AnalgesiaTABNCT05785377
Neostigmine as an Adjuvant in Tranversus Abdominis Plane (TAP) Block in Cesarean Section Under Spinal Anesthesia
A study testing Bupivacaine-Neostigmine and Bupivacaine in people with Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine-Neostigmine and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2027to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 19 to 40 years old
- American Society of Anesthesiologists (ASA) physical status II patients
- Singleton pregnancies with a gestational age of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
Who cannot join
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Inability to comprehend or participate in the pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drug used in the study.
- Any hypertensive disorders of pregnancy.
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- Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
- Significant cardiovascular, renal or hepatic abnormalities.
- Patients with history of opioid intake, drug abusers or psychiatric patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura University-Emergency hospital-ICU
El Mansoura, Mansoura, 35511
About this study
Official title: Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
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.
Read the detailed description
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.
- Conditions
- Analgesia
- Being tested
- Bupivacaine-Neostigmine, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-NeostigmineDrug
20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg)
BupivacaineDrug
20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bupivacaine |
| 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 Receives: Drug: Bupivacaine-Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of the first postoperative analgesic requirement
during the first 24 postoperative hours
Measured: during the first 24 postoperative hours
Secondary outcomes (8)
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
mg
Measured: during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest
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
Measured: 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
Measured: during the first 24 postoperative hours
Mean arterial blood pressure (MBP)
mmHg
Measured: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)
beat per minute
Measured: 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
Measured: during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
incidence
Measured: during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
Measured: during the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Dec 2027 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785377
- Sponsor's protocol ID
- TAP-neostigmine
- Acronym
- TAB
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
- ClinicalTrials.gov ID
- NCT05785377
- Acronym / sponsor ID
- TAB / TAP-neostigmine
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group (Group-B) | Placebo comparator | Drug: BupivacaineAfter 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 | Drug: Bupivacaine-NeostigmineAfter 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 |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 19 to 40 years old
- American Society of Anesthesiologists (ASA) physical status II patients
- Singleton pregnancies with a gestational age of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
Key exclusion criteria (9 listed)
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Inability to comprehend or participate in the pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drug used in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-Neostigmine20 mL bupivacaine 0.25% plus 1 mL Neostigmine (500 mcg) | Drug | Bupivacaine-Neostigmine group (Group-BN) |
| Bupivacaine20 mL bupivacaine 0.25% plus 1 mL normal saline 0.9% | Drug | Bupivacaine group (Group-B) |
Primary outcome
The time of the first postoperative analgesic requirement
Time frame: during the first 24 postoperative hours
during the first 24 postoperative hours
8 secondary outcomes
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement
Time frame: during the first 24 postoperative hours
Mean arterial blood pressure (MBP)
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia
Time frame: during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
Time frame: during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
Time frame: during the first 24 postoperative hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine-Neostigmine and Bupivacaine in people with Analgesia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha AboZeid, MD (02-01019216192, mahazed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of the first postoperative analgesic requirement (time frame: during the first 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.