Analgesic EfficacyNCT06584695
Analgesic Efficacy of External Oblique Intercostal Block vs Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy
A study testing Transversus abdominis plane block and External Oblique Intercostal Plane Block in people with Analgesic Efficacy and External Oblique Intercostal Block, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesic Efficacy, External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block
- What is being tested?
- Transversus abdominis plane block and External Oblique Intercostal Plane Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age (18-65) year.
- Both sexes.
- American Society of Anesthesiologists (ASA) class II and III.
- Cancer patients candidate for open nephrectomy .
Who cannot join
- Patient refusal.
- Skin lesions or infection at the site of proposed needle insertion.
- Cognitive disorders.
- History of psychiatric disorders or drug abuse.
- Patients allergic to medication used.
- ASA class IV.
- Coagulopathy.
- Body mass index (BMI) more than 35.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11796
Ahmed A Abdelbaset, Master, 00201144329865, ahmedabdelbaset500@gmail.com
Khaled Elsamahy, MD
About this study
Official title: Analgesic Efficacy of External Oblique Intercostal Block Versus Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy
To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.
Read the detailed description
Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.
Regional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.
Although abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.
Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.
The external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern
- Conditions
- Analgesic Efficacy, External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block, Open, Nephrectomy
- Being tested
- Transversus abdominis plane block, External Oblique Intercostal Plane Block, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockDrug
Patients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles along the subcostal line.
External Oblique Intercostal Plane BlockDrug
Patients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique with a 22G, 80 mm block needle will be used to inject 25 ml of 0.25% bupivacaine into the external oblique intercostal plane.
Control groupDrug
Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia.
General anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane group | Experimental | patients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block Receives: Drug: Transversus abdominis plane block |
| External oblique intercostal group | Experimental | Patients will receive unilateral ultrasound-guided external oblique intercostal block Receives: Drug: External Oblique Intercostal Plane Block |
| Control group | Active comparator | Patients will receive IV morphine 0.1mg/kg after induction of general anesthesia. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was > 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.
Measured: 24 hours after surgery
Secondary outcomes (6)
Mean arterial pressure
Mean arterial pressure will be recorded intraoperative till the end of surgery.
Measured: Till the end of surgery (up to 2hours)
Heart rate
Heart rate will be recorded intraoperative till the end of surgery.
Measured: Till the end of surgery (up to 2hours)
Opioids consumption
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). when the (NRS) was > 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.
Measured: 24 hours after surgery
Morphine consumption
When the numeric rating scale (NRS) was >4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.
Each patient will be instructed about postoperative pain assessment with the NRS score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable").NRS will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery.
Measured: 24 hours after surgery.
Time to rescue analgesia.
Time to rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Measured: 24 hours after surgery
Incidence of complications
Incidence of complications will be recorded such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start5 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic EfficacyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelbaset Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584695
- Sponsor's protocol ID
- AP2407-201-013
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of External Oblique Intercostal Block Versus Subcostal Transversus Abdominis Plane Block in Open Surgical Nephrectomy
- ClinicalTrials.gov ID
- NCT06584695
- Acronym / sponsor ID
- AP2407-201-013
- Conditions
- Analgesic Efficacy, External Oblique Intercostal Block, Subcostal Transversus Abdominis Plane Block, Open, Nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Sep 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.
To compare the efficacy of unilateral ultrasound-guided oblique subcostal transversus abdominis plane block with unilateral ultrasound-guided external oblique intercostal plane block in providing intraoperative and postoperative analgesia in cancer patients undergoing open nephrectomy.
Detailed description
Open surgery remains one of the procedures used for those patients requiring partial or radical nephrectomy and is associated with a high incidence of severe immediate postoperative pain and chronic pain the months following surgery.
Regional anesthesia techniques are frequently recommended for pain control in open nephrectomy as they decrease the need for parenteral opioid and improve patient satisfaction.
Although abdominal wall blocks are known to decrease opioid requirements without causing epidural associated hypotension, their role in flank surgeries has been less well-established. The dermatomes that need to be covered in flank incision are T9 to T11.
Studies have confirmed that ultrasound-guided (USG) transversus abdominis plane (TAP) block is an effective method of analgesia for upper abdominal surgeries, lower abdominal surgeries and kidney transplantation with minimal side effects.
The external oblique intercostal (EOI) block is a novel method providing simple and effective somatic analgesia to the upper abdomen with minimal side effects. Other advantages include easy sonoanatomy (even in obese patients), being performed in the supine position, and no anticoagulation concern
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane group | Experimental | Drug: Transversus abdominis plane blockpatients will receive unilateral ultrasound-guided oblique subcostal transversus abdominis plane block block |
| External oblique intercostal group | Experimental | Drug: External Oblique Intercostal Plane BlockPatients will receive unilateral ultrasound-guided external oblique intercostal block |
| Control group | Active comparator | Drug: Control groupPatients will receive IV morphine 0.1mg/kg after induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age (18-65) year.
- Both sexes.
- American Society of Anesthesiologists (ASA) class II and III.
- Cancer patients candidate for open nephrectomy .
Key exclusion criteria (8 listed)
- Patient refusal.
- Skin lesions or infection at the site of proposed needle insertion.
- Cognitive disorders.
- History of psychiatric disorders or drug abuse.
- Patients allergic to medication used.
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 blockPatients will receive transversus abdominis plane block with an oblique subcostal approach in the supine position. The anesthesiologist will place the linear ultrasound transducer obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The anesthesiologist will direct a 22G, 80 mm needle toward the transversus abdominis fascia and inject 25 mL of 0.25% bupivacaine between the rectus abdominis and transversus abdominis muscles along the subcostal line. | Drug | Transversus abdominis plane group |
| External Oblique Intercostal Plane BlockPatients will receive external oblique intercostal block the patient will be in the supine position with their ipsilateral arm abducted, A linear ultrasound transducer will be placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, with the orientation marker directed cranially. The skin will be sterilized, and the probe will be placed over the sixth rib medial to the anterior axillary line in a parasagittal orientation the in-plane technique with a 22G, 80 mm block needle will be used to inject 25 ml of 0.25% bupivacaine into the external oblique intercostal plane. | Drug | External oblique intercostal group |
| Control groupPatients will receive IV morphine 0.1mg/kg after induction of general anesthesia. General anesthesia induction will be performed with fentanyl 1-2 μg/kg, propofol 2-3 mg/kg, and rocuronium 0.6 mg/kg and maintained with sevoflurane. | Drug | Control group |
Primary outcome
Degree of pain
Time frame: 24 hours after surgery
Degree of pain by Numerical rating scale (NRS)score. NRS (0 pain represents "no pain" while 10 pain represents "the worst pain imaginable"). scores will be registered at rest and movement immediately after surgery and at two, six, 12 and 24 hours after surgery, when the (NRS) was > 4, IV morphine PCA will be initiated with continuous rate of 1 mg/hr, a patient demand bolus of 1mg and with lockout time of 10 minutes based on the patient weight and gender. the first time to the rescue analgesia needed and the top up doses will be recorded.
6 secondary outcomes
Mean arterial pressure
Time frame: Till the end of surgery (up to 2hours)
Heart rate
Time frame: Till the end of surgery (up to 2hours)
Opioids consumption
Time frame: 24 hours after surgery
Morphine consumption
Time frame: 24 hours after surgery.
Time to rescue analgesia.
Time frame: 24 hours after surgery
Incidence of complications
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Analgesic Efficacy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Not yet recruiting
Comparing Long-Acting Local Pain Relief Methods in PLIF Surgery
Posterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block and External Oblique Intercostal Plane Block in people with Analgesic Efficacy and External Oblique Intercostal Block, run by Cairo 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 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Abdelbaset, Master (00201144329865, ahmedabdelbaset500@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours after surgery). 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 19 Sep 2024.