Intrathecal Nalbuphine Versus Midazolam in Cesarean Section

Cesarean Section Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918187
• Other study ID #: 5305
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 1, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Cesarean Section Pain

Intervention

Drug:
• Bupivacaine
compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
• Nalbuphine
compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
• Midazolam
compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .

Locations

Country	Name	City	State
Egypt	Olfat Abd Elmoniem Ibrahem Amin	Zagazig	Eygpt/zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective analgesic time	the time start from intrathecal injection to the first analgesic dose.	up to six hours postoperative
Primary	Total postoperative analgesic dose .	the analgesic dose consumed	24 hours
Primary	Onset of sensory and motor block	the time of onset of sensory and motor block	up tp five minutes after intrathecal injection
Primary	duration of sensory and motor block	the time of duration of sensory and motor block	up to five hours postoperative
Secondary	Sedation score	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	one hour during surgery
Secondary	Apgar score	score for baby	1-5 minutes after delivery
Secondary	number of participants with hypotension , bradycardia ,vomiting , nausea , shivering number of participants with hypotension , bradycardia ,vomiting , nausea , shivering	incidence of hypotension , bradycardia ,vomiting , nausea , shivering	up to 24 hours postoperative