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

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

Interventions

DRUG

Administering intraperitoneal bupivacaine for pain control after laparoscopic gynecological procedures

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.

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-15

Primary Completion

2024-03-01

Completion

2024-03-30

FDA Drug

Yes