Caesarian SectionPhase 3NCT06871033
Ketamine Versus Neostigmine in Ultrasound-Guided Transversus Abdominis Plane Block in Caesarean Section
A Phase 3 study testing TAP block with neostigmine and TAP block with Ketamine in people with Caesarian Section and Postoperative Pain, run by Alexandria University at 1 site in Egypt.
Trial summary
The current study investigates the efficacy and safety of ketamine and neostigmine as adjuvants in transversus abdominis plane blocks for Cesarean sections. The study participants arerandomized into two groups, each receiving either ketamine or neostigmine alongside plain bupivacaine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caesarian Section, Postoperative Pain
- What is being tested?
- TAP block with neostigmine and TAP block with Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Phase 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA physical status I or II patients.
- Patients undergoing elective CS. Exclusion criteria
- Patients undergoing emergent CS.
- Patient refusal.
- Allergy to local anaesthesia or any additive drug.
- Coagulopathy.
Show all 9Show fewer
- Body mass index > 35.
- Peripheral neuropathy or chronic pain syndrome.
- Localized infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Alexandria University
Alexandria, Alexandria Governorate
About this study
Official title: Comparison Between Ketamine and Neostigmine As Adjuvants to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block in Caesarean Section
The current study investigates the efficacy and safety of ketamine and neostigmine as adjuvants in transversus abdominis plane blocks for Cesarean sections. The study participants arerandomized into two groups, each receiving either ketamine or neostigmine alongside plain bupivacaine. Various parameters, including pain intensity, intraoperative and postoperative hemodynamics, rescue analgesia requirements, patient satisfaction, and postoperative complications, are evaluated and compared between the two groups.
Read the detailed description
A prospective, experimental double-blind control study will be conducted in Alexandria Main University Hospital after approval of the medical ethics committee of the Alexandria Faculty of Medicine and a written formal consent will be signed out from patients or their relatives. Patients will be double-blinded randomized into two equal groups (40 patients each) after receiving spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine:
- Group 1: 40 patients received postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side.
- Group 2: 40 patients received postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.
Preoperative assessment and preparation:
- Proper history taking.
- Complete clinical examination.
- Routine laboratory investigations.
- The technique of anaesthesia and visual analog score (VAS) will be explained to patients. The VAS score is a simple and commonly used method to measure pain intensity. It involves a horizontal line, usually 10 centimeters long, with one end representing "no pain" and the other end representing "worst pain imaginable." Patients will be asked to mark a point on the line that corresponds to their current pain level. This will help to understand the severity of pain and to determine the appropriate pain management strategies.
- Additionally, the difference between somatic or parietal pain and visceral pain will be explained to patients. Somatic or parietal pain arises from the outer layers of the body, such as the skin, muscles, and tissues. It is typically well-localized and sharp in nature, and increased with movement. In contrast, visceral pain originates from internal organs and is often described as dull, aching, or cramp-like that does not increase with movement. By understanding these distinctions, patients can better communicate their pain experiences.
Patient preparation:
The patients receive:
- Oral Famotidine 40 mg at night before the day of surgery.
- Ondansetron 4 mg IV immediately before surgery. Monitoring A multichannel monitor (Dräger, Vista 120) will be connected to the patient to display continuous electrocardiography monitoring for heart rate (beat/min) and detection of dysrhythmias, non-invasive arterial blood pressure (NIBP), pulse oxygen saturation (SpO2). Anaesthetic technique All patients undergoing elective CS surgery will receive spinal anaesthesia as the primary anaesthetic technique. Following the completion of the CS surgery, a Transversus Abdominis Plane (TAP) block will be performed to enhance postoperative pain management. Patient will be positioned supine on the operating table and the abdomen will be prepared and draped in a sterile manner to maintain aseptic conditions. Strict sterile techniques will be followed, including the use of sterile gloves, drapes, and local antiseptic solution for skin preparation. The ultrasound probe will be covered with a sterile sheath or barrier to ensure asepsis.
The TAP block will be performed using Sonosite M-turbo ultrasound with high-frequency (10-15 MHz) linear transducer. The skin will be disinfected with antiseptic solution. A linear transducer will be placed in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles will be visualized: external and internal oblique as well as the transversus abdominis muscles. The target is the fascial plane between the internal oblique and the transversus abdominis muscles. The needle will be inserted in the anterior axillary line, and the needle tip will be advanced until it reaches the fascial plane then 20 ml of 0.25% plain bupivacaine and 0.5 mg/kg ketamine will be injected in the first group and 50 microgram neostigmine in the second group under repeated aspiration for every 5 milliliters separating the plane between the internal oblique and transversus abdominis muscles with increased radiotranslucency approximately in the midaxillary line. The identical technique will be repeated on the opposite side.
Over the next 24 hours, all patients received 1 g of paracetamol IV every 8 hour as a part of multimodal analgesia. Measurements
The following parameters will be measured in every patient in the study:
- Vital signs Including heart rate (bpm), and mean arterial blood pressure (mmHg). All previous parameters will be continuously monitored and recorded before starting the surgery, intraoperatively and postoperatively after giving TAP block with adjuvants, at 2, 4, 6, 12, 18, and 24 hours postoperative.
- Pain scoring The visual analog scale (VAS) will be recorded intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively. The rescue analgesia (nalbuphine 6 mg IV) will be used when VAS score ≥ 4.
- Duration of analgesia (hours) Duration of analgesia defined as the time interval after start of the technique till the first need of rescue analgesic (nalbuphine 6 mg IV).
- Total dose of rescue analgesia (mg) Cumulative use of opioid (nalbuphine) in 24 hours.
- Patient satisfaction Patient satisfaction with the pain control will be assessed on a four-point scale as: Excellent, Good, Fair and Poor.
- Complications Any post-operative complication occurred at any time in the 24 hours of the study will be recorded and analyzed accordingly:
- Haemodynamic instability.
- Haematoma at the site of injection.
- Conditions
- Caesarian Section, Postoperative Pain
- Being tested
- TAP block with neostigmine, TAP block with Ketamine
- Keywords
- Ketamine, Neostigmine, TAP block, Caesarian section, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block with neostigmineDrug
40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.
TAP block with KetamineDrug
40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side.
| Study group | Role | What they receive |
|---|---|---|
| TAP block with Ketamine | Active comparator | 40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side Receives: Drug: TAP block with Ketamine |
| TAP block with Neostigmine | Experimental | 40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side. Receives: Drug: TAP block with neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain score
Change From Baseline in Pain Scores on the Visual Analog Scale
Measured: Intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction with the pain control will be assessed on a four-point scale as: Excellent, Good, Fair and Poor.
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 posted11 Mar 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarian SectionStudies of the same condition, open and under way.
- More trials run by Alexandria 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871033
- Sponsor's protocol ID
- 0201931
- Status last verified
- Dec 2023
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ketamine and Neostigmine As Adjuvants to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block in Caesarean Section
- ClinicalTrials.gov ID
- NCT06871033
- Acronym / sponsor ID
- 0201931
- Conditions
- Caesarian Section, Postoperative Pain
- Keywords
- Ketamine, Neostigmine, TAP block, Caesarian section, postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Mar 2025 (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 current study investigates the efficacy and safety of ketamine and neostigmine as adjuvants in transversus abdominis plane blocks for Cesarean sections. The study participants arerandomized into two groups, each receiving either ketamine or neostigmine alongside plain bupivacaine. Various parameters, including pain intensity, intraoperative and postoperative hemodynamics, rescue analgesia requirements, patient satisfaction, and postoperative complications, are evaluated and compared between the two groups.
Detailed description
A prospective, experimental double-blind control study will be conducted in Alexandria Main University Hospital after approval of the medical ethics committee of the Alexandria Faculty of Medicine and a written formal consent will be signed out from patients or their relatives. Patients will be double-blinded randomized into two equal groups (40 patients each) after receiving spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine:
- Group 1: 40 patients received postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side.
- Group 2: 40 patients received postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.
Preoperative assessment and preparation:
- Proper history taking.
- Complete clinical examination.
- Routine laboratory investigations.
- The technique of anaesthesia and visual analog score (VAS) will be explained to patients. The VAS score is a simple and commonly used method to measure pain intensity. It involves a horizontal line, usually 10 centimeters long, with one end representing "no pain" and the other end representing "worst pain imaginable." Patients will be asked to mark a point on the line that corresponds to their current pain level. This will help to understand the severity of pain and to determine the appropriate pain management strategies.
- Additionally, the difference between somatic or parietal pain and visceral pain will be explained to patients. Somatic or parietal pain arises from the outer layers of the body, such as the skin, muscles, and tissues. It is typically well-localized and sharp in nature, and increased with movement. In contrast, visceral pain originates from internal organs and is often described as dull, aching, or cramp-like that does not increase with movement. By understanding these distinctions, patients can better communicate their pain experiences.
Patient preparation:
The patients receive:
- Oral Famotidine 40 mg at night before the day of surgery.
- Ondansetron 4 mg IV immediately before surgery. Monitoring A multichannel monitor (Dräger, Vista 120) will be connected to the patient to display continuous electrocardiography monitoring for heart rate (beat/min) and detection of dysrhythmias, non-invasive arterial blood pressure (NIBP), pulse oxygen saturation (SpO2). Anaesthetic technique All patients undergoing elective CS surgery will receive spinal anaesthesia as the primary anaesthetic technique. Following the completion of the CS surgery, a Transversus Abdominis Plane (TAP) block will be performed to enhance postoperative pain management. Patient will be positioned supine on the operating table and the abdomen will be prepared and draped in a sterile manner to maintain aseptic conditions. Strict sterile techniques will be followed, including the use of sterile gloves, drapes, and local antiseptic solution for skin preparation. The ultrasound probe will be covered with a sterile sheath or barrier to ensure asepsis.
The TAP block will be performed using Sonosite M-turbo ultrasound with high-frequency (10-15 MHz) linear transducer. The skin will be disinfected with antiseptic solution. A linear transducer will be placed in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles will be visualized: external and internal oblique as well as the transversus abdominis muscles. The target is the fascial plane between the internal oblique and the transversus abdominis muscles. The needle will be inserted in the anterior axillary line, and the needle tip will be advanced until it reaches the fascial plane then 20 ml of 0.25% plain bupivacaine and 0.5 mg/kg ketamine will be injected in the first group and 50 microgram neostigmine in the second group under repeated aspiration for every 5 milliliters separating the plane between the internal oblique and transversus abdominis muscles with increased radiotranslucency approximately in the midaxillary line. The identical technique will be repeated on the opposite side.
Over the next 24 hours, all patients received 1 g of paracetamol IV every 8 hour as a part of multimodal analgesia. Measurements
The following parameters will be measured in every patient in the study:
- Vital signs Including heart rate (bpm), and mean arterial blood pressure (mmHg). All previous parameters will be continuously monitored and recorded before starting the surgery, intraoperatively and postoperatively after giving TAP block with adjuvants, at 2, 4, 6, 12, 18, and 24 hours postoperative.
- Pain scoring The visual analog scale (VAS) will be recorded intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively. The rescue analgesia (nalbuphine 6 mg IV) will be used when VAS score ≥ 4.
- Duration of analgesia (hours) Duration of analgesia defined as the time interval after start of the technique till the first need of rescue analgesic (nalbuphine 6 mg IV).
- Total dose of rescue analgesia (mg) Cumulative use of opioid (nalbuphine) in 24 hours.
- Patient satisfaction Patient satisfaction with the pain control will be assessed on a four-point scale as: Excellent, Good, Fair and Poor.
- Complications Any post-operative complication occurred at any time in the 24 hours of the study will be recorded and analyzed accordingly:
- Haemodynamic instability.
- Haematoma at the site of injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with Ketamine | Active comparator | Drug: TAP block with Ketamine40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side |
| TAP block with Neostigmine | Experimental | Drug: TAP block with neostigmine40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- ASA physical status I or II patients.
- Patients undergoing elective CS. Exclusion criteria
- Patients undergoing emergent CS.
- Patient refusal.
- Allergy to local anaesthesia or any additive drug.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TAP block with neostigmine40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side. | Drug | TAP block with Neostigmine |
| TAP block with Ketamine40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side. | Drug | TAP block with Ketamine |
Primary outcome
Post operative pain score
Time frame: Intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively
Change From Baseline in Pain Scores on the Visual Analog Scale
1 secondary outcome
Patient satisfaction
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 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAP block with neostigmine and TAP block with Ketamine in people with Caesarian Section and Postoperative Pain, run by Alexandria 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 9 inclusion and 0 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 11 Mar 2025. 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 phase mean?
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?
Post operative pain score (time frame: Intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively). 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 11 Mar 2025.