Menu
Not yet recruiting NCT07384000

Comparison Between External Oblique Intercostal Plane Block and Rectus Sheath Block Combined With Transversus Abdominis Plane Block

No phase Interventional Pain Management Anesthesia , Analgesia Nerve Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: External intercostal plane puncture, control group (nalbuphine), the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block).
Who it may be relevant to
Registry conditions: Pain Management, Anesthesia , Analgesia, Nerve Block. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Efficacy of Single Puncture Technique of Rectus Sheath Block Combined With Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Pain Control After Laparoscopic Cholecystectomy.

Overview

Effective perioperative pain management remains a cornerstone in enhancing recovery and improving patient outcomes in laparoscopic cholecystectomy. This minimally invasive procedure, although less traumatic compared to open surgery, can still lead to significant postoperative pain, particularly in the early hours following the operation. Insufficient pain control may result in delayed mobilization, prolonged hospital stays, and increased opioid consumption, which are associated with adverse side effects and a heightened risk of complications . Regional anesthesia techniques have garnered significant attention for their ability to provide localized, opioid-sparing analgesia, thereby improving postoperative recovery profiles.External Oblique Intercostal Plane Block (EOIP) is a relatively new regional anesthesia technique targeting the intercostal nerves (T7-T11) as they traverse the plane between the external and internal oblique muscles. This block has demonstrated efficacy in controlling postoperative pain for upper abdominal surgeries, including laparoscopic cholecystectomy. By selectively anesthetizing the sensory branches of the thoracoabdominal nerves, the EOIP block provides localized analgesia with minimal motor blockade, making it an ideal choice for early mobilization (Ouchi et al., 2020).Recent advancements in ultrasound-guided techniques have improved the precision and safety of the EOIP block, allowing for consistent blockade of the targeted nerves. Clinical trials have highlighted its ability to reduce the pain significantly in the first 24 hours postoperatively, along with a marked decrease in the need for rescue analgesics. Tranrversus abdominis plane block (TAP) , first described in the early 2000s, has undergone several modifications to improve its efficacy in abdominal surgeries. The subcostal TAP block targets the anterior branches of the lower thoracic nerves (T6-T9) to provide analgesia to the upper abdominal wall. This technique is particularly suited for laparoscopic cholecystectomy, where the pain originates predominantly from the pari0etal peritoneum and abdominal wall incisions.The single puncture technique of Rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) represents a more streamlined approach to abdominal wall analgesia. ultrasonography (US) guidance for peripheral nerve blocks has become more and more popular. Transversus abdominis plane block (TAPB) and US-guided rectus sheath block (RSB) have been utilized in abdominal surgeries and have shown strong analgesic effects. Prior researches has demonstrated that in abdominal surgery, US-guided (TAPB) in conjunction with (RSB) had superior analgesic effects than either (TAPB) or (RSB) alone. Currently, multipoint nerve block procedures are generally applied in clinical practice, but they are difficult and can increase the patient's suffering. A novel method is proposed based on the neuromuscular anatomy and the location of the incisiopn in laparoscopic upper abdominal surgery: US-guided transverse abdominis plane and rectus sheath block one-puncture .

Detailed description

This study aims to investigate the analgesic efficacy of external oblique intercostal plane (EOIPB) versus single puncture technique of rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) after laparoscopic cholecystectomy.

Primary Outcome:

The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.

Secondary Outcomes:

the analgesic efficacy (Sensory assessment) by defined dermal zones in the first 24 hours postoperatively.

pain intensity at rest and during coughing using verbal rating scale in the first 24 hours postoperatively.

Patient satisfaction in the first 24 hours postoperatively. The hemodynamic changes. Time to first rescue analgesia. First off-bed activity Incidence of block-related complications. Signs of local anesthetic toxicity hypotension ,bradycardia ,tachyarrhythmia, postoperative nausea and vomiting (PONV) and dizziness.

Interventions

  • Procedure External intercostal plane puncture
    Patients in this group will receive external intercostal plane block bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side.
  • Drug control group (nalbuphine)
    Patients in this group will not receive any intervention or nerve block.
  • Procedure the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)
    Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior

Primary outcome measures

  • Decrase the consumption of opioids [Time frame: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative]
Secondary outcome measures (3)
  • The analgesic efficacy (sensory assessment) [Time frame: First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively]
  • Pain intensity [Time frame: Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative]
  • Off bed activity [Time frame: 24 hours postoperative]

Eligibility criteria

Inclusion criteria

  • Patients undergoing elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) 1-II
  • aged 18-70 years
  • both genders will be included.
  • body mass index (BMI) ≤ 35 kg/m2.

Exclusion criteria

  • coagulation disorders
  • liver/kidney disease
  • History of abdominal surgery
  • infection in the block application area
  • chronic opioid use
  • local anesthetic (LA) allergy
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Yu S, Wen Y, Lin J, Yang J, He Y, Zuo Y. Combined rectus sheath block with transverse abdominis plane block by one puncture for analgesia after laparoscopic upper abdominal surgery: a randomized controlled prospective study. BMC Anesthesiol. 2024 Feb 9;24(1):58. doi: 10.1186/s12871-024-02444-6. PMID 38336613

Identifiers

NCT: NCT07384000 · nerve block in pain management

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗