Efficacy of Adding Dexmedetomidine Versus Ibuprofen as an Adjuvant to Intraperitoneal Bupivacaine for Pain Control After Laparoscopic Gynecological Procedures

NCT06046105 | Unknown Phase 2 FDA Drug

• 1 other identifier: FMASU R131/2023
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the analgesic efficacy of adding dexmedetomidine versus ibuprofen to bupivacaine for intraperitoneal instillation after laparoscopic gynecological procedures. The main questions to answer are:

• Which is more effective for controlling postoperative pain within the first 24 hours after the procedure?
• Which is more convenient for the patients with fewer side effects and opioid consumption? Participants will be asked to assess
• The postoperative pain severity by VAS score
• The onset of the first analgesic request
• The incidence of side effects like nausea and vomiting Researchers will compare the dexmedetomidine group, the ibuprofen group, and the bupivacaine (control) group to see which one will be superior to the others.

Conditions

Postoperative Pain, Acute

Keywords

dexmedetomidine, ibuprofen, bupivacaine, intraperitoneal, gynecological, laparoscopic, analgesia

Outcome Measures

Primary Outcomes (1)

• effect on postoperative pain control

  Assessment of postoperative pain severity by Visual analog score (VAS score) (at 0 (the point of full recovery state at PACU), 6 hr., 12 hr., 18 hr., and 24 hr. after the end of the procedure) will be assessed.

  24 hours after the procedure

Secondary Outcomes (4)

• Postoperative opioid consumption

  24 hours after the procedure

• The onset of the first analgesic request

  Within 24 hours after the procedure

• Patient satisfaction

  After 24 hours of the procedure

• Incidence of postoperative side effects

  Within 24 hours after the procedure

Study Arms (3)

Bupivacaine group (Group B) (control group)

SHAM COMPARATOR

Patients will receive 50 ml of Bupivacaine 0.25% (125mg) diluted in 100 ml of normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.

Drug: Administering intraperitoneal bupivacaine for pain control after laparoscopic gynecological procedures

Bupivacaine/Ibuprofen group (Group BI)

EXPERIMENTAL

Patients will receive 50 ml of Bupivacaine 0.25% (125 mg) + 400 mg Ibuprofen diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.

Drug: Administering intraperitoneal bupivacaine plus Ibuprofen for pain control after laparoscopic gynecological procedures

Bupivacaine/Dexmedetomidine group (Group BD):

ACTIVE COMPARATOR

Patients will receive 20 ml of bupivacaine 0.25% (125 mg) + 1 µq/kg dexmedetomidine diluted in 100 ml normal saline. The drug will be injected intraperitoneally through trocars at the end of the surgery.

Drug: Administering intraperitoneal bupivacaine plus Dexmedetomidine for pain control after laparoscopic gynecological procedures

Interventions

Administering intraperitoneal bupivacaine for pain control after laparoscopic gynecological procedures DRUG

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg. Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg). All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg. At the end of the procedure bupivacaine injection will be given by the surgeon through trocars intraperitoneally. Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9. During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.

Bupivacaine group (Group B) (control group)

Administering intraperitoneal bupivacaine plus Dexmedetomidine for pain control after laparoscopic gynecological procedures DRUG

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg. Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg). All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg. At the end of the procedure bupivacaine plus Dexmedetomidine injection will be given by the surgeon through trocars intraperitoneally. Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9. During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.

Bupivacaine/Dexmedetomidine group (Group BD):

Administering intraperitoneal bupivacaine plus Ibuprofen for pain control after laparoscopic gynecological procedures DRUG

All patients will receive a standardized general anesthetic. Intravenous induction will be achieved with propofol, fentanyl (up to 2 µg/kg), rocuronium 0.6 mg/kg, and ondansetron 4 mg. Anesthesia will be maintained with 50% oxygen/ air mixture and isoflurane, intravenous fentanyl boluses (up to 3 µg/kg), rocuronium to maintain muscle relaxation, and intravenous fluids administered as Ringer's lactate (minimum of 20 mL/kg). All incision sites were infiltrated with 0.25% bupivacaine, and CO2 insufflation pressure was limited to a maximum of 15 mmHg. At the end of the procedure bupivacaine plus Ibuprofen injection will be given by the surgeon through trocars intraperitoneally. Patients will be transferred to the post-anesthetic care unit (PACU) and the Modified Aldrete Score will be assessed and discharged after fulfilling an Aldrete score of ≥9. During the first 24 hr. after surgery, all patients will receive 1 gm paracetamol i.v. every 8 hr.

Bupivacaine/Ibuprofen group (Group BI)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with American Society of Anesthesiologists (ASA) physical status 1-2 scheduled for a Laparoscopic gynecological procedure.

You may not qualify if:

• History of allergy to the medications used in the study.
• Contraindication as local infection at the site of port insertion.
• Severe cardiac (NYHA ≥Ⅲ or pulmonary dysfunction (known COPD, previous thoracic surgeries, or recent pulmonary infection).
• Severe hepatic impairment (Child C) (INR≥2, Albumin≤2.5).
• Severe Renal dysfunction (creatinine clearance \< 30).
• Neurologic, a psychiatric or mental disorder affecting the patient's ability to interpret VAS score.
• Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
• Patients who were converted to open surgery.
• ASA Ⅲ-Ⅳ.
• Patient refusal.
• Emergency operations.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (8)

• Memedov, C. et al. (2008) "Comparison of analgesic effects of intraperitoneal Lornoxicam and Ropivacaine administration in laparoscopic cholecystectomy.," Medical Journal of Trakya University [Preprint]. Available at: https://doi.org/10.5174/tutfd.2008.01046.2.

  BACKGROUND

• Cunningham TK, Draper H, Bexhell H, Allgar V, Allen J, Mikl D, Phillips K. A double-blinded randomised controlled study to investigate the effect of intraperitoneal levobupivacaine on post laparoscopic pain. Facts Views Vis Obgyn. 2020 Oct 8;12(3):155-161.

  PMID: 33123690 BACKGROUND

• Wei X, Yao X. The Impact of Intraperitoneal Levobupivacaine on Pain Relief After Laparoscopic Cholecystectomy: A Meta-analysis of Randomized Controlled Studies. Surg Laparosc Endosc Percutan Tech. 2020 Feb;30(1):1-6. doi: 10.1097/SLE.0000000000000742.

  PMID: 31913214 BACKGROUND

• Elnabtity AM, Ibrahim M. Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative pain management in children undergoing laparoscopic appendectomy: A prospective randomized trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):399-405. doi: 10.4103/sja.SJA_760_17.

  PMID: 30100838 BACKGROUND

• Gago Martinez A, Escontrela Rodriguez B, Planas Roca A, Martinez Ruiz A. Intravenous Ibuprofen for Treatment of Post-Operative Pain: A Multicenter, Double Blind, Placebo-Controlled, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0154004. doi: 10.1371/journal.pone.0154004. eCollection 2016.

  PMID: 27152748 BACKGROUND

• Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.

  PMID: 20642488 BACKGROUND

• Moss JR, Watcha MF, Bendel LP, McCarthy DL, Witham SL, Glover CD. A multicenter, randomized, double-blind placebo-controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy. Paediatr Anaesth. 2014 May;24(5):483-9. doi: 10.1111/pan.12381. Epub 2014 Mar 20.

  PMID: 24646068 BACKGROUND

• Raof RA, El Metainy SA, Alia DA, Wahab MA. Dexmedetomidine decreases the required amount of bupivacaine for ultrasound-guided transversus abdominis plane block in pediatrics patients: a randomized study. J Clin Anesth. 2017 Feb;37:55-60. doi: 10.1016/j.jclinane.2016.10.041. Epub 2016 Dec 28.

  PMID: 28235529 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Dexmedetomidine; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Wael S El Gharabawy, MD

CONTACT

+201096973949; gharabawy76@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study drugs will be prepared in a ready-to-inject form by a separate anesthesiologist who is not involved in the study. This way, neither the patient nor the anesthesiologist administering the drug will be aware of the type of medication being used. The physician who will gather patient data is also unaware of the medications administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesiology, ICU, pain management

Model Details: Randomized controlled comparative prospective clinical trial

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share