Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects.
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of neostigmine as an adjuvant to isobaric bupivacaine inTranversus abdominis plane (TAPB) for postoperative analgesia in cesarean section under spinal anesthesia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine group (Group-B) | Placebo Comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of normal saline (Total volume of 21mL in each side |
|
| Bupivacaine-Neostigmine group (Group-BN) | Active Comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of 500 mcg neostigmine (Total volume of 21mL in each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-Neostigmine | Drug | 20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time of the first postoperative analgesic requirement | during the first 24 postoperative hours | during the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the | mg | during the first 24 postoperative hours |
| The visual analog scale (VAS) scores during rest |
Not provided
Inclusion Criteria:
Exclusion Criteria:
singleton pregnant women with a gestational age of at least 37 weeks
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha AboZeid, MD | Contact | 02-01019216192 | mahazed@mans.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University-Emergency hospital-ICU | El Mansoura | Mansoura | 35511 | Egypt |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into two groups; Group-B and Group-BN according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
Not provided
Not provided
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
| Bupivacaine | Drug | 20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9% |
|
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
| during the first 24 postoperative hours |
| The visual analog scale (VAS) scores during movement | 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively | during the first 24 postoperative hours |
| Mean arterial blood pressure (MBP) | mmHg | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours |
| heart rate (HR) | beat per minute | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours |
| Patient satisfaction about the quality of postoperative analgesia | poor = 1, fair = 2, good = 3, excellent = 4 | during the first 24 postoperative hours |
| The side effects (nausea, vomiting, abdominal colic and lower limb weakness) | incidence | during the first 24 postoperative hours |
| the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome | during the first 24 postoperative hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |