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Not yet recruitingNCT06810206Updated Aug 20, 2026

A Comparison Between The Efficacy of Modified Thoracoabdominal Plane Block Via Perichondral Approach (M-TAPA) And External Oblique Intercostal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy Surgeries (LC)

An interventional study of Bilateral Ultrasound Guidance M-TAPA and Bilateral Ultrasound Guidance EOIPB in Post Operative Pain, sponsored by Kasr El Aini Hospital. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

Because laparoscopic procedures have a number of benefits over open procedures, they have completely changed the surgical industry.(1) Laparoscopic cholecystectomy (LC) is a minimally invasive technique that usually yields less discomfort following surgery, shorter hospital stays, and quicker patient recovery, plus it's an economical operation. Nevertheless, it results in moderate to severe pain.(2).By using regional anesthesia techniques to effectively control pain and lessen the requirement for opioid analgesics, ERAS implementation has demonstrated significant decreases in opioid usage and improved overall patient outcomes (3). (4) To minimize the need for opioids, opioid sparing anesthesia employs a multimodal strategy that includes nonsteroidal anti-inflammatory medications, paracetamol, local anesthetics (LA), and, if feasible, regional anesthetic techniques and regional analgesia. (5) With fewer systemic side effects, regional anesthetic techniques-like nerve blocks-offer tailored pain treatment. The best regional pain management strategy for LC surgery is still unknown, though.(4) Modified Thoracoabdominal Nerves Block Through Perichondral Approach (M-TAPA) Block is a new technique defined as a modification of TAPA Block in which local anaesthetics are administered only to the underside of the perichondral surface, creating a sensory block between T5-T12 dermatomes. While the external oblique intercostal plane (EOIPB) block provides blockade of the lateral and anterior cutaneous branches of the intercostal nerves from T6/7 to T10/11.This study aims to compare the efficacy of both MTAPA and EOIPB in patients undergoing LC surgery .

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Conditions studied

  • Post Operative Pain

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Keywords

  • postoperative pain
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In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-65 years
  • Scheduled for Laparoscopic cholecystectomy surgery
  • ASA (American Society of Anaesthesiologists) physical status I-II

Exclusion criteria

Exclusion Criteria:

  • Known allergy to local anaesthetics
  • Coagulopathy or anticoagulant use
  • Infection at the site of block
  • Chronic pain conditions
  • Advanced liver or kidney failure
  • History of abdominal surgery or trauma
  • Alcohol or drug use
  • Refusal to participate
  • Chronic opioid consumption
  • Use of painkillers in the preoperative 24hours
  • Conversion to open surgery
  • ( BMI ) > 35
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A

    Group A: 30 patients will receive the MTAPA.

    Other: Bilateral Ultrasound Guidance M-TAPA

  • Active comparator
    Group B

    Group B: 30 patients will receive the EOIPB.

    Procedure: Bilateral Ultrasound Guidance EOIPB

Interventions

  • OtherBilateral Ultrasound Guidance M-TAPA

    transversus abdominis, internal oblique, and external oblique muscles will be identified on the costochondral angle in the sagittal plane at the 10th costal margin. deep angle will be given to the costochondral angle at the edge of the 10th costa with the probe in the sagittal direction to view the lower surface of the costal cartilage in the midline. The needle will be inserted in the cranial direction using the in-plane technique, and the needle tip will be moved to the posterior aspect of the 10th costal cartilage, and saline (5 ml) will be injected to confirm the location by observing dissection between internal oblique muscle and transversus abdominis muscle under the 10th costal cartilage, and local anesthetic will be injected into the lower surface of the chondrium. The local anesthetic to be used is bupivacaine 0.25% with Ultrasound Siemens® ACUSON X300 portable scanner with a high frequency linear transducer (10 MHz) using A Quincke 22 G . x 3½ in. (0.7x88 mm) A spinal needle

    Also known as: Modified throacoabdominal plane block (M-TAPA), GROUP A

  • ProcedureBilateral Ultrasound Guidance EOIPB

    The patients will be positioned in the supine position with the ipsilateral arm in abduction. The transducer will be positioned in a cephalad to caudad parasagittal plane at the anterior axillary line at the level of the sixth and seventh ribs in line with the xiphoid process. Using the in-plane technique, the needle will be advanced from cephalad to caudad until the tip lies in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs. Following hydro-dissection with 2 ml of 0.9% saline to confirm the correct needle tip position, LA injection will be given. The same procedure will then be repeated on the contralateral * Local anesthetics to be injected: iBupivacaine (0.25%) * Dose : 25ml on each side * Device to be used: Ultrasound Siemens® ACUSON X300 portable scanner with a high-frequency linear transducer (10 MHz) that is covered in sterile plastic. * Needle to be used : A Quincke 22 G . x 3½ inch (0.7x88 mm) spinal needle

    Also known as: External Oblique Intercoastal Plane Block ( EOIPB ), GROUP B

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What researchers measure

Primary outcomes

  1. comparing the effectiveness of the modified thoracoabdominal plane block via perichondral approach versus the external oblique intercoastal plane block in reducing pain in laparoscopic cholecystectomy surgery's patients through calculating the mean NRS

    Numerical Rating Score (NRS) for Pain severity will be measured with a NRS of 0, being no pain , while of 10 being worst pain imaginable. NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period. (11) Patients will be educated and familiarized with NRS scores in the preoperative period. Postoperative, pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV /6hours, Ketorolac 30mg IV /8hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still \> 4 , additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose , can be repeated up to four times per day with maximum dose of 80 mg per day (18)

    Time frame: . NRS scores will be recorded postoperatively upon arrival to PACU and it will be noted as point (0) and then at 20 minutes , and then after the 1st hour , and the at the 6th hour , 12 th hour and 24th hour for a total of 24-hour period.

Secondary outcomes

  1. evaluating the quality of recovery via the QOR-40 questionnaire.

    To evaluate the quality of recovery, the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU. Scores range from a minimum of 40 (poor recovery) to a maximum of 200 (excellent recovery).

    Time frame: the Quality of Recovery-40 (QoR-40) questionnaire will be used in PACU after 10 minutes from patient arrival to the PACU .

  2. identifying dermatomal coverage of each block via pinprick test.

    Dermatomal coverage will be tested using pinprick test to evaluate the T3-L1 sensory levels in PACU after evaluating the QoR-40 ( since block will be administered after induction of anaesthesia ) . Anterior and lateral cutaneous branches will be evaluated on a vertical line 3-5 cm from the midline and midaxillary lines, respectively. A 3-point numerical scale (0 = no pain, 1 = decreasing pain, 2 = normal pain) will be used. The values of 0 or 1 will be defined as effective . The normal sense in the shoulder will be used for comparison. (11,17)

    Time frame: Dermatomal coverage will be tested using pinprick test in PACU after evaluating the QoR-40 within the first hour postoperatively

  3. evaluating the efficacy of each block in providing analgesia intraoperatively by measuring amount of fentanyl consumed in micrograms

    * Anaesthesia induction and endotracheal intubation will be performed after preoxygenation with 100% oxygen, intravenously using propofol 2 mg/kg, fentanyl 1-2 µg/kg, and atracurium 0.5 mg/kg. Anaesthesia will be maintained with isoflurane (0.8-1.2 MAC) and atracurium 0.1mg/kg/20 mins * additional boluses of fentanyl IV dose of 0.25 micrograms/kg/dose will be given if blood pressure and/or heart rate increase by 20% of baseline, with calculation of total fentanyl consumption intraoperatively in micrograms

    Time frame: intraoperatively

  4. Total opioid consumption in the first 24 hours postoperatively in mgs

    * Total Nalbuphine consumption will be recorded in mgs for a total of 24-hour period * Postoperative pain control regimen will be used for the two groups as Paracetamol 15mg/kg IV / 6 hours, Ketorolac 30 mg IV/8 hours. If the patient's NRS pain score happens to be ≥ 4 points, 10 mg of intravenous nalbuphine Will be given , and the NRS will be repeated again after 15 minutes , if still \> 4; additional 10 mg IV nalbuphine will be given , with maximum dose of 20 mg per dose that can be repeated up to four times per day with maximum dose of 80 mg per day

    Time frame: postoperatively with a total of 24 hour

  5. Time to first mobilization in hours

    ●The time to mobilization of the patients following surgery will be recorded in hours Mobilization will be defined as being able to at least sit on the edge of the bed.

    Time frame: postoperatively up to 24 hour

  6. Incidence of block-related complications

    Incidence of block-related complications (e.g., hematoma, infection, nerve damage , LAST )

    Time frame: postoperatively with a total of 24 hour

  7. Incidence of PONV.

    ●Verbal descriptive scale for Postoperative Nausea and Vomiting (PONV) will be used with 0 = none , 1 = mild nausea , 2= moderate nausea , 3= vomiting once , 4= multiple vomiting .

    Time frame: every six hours for a total of 24 hour postoperatively

  8. the Time to first rescue opioid

    the time to first rescue opioid will be noted and defined as the duration in hours that the patient lasted without the need of nalbuphine IV dose of 10 mg (NRS\<4).

    Time frame: it will be measured postoperatively for a total period of 24 hour

  9. time taken to adminsiter the block bilaterally

    The time required to perform each bilateral block was recorded in minutes, beginning immediately after completion of skin sterilization and from the start of puncture to the end of LA infusion and ending upon completion of the bilateral local anesthetic injections.201 Block performance time was compared between the M-TAPA and EOIPB groups as an indicator of procedural feasibility and technical ease. In addition, the relationship between block performance time and patient BMI was evaluated to determine whether either technique is less affected by increasing BMI, thereby providing evidence regarding its ease of implementation in patients with higher body mass.

    Time frame: just after induction of anestheisa intraoperative

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Study locations

1 site
  • Faculity of medicine , Kasr Al Aini Hospitals , Cairo University
    Cairo, Egypt
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References and documents

Publications

  • Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4. PubMed 36307755 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06810206
Responsible party
Miran Mohamed Abdelmagyd (Doctor, Kasr El Aini Hospital) — Principal investigator
First posted
Feb 5, 2025
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Miran M Abdelaziz Raslan, MSC
Contact
miranrs1994@gmail.com
00201140646969
Nora A Agiza, MD
Contact
noraagiza@gmail.com
00201001881060

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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