Regional Analgesia Techniques for Laparoscopic Cholecystectomy

NCT07241949 | Not Yet Recruiting

• 1 other identifier: Pending-EC-2025-NSadikoglu
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, randomized controlled trial aims to compare the effects of paravertebral block (PVB), external oblique intercostal (EOI) block, and intravenous patient-controlled analgesia (PCA) with tramadol on postoperative pain and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint is total tramadol consumption within 24 hours postoperatively. Secondary outcomes include pain scores, additional analgesic use, incidence of nausea/vomiting, mobilization time, and length of hospital stay.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy; Paravertebral Block; External Oblique Intercostal Plane Block; Patient Controlled Analgesia

Keywords

Cholecystectomy; Pain; Analgesia; Tramadol; Nerve Block

Outcome Measures

Primary Outcomes (1)

• 24-hour postoperative tramadol consumption

  Total amount of intravenous tramadol administered via PCA within the first 24 hours after surgery.

  Within the first 24 hours after surgery.

Secondary Outcomes (4)

• Postoperative pain scores at rest

  1, 6, 12, and 24 hours postoperatively

• Incidence of postoperative nausea and vomiting

  Within 24 hours postoperatively

• Incidence of block-related complications

  Intraoperative and first 24 hours after block

• Patient satisfaction with analgesia

  24 hours postoperatively

Study Arms (3)

Paravertebral Block Group

ACTIVE COMPARATOR

Participants in this arm will receive bilateral paravertebral block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be administered to provide postoperative analgesia following laparoscopic cholecystectomy. Patients will also receive standard intravenous paracetamol postoperatively.

Procedure: Paravertebral Block (PVB)

External Oblique Intercostal Block Group

ACTIVE COMPARATOR

Participants in this arm will receive bilateral external oblique intercostal (EOI) block after induction of general anesthesia. Under ultrasound guidance, 0.25% bupivacaine (20 mL per side; total 40 mL) will be injected into the fascial plane between the external oblique and intercostal muscles. Standard intravenous paracetamol will be administered postoperatively.

Procedure: External Oblique Intercostal Block (EOI Block)

Control Group - IV PCA Tramadol

ACTIVE COMPARATOR

Participants in this arm will receive intravenous patient-controlled analgesia (PCA) with tramadol for postoperative pain management. The PCA pump will be set to a maximum dose of 400 mg tramadol in 24 hours. Standard intravenous paracetamol (1 g every 8 hours) will also be administered. No regional anesthesia block will be performed in this group.

Drug: Tramadol IV Patient-Controlled Analgesia (PCA)

Interventions

Paravertebral Block (PVB) PROCEDURE

Ultrasound-guided bilateral thoracic paravertebral block performed after induction of general anesthesia using 0.25% bupivacaine, 20 mL per side (total 40 mL).

Paravertebral Block Group

External Oblique Intercostal Block (EOI Block) PROCEDURE

Ultrasound-guided bilateral external oblique intercostal block performed after induction of general anesthesia with 0.25% bupivacaine, 20 mL per side (total 40 mL), injected between the external oblique and intercostal muscles.

External Oblique Intercostal Block Group

Tramadol IV Patient-Controlled Analgesia (PCA) DRUG

Intravenous patient-controlled analgesia (PCA) programmed to deliver tramadol with a maximum dose of 400 mg in 24 hours. Standard analgesia protocol includes IV paracetamol 1 g every 8 hours.

Also known as: Control group

Control Group - IV PCA Tramadol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Scheduled for elective laparoscopic cholecystectomy under general anesthesia
• ASA physical status I-III
• Able to understand the study procedure and provide informed consent

You may not qualify if:

• Patient refusal or inability to provide informed consent
• Allergy or contraindication to local anesthetics, tramadol, or study medications
• Coagulopathy or current anticoagulant therapy
• Local infection at the planned block injection site
• Severe hepatic or renal impairment
• Chronic opioid use or opioid dependence
• Neurological or psychiatric disorders affecting pain perception or communication
• Pregnancy or breastfeeding
• Body mass index (BMI) \> 35 kg/m²
• Conversion to open cholecystectomy during surgery

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Medicine

Adana, Turkey (Türkiye)

Location

Related Publications (10)

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Erskine RN, White L. "A review of the external oblique intercostal plane block - a novel approach to analgesia for upper abdominal surgery". J Clin Anesth. 2022 Nov;82:110953. doi: 10.1016/j.jclinane.2022.110953. Epub 2022 Aug 19. No abstract available.

  PMID: 35994942 BACKGROUND

• Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.

  PMID: 30635518 BACKGROUND

• Hamilton DL, Manickam BP. Is a Thoracic Fascial Plane Block the Answer to Upper Abdominal Wall Analgesia? Reg Anesth Pain Med. 2018 Nov;43(8):891-892. doi: 10.1097/AAP.0000000000000838. No abstract available.

  PMID: 30339615 BACKGROUND

• Kus A, Gurkan Y, Arslan ZI, Akgul AG, Aksu C, Toker K, Solak M. [Our ultrasound-guided paravertebral block experiences in thoracic surgery]. Agri. 2015;27(3):139-42. doi: 10.5505/agri.2015.59885. Turkish.

  PMID: 26356102 BACKGROUND

• Barazanchi AWH, MacFater WS, Rahiri JL, Tutone S, Hill AG, Joshi GP; PROSPECT collaboration. Evidence-based management of pain after laparoscopic cholecystectomy: a PROSPECT review update. Br J Anaesth. 2018 Oct;121(4):787-803. doi: 10.1016/j.bja.2018.06.023. Epub 2018 Aug 7.

  PMID: 30236241 BACKGROUND

• O'Donovan B, Martin B. The Novel Use of an External Oblique Nerve Catheter After Open Cholecystectomy. Cureus. 2021 Feb 26;13(2):e13580. doi: 10.7759/cureus.13580.

  PMID: 33796423 BACKGROUND

• Alper I, Ulukaya S, Yuksel G, Uyar M, Balcioglu T. Laparoscopic cholecystectomy pain: effects of the combination of incisional and intraperitoneal levobupivacaine before or after surgery. Agri. 2014;26(3):107-12. doi: 10.5505/agri.2014.42650.

  PMID: 25205408 BACKGROUND

• Shrestha BB, Lakhe G, Ghimire P. Postoperative Pain after Laparoscopic Cholecystectomy in a Tertiary Care Center: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2024 Jul 31;62(276):502-506. doi: 10.31729/jnma.8719.

  PMID: 39369396 BACKGROUND

• De Cassai A, Sella N, Geraldini F, Tulgar S, Ahiskalioglu A, Dost B, Manfrin S, Karapinar YE, Paganini G, Beldagli M, Luoni V, Ordulu BBK, Boscolo A, Navalesi P. Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis. Korean J Anesthesiol. 2023 Feb;76(1):34-46. doi: 10.4097/kja.22366. Epub 2022 Nov 8.

  PMID: 36345156 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nurefsan Sadikoglu, MD

  Cukurova University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurefsan Sadikoglu, MD

CONTACT

+(90) 538 926 2414; nurefsansadikoglu@gmail.com

Zehra Hatipoglu, MD

CONTACT

+(90) 532 447 1670; hatipogluzehra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator assessing postoperative pain scores will be blinded to the intervention group allocation. Patients and anesthesia providers will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Specialist

Model Details: Participants will be randomly assigned to one of three parallel study arms: (1) paravertebral block, (2) external oblique intercostal block, or (3) intravenous patient-controlled analgesia (PCA) with tramadol. Each participant will receive only the intervention assigned to their group, and no crossover between groups will occur. Outcomes will be assessed over the first 24 postoperative hours following laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: De-identified individual participant data will be available beginning 6-12 months after publication of the primary results and for a period of up to 3 years thereafter.
• Access Criteria: Researchers seeking access to the data will be required to submit a methodologically sound proposal and sign a data-use agreement to ensure confidentiality and compliance with ethical standards. Requests will be evaluated by the study investigators and relevant institutional authorities.

Locations

TU (1)