NCT05284695

Brief Summary

Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery \[1\]. Opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. Providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgeryThe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (TAP), rectus sheath block (RB), the erector spinae plane block (ESPB) and the external oblique intercostal block (EOI). In this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at VKV American Hospital between January 2019 and December 2021 were reviewed retrospectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

February 25, 2022

Last Update Submit

March 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesia

    Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined

    0 - 24 hours

Study Arms (3)

TAP + RB

transversus abdominis plane block and rectus sheath block

Procedure: Bariatric surgery

ESPB

Erector spinae plane block

Procedure: Bariatric surgery

EOI

External oblique intercostal block

Procedure: Bariatric surgery

Interventions

Patients undergoing elective bariatric surgery

EOIESPBTAP + RB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Fascial plane blocks and postoperative analgesia efficacy were investigated in bariatric surgery patients.

You may qualify if:

  • Patients undergoing elective bariatric surgery

You may not qualify if:

  • Patients with a history of cerebrovascular events
  • Alzheimer's and dementia
  • inadequate cognitive functions
  • history of chronic pain
  • long-term opioid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hsopital

Istanbul, 34365, Turkey (Türkiye)

Location

Related Publications (6)

  • Park CH, Nam SJ, Choi HS, Kim KO, Kim DH, Kim JW, Sohn W, Yoon JH, Jung SH, Hyun YS, Lee HL; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Comparative Efficacy of Bariatric Surgery in the Treatment of Morbid Obesity and Diabetes Mellitus: a Systematic Review and Network Meta-Analysis. Obes Surg. 2019 Jul;29(7):2180-2190. doi: 10.1007/s11695-019-03831-6.

    PMID: 31037599BACKGROUND
  • Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.

    PMID: 29077813BACKGROUND
  • Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.

    PMID: 30802933BACKGROUND
  • Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

    PMID: 28403427BACKGROUND
  • Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.

    PMID: 28085788BACKGROUND
  • Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • sami kaan coşarcan

    American hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 17, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 2, 2025

Record last verified: 2022-03

Locations