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The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy

The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06616441
Enrollment
80
Registered
2024-09-27
Start date
2023-06-01
Completion date
2024-09-15
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Brief summary

Pain after surgical laparoscopy is due to various causes, such as : trocar insertion stimulating somatic pain receptors in the skin ,chemical irritation of peritoneal nerves due to abdominal distension by CO2 which is transformed into carbonic acid in nerves, distention secondary to pneumoperitoneum causes mechanical irritation of visceral and parietal nerves of the peritoneum, furthermore the surgical intervention causing injury and inflammation of the tissues, spillage of blood or serous fluid causing more irritation to the visceral and parietal nerves of the peritoneum which leads to visceral dull aching pain referred mainly to the distribution of the nerve dermatomal area. Unfortunately, pain is the major complaint of the patients, thus making its evaluation a fundamental requisite in the outcome assessment in our practice. Pain intensity, duration and related disability are the aspects that define pain and its effects. For each of these aspects, different assessment tools exist. Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. There are numerous interventions that are associated with reduction in the incidence, severity or both of pain or a reduction in analgesia requirements for women having surgical laparoscopy for gynecological purposes. Bupivacaine, is a local anesthetic. In nerve blocks, it is injected around the nerve that supplies a certain area, or into the spinal canal's epidural space, bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells, which prevents depolarization. Without depolarization, no initiation or conduction of a pain signal can occur. Hence the idea of our study is to instill bupivacaine in a certain concentration in the peritoneal cavity in an attempt to reduce postoperative pain after surgical laparoscopy for gynecological purposes that will inflect certainly on patient's hospital stay and mobility.

Detailed description

This randomized controlled trial will be conducted for (80) women undergoing laparoscopic procedures at endoscopy unit at El-Shatby Maternity University Hospital, after approval of ethical committee of Alexandria Faculty of Medicine. Randomization will be through opaque sealed envelopes. After signing their informed consents, the patients who are included in the study will be divided into two groups each group include (60) patients. Group A: Patients that will receive intraoperative instillation of bupivacaine. Group B: (Control group) that will not receive the medication. The patients in both groups will be subjected to: Pre-operative: History taking (gynecological, obstetric, medical any drug reaction and surgical), general examination and abdominal examination. Intra-operative: premedication : 1.5 microgram/kg fentanyl IV induction of anathesia: 2mg/kg Propofol IV , 0.5 mg/kg Atracurium IV , ventilation via face mask 2-3 minutes , then endotracheal intubation 1gm paracetamol IV as intraoperative analgesia which will not interfere with postoperative pain scoring. Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.

Interventions

DRUGBupivacaine

Group (A) only will receive intra-peritoneal 40 ml bupivacaine 0.2%, after laparoscopic procedure before removing trocars.

Sponsors

El Shatby University Hospital for Obstetrics and Gynecology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

1. Patients those are indicated for surgical laparoscopy, whatever the gynecological problem. 2. Age between (18-50) years. 3. Cooperative patient that can express pain and score it.

Exclusion criteria

1. Non-cooperative patients that cannot express and score pain. 2. Drug abusers due to altered pain threshold. 3. Surgical laparoscopy indicated for oncological procedures. 4. Any allergy or reaction to any of the derivatives of bupivacaine drug group. 5. Any cardio-pulmonary condition.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.up to 1 dayEvaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.

Secondary

MeasureTime frameDescription
Assessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.up to 1 dayAssessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.
Frequency of analgesia requested by the patient in postoperative period.up to 1 dayFrequency of analgesia requested by the patient in postoperative period.
Assessment of the time passed postoperative since the patient start mobilityup to 1 dayAssessment of the time passed postoperative since the patient start mobility

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026