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EOIPB in Laparoscopic Cholecystectomy: Impact on Opioid Consumption Guided by ANI and Analgesia Quality

Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06869837
Enrollment
80
Registered
2025-03-11
Start date
2025-04-08
Completion date
2025-12-20
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy Surgery, Pain Management

Keywords

external oblique intercostal plane block

Brief summary

The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.

Detailed description

Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.

Interventions

OTHERGroup EOİPB

Bilateral external oblique intercostal plane block under USG guidance will be applied 45 minutes before cholecystectomy surgery.

Sponsors

Samsun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Participants who will undergo elective laparoscopic cholecystectomy surgery, * Age 18-70, * ASA I-II physical status, * Body mass index (BMI) \< 35 kg/m², * Participants who have written consent to participate in the study

Exclusion criteria

* Participants with routine analgesic consumption, * Those with coagulopathy, * Those with a history of local anesthetic allergy, * Those with cardiac arrhythmia and pacemaker, * ASA III and above, Those with dementia

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative opioid consumptionDuring surgeryTotal amount of remifentanil consumed during cholecystectomy surgery

Secondary

MeasureTime frameDescription
Numeric rating scale for postoperative pain intensityup to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours)Evaluated with a Numerical rating scale (NRS) from 0 to 10. (0=no pain; 10=worst imaginable pain)
Quality of Recovery - 15 scorePostoperative 24th hourThe impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. Each question is scored between 0 and 10. The survey result varies between 0-150 points based on the answers given by the patients. Higher scores indicate better recovery.
Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)30 minutesEvaluated with a NRS from 0 to 10 and fentanyl will be administered when NRS is 4 and above. Fentanyl consumed will be recorded.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026