Pain Management in Laparoscopic Living-donor Nephrectomy: The Impact of Erector Spinae Plane Block (ESPB) on Perioperative Period

NCT ID: NCT04867070

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2021-12-01

Brief Summary

Laparoscopic living donor nephrectomy (LLDN) is a safe procedure and rapid wound healing, affecting the quality of life. The physiology of postoperative pain after LLDN has been attributed to reasons such as tissue damage, residual pneumoperitoneum, and diaphragm irritation. In terms of patient comfort after LLDN, pain control is provided by IV analgesics, local anesthetic injection instead of incision, and regional techniques. Regional anesthesia techniques for postoperative pain control have become popular in recent years. Today, many blocks are performed with ultrasonography (USG) to reduce the severity of pain after laparoscopic and open surgeries. In 2016, Forero et al. erector spinae plane block (ESPB) had been defined and used successfully in thoracic and abdominal surgeries. In our clinic, peripheral nerve blocks such as intravenous patient-controlled analgesia (PCA) and ESPB are applied for postoperative analgesia. The method of analgesia is suitable for the surgery and explained to the patients. This study; In LLDN operations, it was aimed to compare the bilateral ESP block performed with USG in terms of postoperative pain scores and opioid analgesic consumption compared to patients without any block. Before the operation, the anesthesiologist in charge of the anesthesia outpatient clinic provides information about both anesthesia and postoperative pain management methods suitable for surgery. This is the standard practice in our clinic. Before anesthesia, anesthesia and analgesia methods will be briefly reminded to the patient who has come for the operation. He/she will be asked if he/she wants to apply postoperative analgesia. Block procedure will be applied to patients who want ESP block. Standard analgesia will be applied to all patients. Regardless of the study, patients who underwent LLDN operation will be interviewed in the postoperative period with or without an ESP block for postoperative analgesia. The data and postoperative evaluations of the patients who agreed to participate in the study will be recorded for study purposes. The patient data will be taken from the hospital registration system.

Conditions

Pain, Postoperative; Donor Site Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

LLDN with ESPB

The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.

Group Type: ACTIVE_COMPARATOR

NAS score

Intervention Type: DIAGNOSTIC_TEST

Participants will be recorded according to the NAS and W-BAS pain scores

LLDN without ESPB

The patient will be interviewed for participation in the study, and the pain scores of the patients who will participate in the study will be recorded according to the NAS and W-BAS scores at the first, 2nd, 12th, and 24th hours. At the end of the 24th hour, analgesic consumption will be recorded.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NAS score

Participants will be recorded according to the NAS and W-BAS pain scores

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

W-BAS score

Eligibility Criteria

Inclusion Criteria

• All patients aged 18-75 who were operated on under general anesthesia for LLDN surgery and agreed to participate in the study will be included.

Exclusion Criteria

• Participants who did not accept the study, had intraoperative complications, and whose laparoscopic operation was canceled will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Bora Dinc

Assistant Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Akdeniz University Hospital

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.

Reference Type: BACKGROUND

PMID: 22902793 (View on PubMed)

Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.

Reference Type: BACKGROUND

PMID: 29883965 (View on PubMed)

Daghmouri MA, Akremi S, Chaouch MA, Mesbahi M, Amouri N, Jaoua H, Ben Fadhel K. Bilateral Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Pract. 2021 Mar;21(3):357-365. doi: 10.1111/papr.12953. Epub 2020 Oct 25.

Reference Type: BACKGROUND

PMID: 32979028 (View on PubMed)

Other Identifiers

Pain management in LLDN

Identifier Type: -

Identifier Source: org_study_id