Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616441
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-12-04
Brief Title:
The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 canals 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 patients hospital stay and mobility
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 canals 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 patients 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 15 microgramkg fentanyl IV induction of anathesia 2mgkg Propofol IV 05 mgkg 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 02 after laparoscopic procedure before removing trocars
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 15 microgramkg fentanyl IV induction of anathesia 2mgkg Propofol IV 05 mgkg 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 02 after laparoscopic procedure before removing trocars
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None