Intrathecal Nalbuphine Versus Midazolam in Cesarean Section
Condition: Cesarean Section Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Bupivacaine; Nalbuphine; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .; compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .; compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
Intervention MeSH terms: Midazolam; Nalbuphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled comparative Double blind randomized study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: nalbuphine; midazolam