Different Maneuvers for Reducing Post-laparoscopic Pain

Not Applicable

Completed

• Conditions: Gynecologic Disease
• Interventions: Procedure: group C; Procedure: Group L; Procedure: Group LR; Procedure: Group LS

• Registration Number: NCT04475809
• Lead Sponsor: Zagazig University

Brief Summary

* Laparoscopic surgeries are becoming more attractive because of early recovery. However, post-laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site

* Many strategies have been attempted, such as the use of nonsteroidal anti-inflammatory drugs; however, the effect is limited, and there are no reliable methods available yet.

* Recently, some techniques are introduced that can potentially alleviate various types of pain through different mechanisms in patients after laparoscopic surgery such as low-pressure pneumoperitoneum, intraperitoneal normal saline infusion, and pulmonary recruitment maneuvers.

* the investigators conduct this randomized controlled trial to evaluate the effectiveness of different strategies on reducing the intensity of post-laparoscopic shoulder and abdominal pain in patients undergoing laparoscopic gynecologic surgeries.

Detailed Description

Laparoscopic surgery is becoming more popular due to smaller incision, faster recovery, less postoperative pain, and earlier returns to normal activity . However post-laparoscopic shoulder and upper abdominal pain may upset the patient more than the pain at the incision site. The incidence of shoulder pain after laparoscopic gynecological surgery varies from 35% to 80% and could be so severe at 24 hours after laparoscopic hysterectomy as well.

The mechanism of post laparoscopic shoulder and abdominal pain attributes to the insufflated co2 in the abdominal cavity and become entrapped between the liver and the right diaphragm causing irritation of the phrenic nerve, diaphragm and referred pain in the C4 dermatome. On the other hand, the prolonged exposure to residual CO2 dissolution leads to intra-abdominal acidosis and consequent peritoneal irritation and abdominal pain.

As long as the retention of CO2 is the key factor in the laparoscopy-induced shoulder and abdominal pain, many strategies have been evolved to alleviate different types of pain in patients undergoing laparoscopic surgeries such as usage of low-pressure pneumoperitoneum (8-10 mmHg) that result in reducing the intensity of postoperative pain in comparison to standard high-pressure pneumoperitoneum (12-15 mmHg). Although this low pressure may impair visualization and jeopardize the surgeon's comfort during surgery, this method is proven to be safe and feasible.

One of the maneuvers that have been proposed is an intraperitoneal normal saline infusion (IPS) that increases intraperitoneal pressure to enhance the removal of residual CO2, as well as offers a physiologic buffer system to wash out excess CO2.

Pulmonary recruitment maneuvers (PRM) has also a potential beneficial effect on alleviating post-laparoscopic pain by mechanically increasing intraperitoneal pressure to accelerate the elimination of residual CO2.

Because these variable techniques are mediated through different mechanisms, the investigators hypothesize that combination of two different maneuvers may be ideal and more effective in reducing post-laparoscopic shoulder and abdominal pain than any single or standard maneuver in patients undergoing laparoscopic gynecologic surgeries.

Study Timeline

• Study Start: 2020-07-13
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patient acceptance.
• BMI ≤35 kg/m2.
• ASA I and ASA II.
• Scheduled for elective laparoscopic gynecologic surgeries for benign lesions under general anesthesia.

Exclusion Criteria

• Patients with pre-existing chronic pain disorders.
• Patients on opioid or sedative use.
• Psychological and mental disorders.
• Severe hypertensive, cardiac, hepatic and renal patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	group C	high intra-abdominal pressure
Group L	Group L	low intra-abdominal pressure
Group LR	Group LR	low intra-abdominal pressure with pulmonary recruitment maneuver group
Group LS	Group LS	low intra-abdominal pressure with intraperitoneal saline infusion group

Primary Outcome Measures

Name	Time	Method
changes in assessment of shoulder, abdominal and incisional pain	at 1, 2, 4, 6, 12, 24, 48,72,96 hours postoperatively	will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

Secondary Outcome Measures

Name	Time	Method
Time of first request of analgesia	within 24 hour postoperative	time elapsed from patient arrival to post anesthesia care unit to time of first patient call for analgesia
Total rescue analgesic requirement	during the first postoperative 96 hours	if VAS ≥3 or on patient request, rescue analgesia will be given

Trial Locations

Locations (1)

Faculty of medicine, zagazig university; 🇪🇬 Zagazig, Elsharqya, Egypt