Cesarean SectionPhase 2/3NCT06513013
MgSO4 as Adjuvants to Bupivacaine vs Neostigmine in TAP Block in Cesarean Section
A Phase 2/3 study testing transversus abdominis plane (TAP) block in cesarean section, Magnesium sulfate and Neostigmine in people with Cesarean Section, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- transversus abdominis plane (TAP) block in cesarean section, Magnesium sulfate and Neostigmine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 18 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Singleton pregnencies with a gestational age of at least 37 weeks
- American society of anesthesiologists (ASA) physical state I , II
- patients undergoing spinal anesthesia for cesarean delivery via Pfannenstiel incision with exteriorization of the uterus.
Who cannot join
- Patient's refusal
- Age < 19 or > 40 years
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Cardio-respiratory conditions
- Convulsions
Show all 9Show fewer
- Inability to comprehend or participate in the pain scoring system.
- Bleeding diathesis
- Known allergy to any drugs used in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Magnesium Sulphate Versus Neostigmine as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane (TAP) Block as Postoperative Analgesia in Cesarean Section
The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.
Read the detailed description
Caesarean section (CS) is one of the most operations in the world. Effective postoperative analgesia after it is very important because it encourages breast feeding and facilitates early ambulation and recovery. Postoperative analgesia is too important to prevent unwanted side effects such as venous thromboembolism, respiratory complications and increased hospital stay.Post Caesarean discomfort and pain is expected; so, the analgesic regimen should assure safe and efficient sedation. Commonly, opioids and NSAIDs are used for post caesarean pain relief. While dose dependent respiratory depression is the most discomforting side effect, other insignificant side effects such as gastrointestinal upset, pruritus and urinary retention can be annoying during the first hours of puerperium. The transversus abdominus plane (TAP) block has been used for postoperative pain relief in different abdominal surgeries as part of the multimodal anesthetic approach.It creates satisfactory somatic anesthesia with no visceral blockade. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia .This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle, which is marked by the lumbar Petit triangle. The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone. Several adjuvants, including opioids, alpha 2 agonists,Neostigmine, N-methylD-aspartate (NMDA) receptor antagonists, and other drugs, have been utilized to extend the duration of blocks . Opioids are by far the most often used adjuvants, but they accompany a host of unpleasant side effects, such as respiratory depression, drowsiness, nausea, and vomiting. In some studies, using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia .
MgSO4 is an N-methyl-D-aspartate (NMDA) receptor antagonist. It acts by non-competitive antagonism blocking the voltage-dependent ion channels.
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
- Conditions
- Cesarean Section
- Being tested
- transversus abdominis plane (TAP) block in cesarean section, Magnesium sulfate, Neostigmine
- Keywords
- TAP, mg sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane (TAP) block in cesarean sectionProcedure or surgery
.an intravenous (IV) access will be secured . Standard ASA monitoring will be instituted which include(SpO2), ECG and (NIBP) . At the end of surgery , a bilateral USG-guided TAP block will be carried out under strict aseptic precautions, and 20 mL of study solution was injected into each side. After draping the abdominal region between the 12th rib and anterior superior iliac crest with the umbilicus in the center, the external oblique muscle, internal oblique muscle, transversus abdominis muscle , and their fascia will be located beneath the skin and subcutaneous tissue using a linear high-frequency probe 6-13 Megahertz of the SonoSite Micromax machine. A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered.
Magnesium sulfateDrug
25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 250 mg of MgSO4) to keep the total volume the same in both group
NeostigmineDrug
25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 500 mcg neostigmine.
A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered. Following the affirmation of a hypoechoic region on the USG image, the study solutions will be injected as per group allocation. Postoperatively,both groups of patients received an injection of paracetamol 1gm intravenously every 8th hourly as a part of multimodal analgesia and the patients will be evaluated for pain, nausea or vomiting in the post anaesthesia care unit at time 0 (time of completion of TAP block), 2, 4, 6,12 and 24 h by an investigator blinded to the group assignment. Whenever the NRS >4, Nalbuphine 0.1 mg/kg IV will be administered as a rescue analgesic.
| Study group | Role | What they receive |
|---|---|---|
| Group M "bupivacaine + normal saline + MgSO4" | Active comparator | will receive 25 ml volume on each side ( 20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 250 mg of MgSO4 ) Receives: Procedure: transversus abdominis plane (TAP) block in cesarean section; Drug: Magnesium sulfate |
| Group D "bupivacaine + normal saline + Neostigmine" | Active comparator | will receive 25 ml volume on each side ( 20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 500 mcg of Neostigmine Receives: Procedure: transversus abdominis plane (TAP) block in cesarean section; Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparasion of Postoperative NRS score for 24 hours between the two groups
NRS Score: used to assess pain intensity (13). It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible (Figure 2). This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.
Measured: 24 hours postoperative
Secondary outcomes (5)
postoperative hemodynamic parameters
Hemodynamic parameters including HR
Measured: 24 hours postoperative
time required for the first rescue analgesia
the time at wich the patient demand analgesia will be record for each patient
Measured: 24 hours postoperative
total amount of rescue analgesic consumption duringfirst 24 hours postoperatively
total amount of rescue analgesic consumption duringfirst 24 hours postoperatively
Measured: 24 hours postoperative
patient satisfacation score
five-point likert scale: to evaluate the patient satisfacation regarding the
to evaluate the patients' satisfaction regarding the whole procedure at the end of the postoperative 24 hours. It ranged from (1=very satisfied, 2=satisfied, 3=neither satisfied nor dissatisfied, 4=dissatisfied, 5=very dissatisfied)
Measured: 24 hours postoperative
PONV intensity by postoperatively:
The number of attacks of nausea for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h and will be recorded as yes/no.
- The number of attacks of vomiting for 24 h will be assessed at 0.5, 1, 2, 4, 6, 12 and 24 h postoperatively and will be recorded as yes/no.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start20 Dec 2023
- Primary completion18 Jan 2026
- Study completion18 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfarouk Ayman Farouk Omar, Assiut University
- Investigators
- Zain Alabdin Zaree Hassan, Study chair, Assiut UniversityNashwa Farouk Abdel Hafez, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513013
- Sponsor's protocol ID
- TAP in cs using us
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kapral S, Gollmann G, Waltl B, Likar R, Sladen RN, Weinstabl C, Lehofer F. Tramadol added to mepivacaine prolongs the duration of an axillary brachial plexus blockade. Anesth Analg. 1999 Apr;88(4):853-6. doi: 10.1097/00000539-199904000-00032.
PubMed 10195537Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.
PubMed 31649394Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
PubMed 20216023
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Magnesium Sulphate Versus Neostigmine as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane (TAP) Block as Postoperative Analgesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT06513013
- Acronym / sponsor ID
- TAP in cs using us
- Conditions
- Cesarean Section
- Keywords
- TAP, mg sulphate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Jan 2026 (actual)
- First posted
- 22 Jul 2024 (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.
The aim of this study is to compare the duration of analgesia obtained by addition of Neostigmine versus MgSO4 as adjuvants to bupivacaine in TAP block in patients undergoing Cesarean Section and to evaluate postoperative analgesic requirements, side effects and level of patient satisfaction.
Detailed description
Caesarean section (CS) is one of the most operations in the world. Effective postoperative analgesia after it is very important because it encourages breast feeding and facilitates early ambulation and recovery. Postoperative analgesia is too important to prevent unwanted side effects such as venous thromboembolism, respiratory complications and increased hospital stay.Post Caesarean discomfort and pain is expected; so, the analgesic regimen should assure safe and efficient sedation. Commonly, opioids and NSAIDs are used for post caesarean pain relief. While dose dependent respiratory depression is the most discomforting side effect, other insignificant side effects such as gastrointestinal upset, pruritus and urinary retention can be annoying during the first hours of puerperium. The transversus abdominus plane (TAP) block has been used for postoperative pain relief in different abdominal surgeries as part of the multimodal anesthetic approach.It creates satisfactory somatic anesthesia with no visceral blockade. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia .This block implies administering local anesthetic between the internal oblique muscle and transversus abdominis muscle, which is marked by the lumbar Petit triangle. The primary drawback of single-shot regional blocks is their short duration of action when administered with local anesthetic alone. Several adjuvants, including opioids, alpha 2 agonists,Neostigmine, N-methylD-aspartate (NMDA) receptor antagonists, and other drugs, have been utilized to extend the duration of blocks . Opioids are by far the most often used adjuvants, but they accompany a host of unpleasant side effects, such as respiratory depression, drowsiness, nausea, and vomiting. In some studies, using alpha 2 agonists such as Dexmedetomidine and Clonidine has been related to drowsiness and bradycardia .
MgSO4 is an N-methyl-D-aspartate (NMDA) receptor antagonist. It acts by non-competitive antagonism blocking the voltage-dependent ion channels.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M "bupivacaine + normal saline + MgSO4" | Active comparator | Procedure: transversus abdominis plane (TAP) block in cesarean section, Drug: Magnesium sulfatewill receive 25 ml volume on each side ( 20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 250 mg of MgSO4 ) |
| Group D "bupivacaine + normal saline + Neostigmine" | Active comparator | Procedure: transversus abdominis plane (TAP) block in cesarean section, Drug: Neostigminewill receive 25 ml volume on each side ( 20 ml of 0.25% bupivacaine plus 5 ml of normal saline containing 500 mcg of Neostigmine |
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
- Singleton pregnencies with a gestational age of at least 37 weeks
- American society of anesthesiologists (ASA) physical state I , II
- patients undergoing spinal anesthesia for cesarean delivery via Pfannenstiel incision with exteriorization of the uterus.
Key exclusion criteria (9 listed)
- Patient's refusal
- Age < 19 or > 40 years
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Cardio-respiratory conditions
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 |
|---|---|---|
| transversus abdominis plane (TAP) block in cesarean section.an intravenous (IV) access will be secured . Standard ASA monitoring will be instituted which include(SpO2), ECG and (NIBP) . At the end of surgery , a bilateral USG-guided TAP block will be carried out under strict aseptic precautions, and 20 mL of study solution was injected into each side. After draping the abdominal region between the 12th rib and anterior superior iliac crest with the umbilicus in the center, the external oblique muscle, internal oblique muscle, transversus abdominis muscle , and their fascia will be located beneath the skin and subcutaneous tissue using a linear high-frequency probe 6-13 Megahertz of the SonoSite Micromax machine. A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered. | Procedure or surgery | Group D "bupivacaine + normal saline + Neostigmine", Group M "bupivacaine + normal saline + MgSO4" |
| Magnesium sulfate25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 250 mg of MgSO4) to keep the total volume the same in both group | Drug | Group M "bupivacaine + normal saline + MgSO4" |
| Neostigmine25ml volume on each side (20ml of 0.25% bupivacaine plus 5ml of normal saline containing 500 mcg neostigmine. A 22-gauge spinal needle will be advanced using the in-plane technique at the anterior axillary line, and the precise position of the needle tip between the internal oblique and transverse abdominis muscle will be visualized. To expand the plane, 2 mL of normal saline will be administered. Following the affirmation of a hypoechoic region on the USG image, the study solutions will be injected as per group allocation. Postoperatively,both groups of patients received an injection of paracetamol 1gm intravenously every 8th hourly as a part of multimodal analgesia and the patients will be evaluated for pain, nausea or vomiting in the post anaesthesia care unit at time 0 (time of completion of TAP block), 2, 4, 6,12 and 24 h by an investigator blinded to the group assignment. Whenever the NRS >4, Nalbuphine 0.1 mg/kg IV will be administered as a rescue analgesic. | Drug | Group D "bupivacaine + normal saline + Neostigmine" |
Primary outcome
comparasion of Postoperative NRS score for 24 hours between the two groups
Time frame: 24 hours postoperative
NRS Score: used to assess pain intensity (13). It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible (Figure 2). This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.
5 secondary outcomes
postoperative hemodynamic parameters
Time frame: 24 hours postoperative
time required for the first rescue analgesia
Time frame: 24 hours postoperative
total amount of rescue analgesic consumption duringfirst 24 hours postoperatively
Time frame: 24 hours postoperative
patient satisfacation score
Time frame: 24 hours postoperative
PONV intensity by postoperatively:
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 10195537Kapral S, Gollmann G, Waltl B, Likar R, Sladen RN, Weinstabl C, Lehofer F. Tramadol added to mepivacaine prolongs the duration of an axillary brachial plexus blockade. Anesth Analg. 1999 Apr;88(4):853-6. doi: 10.1097/00000539-199904000-00032.
- Background: PubMed 31649394Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.
- Background: PubMed 20216023Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
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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. This study is not recruiting at the moment.
Zain Alabdin Zaree Hassan study chair
Assiut University
Nashwa Farouk Abdel Hafez study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transversus abdominis plane (TAP) block in cesarean section, Magnesium sulfate and Neostigmine in people with Cesarean Section, run by Assiut 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: finished, as of the sponsor's last update on 31 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparasion of Postoperative NRS score for 24 hours between the two groups (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513013, which also lists 3 linked publications.
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 31 Mar 2026.