NCT06616441

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

Completed Phase 3 Last updated 27 September 2024

What this trial tests

Phase 3 trial testing Bupivacaine in Post Operative Pain in 80 participants. Completed in 15 September 2024.

Timeline

1 June 2023

Primary endpoint
15 September 2024

15 September 2024

Quick facts

Lead sponsor	El Shatby University Hospital for Obstetrics and Gynecology
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 June 2023
Primary completion	15 September 2024
Estimated completion	15 September 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →

Conditions studied

• Post Operative Pain — all drugs for Post Operative Pain →

Sponsor

El Shatby University Hospital for Obstetrics and Gynecology

Who can join

Eligibility, female only, with Post Operative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.