NCT07384000

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

January 11, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Decrase the consumption of opioids

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

    Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative

Secondary Outcomes (3)

  • The analgesic efficacy (sensory assessment)

    First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively

  • Pain intensity

    Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative

  • Off bed activity

    24 hours postoperative

Study Arms (3)

external intercostal plane block intervention with ultra sound

ACTIVE COMPARATOR

Patients in this group will receive (EOIPB) 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.

Procedure: External intercostal plane puncture

single-puncture technique of (RSB) combined with (TAPB) by ultra sound

ACTIVE COMPARATOR

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 layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .

Procedure: the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block)

control group (nalbuphine)

PLACEBO COMPARATOR

Patients in this group will not receive any intervention or nerve block.

Drug: control group (nalbuphine)

Interventions

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.

external intercostal plane block intervention with ultra sound

Patients in this group will not receive any intervention or nerve block.

control group (nalbuphine)

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 layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .

single-puncture technique of (RSB) combined with (TAPB) by ultra sound

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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; PMCID: PMC10854179.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Agnosia

Interventions

Control GroupsNalbuphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Osama Mohamed, Master degree

CONTACT

Menna Tallah Mamdouh Lecturer, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in parallel to one of three groups: (1) external intercostal plane block, or (2) combined rectus sheath block and transversus abdominis plane block by single puncture technique (3) the control group recieve nalbuphine . Each participant receives only one intervention according to group allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2026

First Posted

February 3, 2026

Study Start

January 20, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 3, 2026

Record last verified: 2025-12