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NCT Number: NCT03918187

Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

Adequate pain management is important to facilitate the functional recovery and enable the patients for rapid rehabilitation of normal activity .

Various adjuvants were being used with intrathecal bupivacain to prolong & improve postoperative pain relief in patients undergoing cesarean section .

The aim of this study was to compare intrathecal nalbuphine versus intrathecal midazolam in patient undergoing cesarean section. The investigators primary aims were to compare the characteristics of sensory and motor block, the effective analgesic time, and analgesic requirement. Secondary aims were to compare the side effects, sedation score and apgare score.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Olfat Abd Elmoniem Ibrahem Amin

Zagazig, Eygpt/zagazig, 002055, Egypt

About this study

Analgesia is the main point for each patient postoperatively. It is important to provide good analgesia with less hazardous (1). Cesarean section is a painful operation in need for adequate postoperative analgesia (1). Adequate pain management is important to facilitate the functional recovery and enable the patients for rapid rehabilitation of their normal activity (2).

Cesarean section was done under general anesthesia (GA) or regional anesthesia. The subarachnoid blockade is the preferred procedure (3). It avoids the depressant effect of GA on neonate and also the risk of aspiration, with better postoperative pain relief. However the most commonly local anesthetic used, hyperbaric bupivacaine has limited effect lasts for 1.5 - 2 hours (4). Its onset was slow with short duration of postoperative analgesia (3).

Adjuvant drugs added to bupivacaine intrathecally improve the duration and quality of the blockade and prolong the postoperative analgesia (5). Various adjuvants were being used such as alpha2 agonists, neostigmine, opiates, and ketamine etc, yet no drug was identified to specifically inhibit nociception without side effects (6).

Nalbuphine is a synthetic opioid with mixed agonist antagonist effect. It provides a significantly rapid onset of pain relief probably because of its lipophilic properties. It binds to both mu-and kappa receptors, binding of nalbuphine to mu receptors competitively displace other mu-agonists from these receptors without any agonist activity. Therefore decrease the side effects of mu agonist (nausea, vomiting, respiratory depression , urinary retention, pruritis and prolonged sedation) (7). While when binds to kappa receptors nalbuphine has agonist effect (analgesic effect) through the kappa receptors distributed in the brain and spinal cord(1). There were no documented studies of nalbuphine neurotoxicity (5, 8).

Benzodiazepines are used mainly for sedation, anoxiolysis and amnesia. Discovery of their receptors in spinal cord allow the use of midazolam intrathecally for analgesia. Several studies show that the addition of intrathecal midazolam potentiates the analgesic effect of intrathecal bupivacain without significant side effects, or neurotoxicity (9, 10).

There are several studies studied the effect of intrathecal nalbuphine and intrathecal midazolam but to The investigators knowledge no study compares between them.

The aim of this study was to compare intrathecal nalbuphine versus intrathecal midazolam in patient undergoing cesarean section. The investigators primary aims were to compare the characteristics of sensory and motor block, the effective analgesic time, and analgesic requirement. Secondary aims were to compare the side effects, sedation score and apgare score.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • Female gender .
  • Age : 18 - 40 years old .
  • Physical status : ASA II .
  • Elective cesarean section

Exclusion criteria

  • - Patient refusal .
  • History of hypertension or cardiac diseases .
  • Psychiatric disorders .
  • Coagulopathy .
  • Allergy to study drugs .
  • Contraindication to spinal anesthesia .
  • Failure of spinal anesthesia .

Treatment and study plan

Bupivacaine

Drug

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

Nalbuphine

Drug

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

midazolam

Drug

compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

Primary outcomes

  1. Effective analgesic time

    Time frame: up to six hours postoperative

    the time start from intrathecal injection to the first analgesic dose.

  2. Total postoperative analgesic dose .

    Time frame: 24 hours

    the analgesic dose consumed

  3. Onset of sensory and motor block

    Time frame: up tp five minutes after intrathecal injection

    the time of onset of sensory and motor block

  4. duration of sensory and motor block

    Time frame: up to five hours postoperative

    the time of duration of sensory and motor block

Secondary outcomes

  1. Sedation score

    Time frame: one hour during surgery

    score of sedation:

    1= awake and alert 2 = sedated ,respond to verbal stimules 3= sedated respond to a mild physical status 4=sedated respond to a moderate or strong physical stimuls 5= not arousable 5 is the higher value

  2. Apgar score

    Time frame: 1-5 minutes after delivery

    score for baby

  3. number of participants with hypotension , bradycardia ,vomiting , nausea , shivering number of participants with hypotension , bradycardia ,vomiting , nausea , shivering

    Time frame: up to 24 hours postoperative

    incidence of hypotension , bradycardia ,vomiting , nausea , shivering

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Nalbuphine Versus Midazolam as an Adjuvant to Intrathecal Bupivacaine for Postoperative Analgesia in Patients Undergoing Cesarean Section

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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