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Clinical Trials/NCT04689217
NCT04689217
Completed
Not Applicable

Intrathecal Nalbuphine is a Comparable Safer Alternative to Fentanyl for Intraoperative Pain Management During Uterine Exteriorization in Cesarean Section. A Randomized Controlled Trial.

Cairo University1 site in 1 country135 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
intrathecal drug injection
Conditions
Pain, Acute
Sponsor
Cairo University
Enrollment
135
Locations
1
Primary Endpoint
intraoperative pain control
Status
Completed
Last Updated
4 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
May 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sherif Abdullah Mohamed

Lecturer of anesthesia

Cairo University

Eligibility Criteria

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

Arms & Interventions

Group F

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml fentanyl (25 μg)

Intervention: intrathecal drug injection

Group N

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.8 mg nalbuphine hydrochloride

Intervention: intrathecal drug injection

Group C

will receive intrathecal injection of 0.5% hyperbaric bupivacaine plus 0.5 ml normal saline

Intervention: intrathecal drug injection

Outcomes

Primary Outcomes

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

Study Sites (1)

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