Retrolaminar Block Versus Intraperitoneal Block for Laparoscopic Cholecystectomy

NCT05755815 | Completed

• 1 other identifier: RLB Block for cholecystectomy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Although laparoscopic cholecystectomy is a minimally invasive surgery, it causes moderate-severe pain. The aim of this study is to assess the quality of pain relief in patients who will undergo in laparoscopic cholecystectomy surgery receiving either retrolaminar block or peritoneal block by comparing and evaluating the differences between the two techniques. It is hypothesized that retrolaminar block will be comparable to peritoneal block as a promising effective alternative for analgesia for in laparoscopic cholecystectomy surgeries with fewer side effects.

Conditions

Laparoscopic Cholecystectomy

Keywords

retrolaminar block

Outcome Measures

Primary Outcomes (1)

• First analgesic request

  The time of the first analgesic request for pethidine will be recorded.

  [Time Frame: Up to 24 hours after the procedure]

Secondary Outcomes (5)

• Visual analogue score (VAS) for pain assessment

  Up to 24 hours after the procedure

• Total analgesic requirements of fentanyl

  Up to 24 hours after the procedure

• Heart rate (HR)

  Up to the end of the procedure

• Mean arterial pressure (MAP)

  Up to the end of the procedure

• .Adverse effects

  Up to 24 hours after the procedure

Study Arms (2)

Group A (RLB block)

ACTIVE COMPARATOR

Ultrasound-guided RLB block will be performed under strict aseptic precautions with patient turned to the lateral position.

Procedure: retrolaminar block

Group B (Peritoneal block)

ACTIVE COMPARATOR

Peritoneal block will be performed under strict aseptic precautions before giving an incision for the ports, and at the end of surgery and before the removal of trocars

Procedure: Peritoneal block

Interventions

retrolaminar block PROCEDURE

A high-frequency 12 MHz linear ultrasound probe will be used, patients will receive bilateral ultrasound-guided retrolaminar plane block with 20 mL of bupivacaine 0.25%. Their spines will be palpated from the vertebra prominens caudally to T7 and point will be marked to identify the spinous processes, which will be confirmed by ultrasound through counting from T12 with the characteristic last rib attached to its transverse process upward to the T7 lamina. The linear high frequency transducer (6-13 MHz) will be placed in the parasagittal plane one cm lateral to the midline. The needle will be inserted in the in-plane view of the ultrasound probe and will be advanced from downward to upward to target the T7 posterior lamina surface at an angle of 90˚ to the skin until the needle tip will be contacted the posterior surface of targeted lamina . After negative aspiration, 20 mL of bupivacaine 0.25% will be injected. The procedure was repeated following the same steps on the other side.

Group A (RLB block)

Peritoneal block PROCEDURE

before giving an incision for the ports, 20 ml of 0.25% bupivacaine will be infiltrated subcutaneously over the port sites (6 ml will be infiltrated around each midline port site and 4 ml will be infiltrated around at the lateral port sites) and at the end of surgery and before the removal of trocars, 20 ml of 0.25% bupivacaine diluted in normal saline will be instilled by the surgeon intraperitoneally at gallbladder bed and under domes of both diaphragms under direct vision with a separate catheter passed through one of the trocars.. The pressure of the gas insufflation was kept within 10-12 mm Hg in all patients. At the end of surgery, CO2 was evacuated, and intraperitoneal anesthetic solution was left in situ.

Group B (Peritoneal block)

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiology (ASA) 1 or 2 patients.
• Scheduled for laparoscopic cholecystectomy

You may not qualify if:

• Patient's refusal.
• Altered mental status or un-cooperative patients.
• History of known sensitivity to the used anesthetics.
• Bleeding or coagulation diathesis.
• Infection or redness at the injection site.
• Significant cardiac dysfunction, hepatic, or renal impairment

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (7)

• Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.

  PMID: 36307755 RESULT

• Funk RD, Hilliard P, Ramachandran SK. Perioperative opioid usage: avoiding adverse effects. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):32S-39S. doi: 10.1097/PRS.0000000000000680.

  PMID: 25255004 RESULT

• Gupta M, Naithani U, Singariya G, Gupta S. Comparison of 0.25% Ropivacaine for Intraperitoneal Instillation v/s Rectus Sheath Block for Postoperative Pain Relief Following Laparoscopic Cholecystectomy: A Prospective Study. J Clin Diagn Res. 2016 Aug;10(8):UC10-5. doi: 10.7860/JCDR/2016/18845.8309. Epub 2016 Aug 1.

  PMID: 27656533 RESULT

• Kamel AAF, Elhossieny KM, Hegab AS, Salem DAE. Ultrasound-guided Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy. Pain Physician. 2022 Sep;25(6):E795-E803.

  PMID: 36122260 RESULT

• Khandelwal H, Parag K, Singh A, Anand N, Govil N. Comparison of Subcostal Transversus Abdominis Block with Intraperitoneal Instillation of Levobupivacaine for Pain Relief after Laparoscopic Cholecystectomy: A Prospective Study. Anesth Essays Res. 2019 Jan-Mar;13(1):144-148. doi: 10.4103/aer.AER_3_19.

  PMID: 31031495 RESULT

• Mishra PK, Mani S, Singh RB. Evaluating the Efficacy of Pre-incisional Infiltration and Intraperitoneal Instillation of a Local Anesthetic Agent on Postoperative Analgesia and Hemodynamics in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia. Cureus. 2022 Mar 8;14(3):e22977. doi: 10.7759/cureus.22977. eCollection 2022 Mar.

  PMID: 35415034 RESULT

• Pizzi LT, Toner R, Foley K, Thomson E, Chow W, Kim M, Couto J, Royo M, Viscusi E. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012 Jun;32(6):502-14. doi: 10.1002/j.1875-9114.2012.01101.x. Epub 2012 May 8.

  PMID: 22570188 RESULT

Study Officials

• Amany H EL-Deeb, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: May 21, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 15, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)