Cesarean Section Pain Clinical Trial
Official title:
Nalbuphine Versus Midazolam as an Adjuvant to Intrathecal Bupivacaine for Postoperative Analgesia in Patients Undergoing 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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05276206 -
Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
|
Phase 1 | |
| Completed |
NCT04538391 -
Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief
|
N/A |