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

NCT06616441 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 0107909
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.

  Evaluate the efficacy of instilling bupivacaine intraperitoneal in reducing postoperative pain after surgical laparoscopy for gynecologic procedures.

  up to 1 day

Secondary Outcomes (3)

• Assessment of the timing passed postoperative, since the patient needs to start the first analgesic dose.

  up to 1 day

• Frequency of analgesia requested by the patient in postoperative period.

  up to 1 day

• Assessment of the time passed postoperative since the patient start mobility

  up to 1 day

Study Arms (2)

Grouo A

ACTIVE COMPARATOR

Patients that will receive intraoperative instillation of bupivacaine.

Drug: Bupivacaine

Group B

NO INTERVENTION

(Control group) that will not receive the medication.

Interventions

Bupivacaine DRUG

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

Grouo A

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• El Shatby University Hospital for Obstetrics and Gynecology: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, Egypt

Location

Related Publications (13)

• Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20.

  PMID: 32206659 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

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

• Adlan ASA, Azhary JMK, Tarmidzi HZM, Kamarudin M, Lim RCS, Ng DSW. Post Laparoscopy Pain Reduction Project I (POLYPREP I): intraperitoneal normal saline instillation-a randomised controlled trial. BMC Womens Health. 2022 Apr 12;22(1):116. doi: 10.1186/s12905-022-01696-z.

  PMID: 35413905 BACKGROUND

• Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.

  PMID: 31517775 BACKGROUND

• Kaloo P, Armstrong S, Kaloo C, Jordan V. Interventions to reduce shoulder pain following gynaecological laparoscopic procedures. Cochrane Database Syst Rev. 2019 Jan 30;1(1):CD011101. doi: 10.1002/14651858.CD011101.pub2.

  PMID: 30699235 BACKGROUND

• Jimenez Cruz J, Diebolder H, Dogan A, Mothes A, Rengsberger M, Hartmann M, Meissner W, Runnebaum IB. Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:11-6. doi: 10.1016/j.ejogrb.2014.05.001. Epub 2014 May 13.

  PMID: 24965972 BACKGROUND

• Arden D, Seifert E, Donnellan N, Guido R, Lee T, Mansuria S. Intraperitoneal instillation of bupivacaine for reduction of postoperative pain after laparoscopic hysterectomy: a double-blind randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):620-6. doi: 10.1016/j.jmig.2013.03.012. Epub 2013 May 22.

  PMID: 23706546 BACKGROUND

• Manjunath AP, Chhabra N, Girija S, Nair S. Pain relief in laparoscopic tubal ligation using intraperitoneal lignocaine: a double masked randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):110-4. doi: 10.1016/j.ejogrb.2012.06.035. Epub 2012 Jul 21.

  PMID: 22819575 BACKGROUND

• Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.

  PMID: 22763313 BACKGROUND

• Malhotra N, Chanana C, Roy KK, Kumar S, Rewari V, Sharma JB. To compare the efficacy of two doses of intraperitoneal bupivacaine for pain relief after operative laparoscopy in gynecology. Arch Gynecol Obstet. 2007 Oct;276(4):323-6. doi: 10.1007/s00404-007-0337-1. Epub 2007 Jul 25.

  PMID: 17653742 BACKGROUND

• Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.

  PMID: 16036193 BACKGROUND

• Buck L, Varras MN, Miskry T, Ruston J, Magos A. Intraperitoneal bupivacaine for the reduction of postoperative pain following operative laparoscopy: a pilot study and review of the literature. J Obstet Gynaecol. 2004 Jun;24(4):448-51. doi: 10.1080/01443610410001685637.

  PMID: 15203590 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Aly Hussein, Dr

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: primary investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: September 27, 2024
• Study Start: June 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)