AnalgesiaPhase 1TFBPNCT06935669
Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block
A Phase 1 study testing Ketamine, Bupivacaine and Bupivacain in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Ketamine, Bupivacaine and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2025to 15 May 2026
- Phase
- Phase 1
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aging ≥ 21 years to ≤ 45.
- Patients undergoing cesarean section under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical statusphysical status classes II.
Who cannot join
- Patient's refusal of procedure or participation in the study.
- Coagulopathy and bleeding disorders.
- Use of chronic pain medications.
- Pregnancy-induced hypertension or diabetes.
- Evidence of Local skin infections at site of injection.
- Body mass index >40kg/m2
- A history of relevant local anesthetic allergy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eman Sh Abdelmaqsoud contact
Egypt1 site
Ain Shams University faculty of medicine
Cairo, Egypt
Ain Shams University faculty of medicine Ain Shams Universit faculty of medicine, 02 26837673, dr.ahmedadel1999@gmail.com
About this study
Official title: Randomised Controlled Clinical Trial Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block After Cesarean Section Under Spinal Anaesthesia
The objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia.
Read the detailed description
Cesarean section (CS) is one of the most common surgeries and usually causes moderate to severe pain for up to 48 h. The rate of CS, which is a life-saving surgical procedure in cases of certain complications that occur during pregnancy and birth, has exceeded 20% worldwide Pain control after CS has crucial importance, especially in the first 24 h, to facilitate early ambulation and the establishment of breastfeeding. Insufficient analgesia in the postoperative period may cause a number of undesirable effects, such as patient discomfort, thromboembolism due to extended immobilization, and increased pulmonary secretions resulting in complications The well-known side effects of analgesic morphine as nausea, vomiting, itching and sedation, may interfere with the interaction between mother and child, breastfeeding and post-partum experience in a dose-dependent manner. However, a number of alternative strategies have been described in order to reduce morphine consumption post-operatively .
The mode and type of analgesia should be safe and effective. A stimulus caused by a lesion in tissue or organs during surgery is the cause of postoperative pain .
The primary source of pain after abdominal surgeries, including CS, are the anterior abdominal wall and abdominal viscera, and blocking these areas could provide proper postoperative analgesia .
Recently, the application of fascial plane blocks has increased due to the widespread use of ultrasound among anesthesiologists and the avoidance of opioids in a multimodal analgesic strategy. Different regional anesthetic techniques have been introduced, including ilioinguinal nerve blocks, abdominal field blocks, Transversalis Fascia Plane (TFP) blocks, and Transversus Abdominis Plane (TAP) blocks to alleviate pain from the abdominal wall incision .
Transversalis Fascia Plane, performed in the posterior axillary line, blocks branches of L1 nerve roots, including ilioinguinal and iliohypogastric nerves. This method has been used to control postoperative pain in patients undergoing different lower abdominal surgeries A variety of anesthetic agents such as bupivacaine, levobupivacaine, and ropivacaine are commonly used in TAP blocks. These drugs provide short-term analgesia and primarily alleviate somatic pain. To extend the duration of analgesic efficacy, various adjuvants such as opioids, ketamine, clonidine, and alpha-2 agonists like dexmedetomidine have been added .
Bupivacaine is one of the widely used local analgesics. ketamine affects pain modulation through multiple mechanisms of action. It is a non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist, which exerts an anti-hyperalgesic effect by decreasing central sensitization and reducing the wind-up phenomenon in the postoperative period .
The aim of this study is to investigate the effect of transversalis fascia plane block using bupivacaine plus ketamine on postoperative pain compared to bupivacaine alone in patients undergoing cesarean section under spinal anaesthesia.
- Conditions
- Analgesia
- Being tested
- Ketamine, Bupivacaine, Bupivacain
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.
BupivacaineDrug
Also called Marcaine
Control group to evaluate the additional effect of ketamine in the experimental arm.
BupivacainDrug
Also called Marcaine
Patients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine and bupivacaine | Experimental | Transversalis fascia plane block Receives: Drug: Ketamine; Drug: Bupivacain |
| Bupivacaine alone | Active comparator | Transversalis fascia plane block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean VAS pain on movement will be recorded as the primary outcome of the study
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain.
Patients will report their pain levels at rest and during movement at 24 hours after the transversalis fascia plane block.
The mean VAS score will be compared between the ketamine + bupivacaine group and the bupivacaine-only group.
Measured: day 1
Secondary outcomes (2)
Time to first rescue analgesia will be recorded
Time (in minutes/hours) from the completion of the transversalis fascia plane block to the administration of the first dose of rescue analgesia will be recorded.
Rescue analgesia will be given when the patient reports a VAS score ≥ 4 or requests additional pain relief.
A longer time to first rescue analgesia in the ketamine + bupivacaine group would indicate prolonged analgesic duration compared to the bupivacaine-only group.
Measured: Day 1
total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded
Rescue analgesia will be given when the patient reports a VAS score ≥ 4 or requests additional pain relief.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AHMED Ad Elgamal, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935669
- Sponsor's protocol ID
- FMASU MD36/2025
- Acronym
- TFBP
- Status last verified
- Mar 2025
- First submitted
- 4 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan, Shamsul Kamaruljan, et al. "Comparison of analgesic efficacy and safety of bupivacaine plus ketamine versus bupivacaine alone in rectus sheath block for midline laparotomy." Anaesthesia, Pain & Intensive Care 27.2 (2023): 154-160.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block After Cesarean Section Under Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT06935669
- Acronym / sponsor ID
- TFBP / FMASU MD36/2025
- Conditions
- Analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 20 Apr 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 objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia.
Detailed description
Cesarean section (CS) is one of the most common surgeries and usually causes moderate to severe pain for up to 48 h. The rate of CS, which is a life-saving surgical procedure in cases of certain complications that occur during pregnancy and birth, has exceeded 20% worldwide Pain control after CS has crucial importance, especially in the first 24 h, to facilitate early ambulation and the establishment of breastfeeding. Insufficient analgesia in the postoperative period may cause a number of undesirable effects, such as patient discomfort, thromboembolism due to extended immobilization, and increased pulmonary secretions resulting in complications The well-known side effects of analgesic morphine as nausea, vomiting, itching and sedation, may interfere with the interaction between mother and child, breastfeeding and post-partum experience in a dose-dependent manner. However, a number of alternative strategies have been described in order to reduce morphine consumption post-operatively .
The mode and type of analgesia should be safe and effective. A stimulus caused by a lesion in tissue or organs during surgery is the cause of postoperative pain .
The primary source of pain after abdominal surgeries, including CS, are the anterior abdominal wall and abdominal viscera, and blocking these areas could provide proper postoperative analgesia .
Recently, the application of fascial plane blocks has increased due to the widespread use of ultrasound among anesthesiologists and the avoidance of opioids in a multimodal analgesic strategy. Different regional anesthetic techniques have been introduced, including ilioinguinal nerve blocks, abdominal field blocks, Transversalis Fascia Plane (TFP) blocks, and Transversus Abdominis Plane (TAP) blocks to alleviate pain from the abdominal wall incision .
Transversalis Fascia Plane, performed in the posterior axillary line, blocks branches of L1 nerve roots, including ilioinguinal and iliohypogastric nerves. This method has been used to control postoperative pain in patients undergoing different lower abdominal surgeries A variety of anesthetic agents such as bupivacaine, levobupivacaine, and ropivacaine are commonly used in TAP blocks. These drugs provide short-term analgesia and primarily alleviate somatic pain. To extend the duration of analgesic efficacy, various adjuvants such as opioids, ketamine, clonidine, and alpha-2 agonists like dexmedetomidine have been added .
Bupivacaine is one of the widely used local analgesics. ketamine affects pain modulation through multiple mechanisms of action. It is a non-competitive N-methyl-d-aspartate (NMDA) receptor antagonist, which exerts an anti-hyperalgesic effect by decreasing central sensitization and reducing the wind-up phenomenon in the postoperative period .
The aim of this study is to investigate the effect of transversalis fascia plane block using bupivacaine plus ketamine on postoperative pain compared to bupivacaine alone in patients undergoing cesarean section under spinal anaesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine and bupivacaine | Experimental | Drug: Ketamine, Drug: BupivacainTransversalis fascia plane block |
| Bupivacaine alone | Active comparator | Drug: BupivacaineTransversalis fascia plane block |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aging ≥ 21 years to ≤ 45.
- Patients undergoing cesarean section under spinal anesthesia.
- American Society of Anesthesiologists (ASA) physical statusphysical status classes II.
Key exclusion criteria (7 listed)
- Patient's refusal of procedure or participation in the study.
- Coagulopathy and bleeding disorders.
- Use of chronic pain medications.
- Pregnancy-induced hypertension or diabetes.
- Evidence of Local skin infections at site of injection.
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 |
|---|---|---|
| KetamineAlso: KetalarPatients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine. | Drug | Ketamine and bupivacaine |
| BupivacaineAlso: MarcaineControl group to evaluate the additional effect of ketamine in the experimental arm. | Drug | Bupivacaine alone |
| BupivacainAlso: MarcainePatients in this group will receive a transversalis fascia plane block using a combination of bupivacaine and ketamine. | Drug | Ketamine and bupivacaine |
Primary outcome
The mean VAS pain on movement will be recorded as the primary outcome of the study
Time frame: day 1
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain. Patients will report their pain levels at rest and during movement at 24 hours after the transversalis fascia plane block. The mean VAS score will be compared between the ketamine + bupivacaine group and the bupivacaine-only group.
2 secondary outcomes
Time to first rescue analgesia will be recorded
Time frame: Day 1
total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded
Time frame: Day 1
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 20 Apr 2025.
- Results publicationHassan, Shamsul Kamaruljan, et al. "Comparison of analgesic efficacy and safety of bupivacaine plus ketamine versus bupivacaine alone in rectus sheath block for midline laparotomy." Anaesthesia, Pain & Intensive Care 27.2 (2023): 154-160.
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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.
Eman Sh Abdelmaqsoud contact
AHMED Ad Elgamal principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine, Bupivacaine and Bupivacain in people with Analgesia, run by Ain Shams 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 3 inclusion and 7 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 20 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed Ad MAHMOUD Ebrahim elgamal (+02 01159008254, AhmedElgamal@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean VAS pain on movement will be recorded as the primary outcome of the study (time frame: day 1). 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 NCT06935669, which also lists 1 linked publication.
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 20 Apr 2025.