The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy

NCT01039441 | Completed Phase 2

• 1 other identifier: 2008-07-071
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized controlled trial was designed to compare the efficacy of a simple maneuver using lower airway pressure (30 cm H2O) and intraperitoneal instillation of bupivacaine, alone or in combination, to reduce shoulder pain after gynecologic laparoscopy. Patient aged 15-65 years, scheduled for laparoscopic surgery for benign adnexa disease will be eligible for the study. Patients will be excluded from analysis if the procedure requires conversion to a laparotomy, an operative time \> 3 hours, or interpretation of pain is impossible due to serious adverse effects 240 patients will be randomly assigned to one of four groups Upon completion of surgery, the patient is placed in the Trendelenburg position (30 degrees), and one of four procedures is followed. For group A (control), 50 ml of normal saline is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group B, a mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group C, 50 ml of normal saline is instilled under diaphragm and CO2 was removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O. The anesthesiologist holds the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon will be instructed to ensure that the trocar sleeve valve is fully open to allow the CO2 gas to escape. For group D, patients receive an instillation of a mixture of 50ml solution in combination with the clinical maneuver. Patients will be given a questionnaire with the pain question represented as a visual analog scale (VAS) preoperatively. Patients will be asked to fill out the questionnaires during the first 24 hours after surgery to determine the frequency and severity of their shoulder pain. All patients are instructed to record the pain scores regarding their shoulder pain only. The degree of postoperative shoulder pain will be assessed using VAS at 1, 6, 12, and 24 hours postoperatively. The VAS, with scores ranging from 0 (no pain) to 10 (excruciating pain), is constructed without numeration, thus allowing patients to mark a point along the scale that best represented their pain at that time. In addition, the following parameters are recorded on the case report form by the investigators: operative time, blood loss, the length of hospital stay, analgesic use, and incidence of postoperative events.

Conditions

Gynecologic Laparoscopic Surgery for Benign Adnexa Disease

Outcome Measures

Primary Outcomes (1)

• The degree of shoulder pain after gynecologic laparoscopy

  During the first 24hours after surgery; 1,6, 12, 24hr

Study Arms (4)

instillation of normal saline 50ml under the diaphragm

PLACEBO COMPARATOR

Other: normal saline

the instillation of 0.5% bupivacaine under the diaphragm

EXPERIMENTAL

Procedure: Intraperitoneal instillation of bupivacaine

CO2 removal by means of a pulmonary recruitment maneuver

EXPERIMENTAL

Procedure: CO2 removal by means of a pulmonary recruitment maneuver

the instillation of bupivacaine + CO2 removal by maneuver

EXPERIMENTAL

Procedure: Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver

Interventions

Intraperitoneal instillation of bupivacaine PROCEDURE

A mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm.

the instillation of 0.5% bupivacaine under the diaphragm

CO2 removal by means of a pulmonary recruitment maneuver PROCEDURE

CO2 is removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O

CO2 removal by means of a pulmonary recruitment maneuver

Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver PROCEDURE

the instillation of bupivacaine + CO2 removal by maneuver

normal saline OTHER

instillation of normal saline 50ml under the diaphragm

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• benign adnexa diseases which are scheduled for laparoscopic surgery

You may not qualify if:

• The procedure required conversion to a laparotomy, An operative time \> 3 hours, Interpretation of pain was impossible due to serious adverse effects.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Duk Soo Bae, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 25, 2009

Record last verified: 2008-10

Locations

KR (1)