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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Egypt

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:

  1. 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.
  2. 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.
  3. 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).
  4. Total dose of rescue analgesia (mg) Cumulative use of opioid (nalbuphine) in 24 hours.
  5. Patient satisfaction Patient satisfaction with the pain control will be assessed on a four-point scale as: Excellent, Good, Fair and Poor.
  6. 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.
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 groups in NCT06871033
Study groupRoleWhat they receive
TAP block with KetamineActive comparator40 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 NeostigmineExperimental40 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.

  1. 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)
  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.

  1. First posted11 Mar 2025
  2. Study start1 Jan 2024
  3. Primary completion1 Dec 2024
  4. Study completion1 Jan 2025

Resources

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)
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

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.

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