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Enrolling by Invitation

NCT Number: NCT06599255

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block

the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique

Enrolling by Invitation

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine,Zagazig University

Zagazig, Elsharkia,, Egypt,, 44519, Egypt

About this study

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture "O" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.

In the Multipoint "M " group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.

In the Control "C " group (n=34 ): The patient will receive patient controlled analgesia&;PCA&

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-45 years old.
  • Sex: both sexes.
  • Physical status: ASA I to III.
  • Body mass index (BMI): 18- 30 kg/m2.
  • Type of operations: elective laparoscopic cholecystectomy.
  • Written informed consent from the patient.

Exclusion criteria

  • Known hypersensitivity to lidocaine or bupivacaine.
  • Opioid-dependent patients.
  • Coagulation disorders or taking drugs affect surgical hemostasis.
  • Patients with pre-existing neurological deficits.
  • Uncooperative patient or with altered mental status.

Treatment and study plan

US-guided RSB and TAPB by one-puncture technique.

Procedure

The probe will be positioned transversely in the midline of the abdomen, between the xiphoid process and the umbilicus, revealing the linea alba. It was then moved outward along the costal margin, demonstrating the rectus abdominis overlapping the transverse abdominis. A 22-gauge, 120-mm ultrasound-visible block needle will be inserted from the inner side . Under direct vision, we will reach the posterior rectus abdominis sheath and pierced the anterior layer of the posterior sheath. Saline was injected to adjust its position. After that, 15 mL of 0.25% bupivacaine will be administered (aspiration was performed for every 5 mL injection), and we will observe the local anesthetic spreading inward . Then, the needle will break through the posterior layer of the tendon, and saline will be injected to confirm the needle's placement in the transversus abdominis plane. After confirming the tip placement, 15 mL of 0.25% bupivacaine will be slowly injected. The needle tip will be advanced al

multipont

Procedure

, the probe will be moved outward along the costal margin until the external oblique muscle, internal oblique muscle, and transverse abdominis muscle will be visible [9]. The needle will be inserted in-plane until the tip was positioned in the plane between the internal oblique muscle and the transverse abdominis muscle. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution.

For the RSB, the same technique will be done as one puncture technique. Then, 15 mL of 0.25% bupivacaine will be injected . The contralateral nerve block will be performed using the same method and volume of anesthetic solution.

Primary outcomes

  1. The total postoperative opioid consumption in the first 24 hours.

    Time frame: 24 hours postoperative

    opioid consumption

Secondary outcomes

  1. The block performance time

    Time frame: up to 5 minutes

    the time from the placement of the ultrasound probe on the patient's skin to the end of the local anesthetic injection

  2. Onset of sensory block

    Time frame: up to 30 minutes

    the time from the end of the injection of local anesthetic (bupivacaine) to the loss of pinprick sensation using a sterile 25-G needle in the operation field.

  3. The Numerical Pain Rating Scale

    Time frame: 24 hours postoperative

    A ten-centimeter Numerical Pain Rating Scale (0 - no pain and 10 - worst pain)

  4. Patient satisfaction

    Time frame: 24 hour postoperative

    The patient satisfactionwill be assessed using the 7-point Likert-like verbal rating scale The patientwill be asked to express his satisfaction

    • extremely dissatisfied.
    • Dissatisfied.
    • somewhat dissatisfied.
    • unsatisfied.
    • somewhat satisfied.
    • Satisfied.
    • extremely satisfied.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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