative analgesics with prolongation of postoperative analgesia.

Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects. It was synthesized attempting to produce analgesia without the undesirable side effects of mu agonist. Also, its combination with mu agonist opioids was tried by many researchers to decrease the incidence and severity of the common mu agonist side effects (respiratory depression, undesirable sedation, pruritus, bradycardia, nausea, vomiting and urinary retention), plus it can antagonize spinal induced shivering. Meanwhile, the benefits of both kappa and mu analgesia can be obtained.

Few studies compared the effects of intrathecal nalbuphine (opioid agonist-antagonist) and fentanyl (opioid agonist) as adjuvants to bupivacaine in spinal blocked for CS with variable results. However, they didn't compare their ability to control the visceral pain aggravated by uterine exteriorization in cesarean section under spinal anesthesia. This study will try to answer the question is nalbuphine effective enough in such scenario to be used routinely as a safer alternative to fentanyl, which is the opioid in common practice added to bupivacaine?

Aim of the study:

To compare the ability of the used doses in the study of intrathecal nalbuphine and intrathecal fentanyl to control the visceral pain aggravated by uterine exteriorization in cesarean section under spinal anesthesia

Objectives:

  • To evaluate the visual analog scale (VAS) for visceral abdominal and shoulder pain every 5 minutes and the maximum score will be recorded for 30 minutes from the time of baby delivery.
  • To calculate the total fentanyl used for VAS ⩾ 4
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pain, Acute
Intervention  ICMJE Drug: intrathecal drug injection

All patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.

The patients will be divided equally into 3 groups according to the additive (fentanyl, nalbuphine or placebo), and all patients will receive the local anesthetic dose of 0.5% heavy bupivacaine according to weight and height

Other Name: spinal opioid injection
Study Arms  ICMJE
  • Experimental: Group F
    will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml fentanyl (25 μg)
    Intervention: Drug: intrathecal drug injection
  • Experimental: Group N
    will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.8 mg nalbuphine hydrochloride
    Intervention: Drug: intrathecal drug injection
  • Placebo Comparator: Group C
    will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline
    Intervention: Drug: intrathecal drug injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2020)
135
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2021
Actual Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • forty-two female patients
  • ASA physical status I or II,
  • age between 20 and 45 years,
  • weight between 60 and 100 kg
  • height between 160 and 180 cm

Exclusion Criteria:

  • ASA III or IV,
  • patient refusal,
  • hypotensive patients,
  • infection at the site of injection,
  • coagulopathy
  • weight <60 and > 100 kg,
  • anticoagulant medications,
  • pre-existing neurological disease.
  • uncooperative patients,
  • cardiac disorder
  • respiratory disorder
  • allergy to local anesthetics.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: cesarean section patients
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04689217
Other Study ID Numbers  ICMJE N- 26 / 2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: not to share
Responsible Party Sherif Abdullah Mohamed, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP