Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy

• Sponsor: Petrovsky National Research Centre of Surgery (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04848363
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

Comparison of the effectiveness: Quadratus lumborum (QL) block by levobupivacaine with placebo.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Quadratus lumborum block	N/A

Detailed Description

All patients will receive standard anaesthesia using fentanyl, protocol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score.

All patients will receive post operative multimodal analgesia using paracetamol, ketoprofen, tramadol, and trimeperidine if numerical rating scale > 3 The study assumes use of QL block by levobupivacaine.in comparison with placebo in order to demonstrate the effectiveness of QL block during the operation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Distribution: randomized Intervention model: parallel distribution 2 groups Control group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. Before surgery will be performde bilateral blockade of the QL muscle with normal saline. Study group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. The QL blockade will be performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.Distribution: randomized Intervention model: parallel distribution 2 groups Control group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. Before surgery will be performde bilateral blockade of the QL muscle with normal saline. Study group: patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. The QL blockade will be performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Triple blindness. The Principal Investigator performing the blockade knows the randomization group. The anesthesiologist, postoperative pain assessor, and study participant do not know the randomization group.
• Primary Purpose: Treatment
• Official Title: Analgesic Effect of Quadratus Lumborum Block in Laparoscopic Hemicolectomy
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before the operation, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of a solution of levobupivacaine 2.5 mg / ml.	Procedure: Quadratus lumborum block; QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
Placebo Comparator: Control group patients receiving general anesthesia with propofol, fentanyl and cisatracurium for induction and sevoflurane, fentanyl and cisatracurium for maintaining anesthesia. Patients receiving postoperative multimodal intravenous analgesia with paracetamol, ketoprofen, tramadol, and trimeperidine. In this group, after induction of anesthesia before surgery, bilateral blockade of the square dorsi muscle is performed under ultrasound guidance using 20 ml of saline.	Procedure: Quadratus lumborum block; QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.

Outcome Measures

Primary Outcome Measures

1. NRS (Numeric rating scale) [two hours after surgery]

   NRS scale 0-10, "no pain"; 10, "worst pain imaginable"

Secondary Outcome Measures

1. The need for opioid analgesics during surgery [on operations]

2. The need for opioid analgesics for postoperative pain relief [72 hours after surgery]

3. The need for antiemetic drugs to relieve postoperative nausea and vomiting [12 hours after the surgery]

4. Occurrence of prolonged post-operative ileus [first two weeks after surgery]

5. Blood glucose level [after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery]

6. The level of blood lactate [after induction into anesthesia, immediately after the end of the surgery, 12 hours after the surgery]

7. The level of cortisol in the blood [after induction into anesthesia and immediately after the end of the surgery]

8. The level of prolactin in the blood [after induction into anesthesia and immediately after the end of the surgery.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who have undergone left-sided or right-sided laparoscopic hemicolectomy.

• Patient's willingness and ability to sign an informed consent document

Exclusion Criteria:

• Allergy to local anesthetics

• Chronic pain syndrome and associated opioid use.

• Coagulopathy

• Uncontrolled diabetes mellitus

• Physical Status Classification System scale above 3

• Diseases associated with the pathology of the hypothalamus

• Diseases associated with the pathology of the pituitary gland

• Diseases associated with the pathology of the adrenal glands

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)	Moscow		Russian Federation	119991

Sponsors and Collaborators

• Petrovsky National Research Centre of Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evgenii Bespalov,MD, Doctor of the department of anesthesiology and resuscitation, Petrovsky National Research Centre of Surgery
• ClinicalTrials.gov Identifier: NCT04848363
• Other Study ID Numbers: BEK25011994
• First Posted: Apr 19, 2021
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jun 18, 2021