The Impact Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

NCT07138053 | Active Not Recruiting DMC

• 1 other identifier: ALJ07/25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This studi compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery. Hypothesis was: opioid free anesthesia reduces postoperative pain intensity and stress response in terms of the value for pain in VAS (Visual Analog Scala) and for stress response in value of cortisol, prolactin and IL-6, CRP and improves postoperative patients subjective well-being and surgical outcome.

Conditions

Opioid Free Anesthesia; Stress Response; Postoperative Pain

Keywords

opioid; cortisol; stress response

Outcome Measures

Primary Outcomes (1)

• Postoperative stress respons

  Primari mean in difference of strens respons beatween two group of patient meserments with value of cortisol, prolacti, IL-6 and C-reactive protein and glucosa blood level

  blood samples were taken at 06:00am on the day of surgeon(basal value), 6 hours post-surgeon, at 06:00 am on the first postoperative day

Secondary Outcomes (1)

• well-being score

  The assessment of subjective well-being and pain score was performed 1,3,,6,12 ,24 and 48hours post-surgery]

Study Arms (2)

MBA group

NO INTERVENTION

anesthesia based on opioids (multimodal balancing anesthesia with opioids)

OFA group

EXPERIMENTAL

Experimental group will not receive opioids in perioperativ period

Other: OFA group

Interventions

OFA group OTHER

OFA group Premedication with Midazolame and Paracetamol 30 minutes before surgery on ward, Dexamethasona and infusion of Dexmedetomidin and 2% Lidocaine 10 min before intubation( 50mcg Dexmedetomidin and 500mg 2% Lidocaine add up to 50ml normal saline) 1ml/10kg in 10 min after intubation 1ml/10kg/h discontinued after last surgical sutures. TAP bloc ultrasound guided performed after intubation. Ketamine given 60 sec before incision in doses 0.5 mg/kg, and after if it is necessary according to ER and qNOX. Provided value range between 40-60 during surgery.

OFA group

Eligibility Criteria

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

You may qualify if:

• aged between 18 years and 65 years
• participants scheduled for elective open gynecology surgery non cancer

You may not qualify if:

• body mass index above 30 kg/m2, diabetes mellitus, emergence surgery, cardiopulmonary disease, neuromusular disease, renal disease, vaginal hysterectomy, hepatic or endocrine disease, pregnancy, mental disease, allergy to any study drugs, alcoholic or drug abuse, ASA III and IV, patient's refusal to participate in the study, duration of surgery below 30min and over 90min.

Sponsors & Collaborators

• Cantonal Hospital Zenica: lead

Study Sites (1)

Cantonal Hospital Zenica

Zenica, Zenica, 7200, Bosnia and Herzegovina

Location

Related Publications (7)

• Xia M, Ji NN, Duan ML, Tong JH, Xu JG, Zhang YM, Wang SH. Dexmedetomidine regulate the malignancy of breast cancer cells by activating alpha2-adrenoceptor/ERK signaling pathway. Eur Rev Med Pharmacol Sci. 2016 Aug;20(16):3500-6.

  PMID: 27608913 BACKGROUND

• Lersch F, Correia PC, Hight D, Kaiser HA, Berger-Estilita J. The nuts and bolts of multimodal anaesthesia in the 21st century: a primer for clinicians. Curr Opin Anaesthesiol. 2023 Dec 1;36(6):666-675. doi: 10.1097/ACO.0000000000001308. Epub 2023 Sep 19.

  PMID: 37724595 BACKGROUND

• Jameson P, Desborough JP, Bryant AE, Hall GM. The effect of cortisol suppression on interleukin-6 and white blood cell responses to surgery. Acta Anaesthesiol Scand. 1997 Feb;41(2):304-8. doi: 10.1111/j.1399-6576.1997.tb04683.x.

  PMID: 9062617 BACKGROUND

• Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.

  PMID: 28742427 BACKGROUND

• Anand S, Bhati G, Gurram R, Gnanasekaran S, Kate V, Pottakkat B, Kalayarasan R. Does Neutrophil-to-Lymphocyte Ratio (NLR) Predict Pathologic Response to Neoadjuvant Chemoradiotherapy in Patients with Esophageal Squamous Cell Carcinoma? J Gastrointest Cancer. 2021 Jun;52(2):659-665. doi: 10.1007/s12029-020-00445-5.

  PMID: 32607960 BACKGROUND

• Akeju O, Song AH, Hamilos AE, Pavone KJ, Flores FJ, Brown EN, Purdon PL. Electroencephalogram signatures of ketamine anesthesia-induced unconsciousness. Clin Neurophysiol. 2016 Jun;127(6):2414-22. doi: 10.1016/j.clinph.2016.03.005. Epub 2016 Mar 16.

  PMID: 27178861 BACKGROUND

• Akeju O, Hobbs LE, Gao L, Burns SM, Pavone KJ, Plummer GS, Walsh EC, Houle TT, Kim SE, Bianchi MT, Ellenbogen JM, Brown EN. Dexmedetomidine promotes biomimetic non-rapid eye movement stage 3 sleep in humans: A pilot study. Clin Neurophysiol. 2018 Jan;129(1):69-78. doi: 10.1016/j.clinph.2017.10.005. Epub 2017 Oct 20.

  PMID: 29154132 BACKGROUND

MeSH Terms

Conditions

Fractures, Stress; Pain, Postoperative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Asmira Ljuca, MD

  Cantonal Hospital Zenica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons and outcome assessors were masking to the treatment allocation. Masking was impossible for anesthetist because anesthetist was performed different tip of anesthesia during surgery. The outcome study were evaluated by independent assessors who were also masked because they evaluated patients after surgery on a daily base during hospital stay without knowledge of the type intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Anesthesiologist and Intensive Care Subspecialist

Model Details: The diagnostic protocol was performed in patients at the gynecology department. The patients with diagnosed non cancer pathology and who needed gynecolog surgery were prepared for the surgical procedure. After that, patients were examined to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: July 17, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

BO (1)