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

Z

Zagazig University

Status

Invitation-only

Conditions

Laparoscopic Cholecystectomy

Treatments

Procedure: US-guided RSB and TAPB by one-puncture technique.
Procedure: multipont

Study type

Interventional

Funder types

Other

Identifiers

NCT06599255
ZU-IRB#568/27-AUG-2024

Details and patient eligibility

About

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

Full description

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&

Enrollment

102 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

102 participants in 3 patient groups

one puncture
Active Comparator group
Description:
one-puncture technique of RSB combined with TAPB.
Treatment:
Procedure: US-guided RSB and TAPB by one-puncture technique.
Multipoint
Active Comparator group
Description:
multipoint technique of RSB combined with TAPB.
Treatment:
Procedure: multipont
control
No Intervention group
Description:
nalbuphine (2 mg/kg) and normal saline to a total volume of 150 mL, with a background infusion rate of 2 mL/h, a bolus dose of 2 mL, a lockout interval of 15 min, and a maximum limit of 10 mL within 1 h.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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